Context: Worldwide there is an increasing demand for Hospital at Home as an alternative to hospital admission. Although there is a growing evidence base on the effectiveness and cost-effectiveness of Hospital at Home, health service managers, health professionals and policy makers require evidence on how to implement and sustain these services on a wider scale.

(1) To identify, appraise and synthesise qualitative research evidence on the factors that influence the implementation of Admission Avoidance Hospital at Home and Early Discharge Hospital at Home, from the perspective of multiple stakeholders, including policy makers, health service managers, health professionals, patients and patients' caregivers. (2) To explore how our synthesis findings relate to, and help to explain, the findings of the Cochrane intervention reviews of Admission Avoidance Hospital at Home and Early Discharge Hospital at Home services.

We included qualitative studies and mixed-methods studies with qualitative data collection and analysis methods examining the implementation of new or existing Hospital at Home services from the perspective of different stakeholders.

Rehabilitation at home after stroke: a descriptive study of an individualized intervention.

Abstract:
To describe the content of a programme involving early hospital discharge and continued rehabilitation at home after stroke.

Quantitative and qualitative descriptive study of an intervention within the context of a randomized controlled trial.

Huddinge University Hospital, Stockholm, Sweden.

Forty-one patients, moderately impaired after stroke, rehabilitated by a team of six occupational, physical, and speech and language therapists.

The average duration of the programme was 14 weeks, the mean number of home visits 12, and the median total time consumption 23 hours and 20 minutes, of which face-to-face contact with the patient constituted 54%. The rehabilitation process was pursued by the patient and the therapist in partnership. Supported by the team the therapists incorporated a wider domain of activities than usual and left a considerable amount of the training to self-directed activities. The most common foci of the visits were speech and communication, ADL activities and ambulation. When planning the intervention the therapists paid attention to discrepancies between the desires and abilities of the patient on the one hand and environmental demands on the other - discrepancies detected through observation of the patient in the home environment.

The home environment offers therapists working in a team opportunities to adopt a behaviour that enables patients with moderate neurological impairments after stroke to resume responsibility and influence over their rehabilitation process, resulting in an individualized rehabilitation programme that varies in duration, content and frequency of home visits.

Evaluation of patients' satisfaction with hospital-at-home care.

Abstract: On July 1, 1997, in the Canton of Vaud, Switzerland, a pilot experiment of Hospital-at-Home Care (H-Hcare) was set up for a 2-year period at four sites to measure patients' satisfaction with this type of health care. Out of 174 patients referred to the H-Hcare program for a wide range of treatments, 107 were medical patients admitted for heart failure, community acquired pneumonia, or for an infectious disease requiring i.v.-antibiotherapy; 95 of these agreed to express H-Hcare satisfaction and dissatisfactions during a semistructured interview conducted 6 weeks after admission. H-Hcare was considered a viable alternative to hospitalization when the illness is not too serious, and for patients who are still independent and need little care. When patients are more severely ill, they prefer to go to hospital to avoid overburdening their caregivers and to feel more secure.

Patient and carer satisfaction with 'hospital at home': quantitative and qualitative results from a randomised controlled trial.

Abstract:
'Hospital At Home' schemes are set to increase in the United Kingdom (UK) in response to the NHS Plan. To date, little detailed work has been done on the acceptability of these schemes to patients and their carers.

To compare Hospital at Home patient and carer satisfaction with hospital care.

Pragmatic randomised controlled trial.

Consecutive patients assessed as suitablefor the Leicester Hospital at Home scheme were randomised to Hospital at Home or one of three acute hospitals in the city.

Patient satisfaction was assessed two weeks after randomisation, or at discharge if later using a six-item questionnaire. Patients' and carers' views of the services were assessed by semistructured interviews.

One hundred and two patients were randomised to Hospital at Home and 97 to hospital. Forty-eight (47%) patients in the Hospital at Home arm and 35 (36%) in the hospital arm completed the satisfaction questionnaire, representing 96% and 85% of those eligible, respectively. Total scores were significantly higher in the Hospital at Home (median = 15) than in the hospital group (median = 12). (P<0.001, Mann-Whitney U-test.) Responses to all six questions favoured Hospital at Home, with all but one of these differences being statistically significant. In the Hospital at Homegroup, 24 patients and 18 of their carers were interviewed; in the hospital group 18 patients and seven of their carers were interviewed. Themes emerging from these interviews were that patients appreciated the more personal care and better communication offered by Hospital at Home and placed great value on staying at home, which was seen to be therapeutic. Patients largely felt safe in Hospital at Home, although some would have felt safer in hospital. Some patients and carers felt that better medical care would have been provided in hospital. Carers felt that the workload imposed by Hospital at Home was no greater than by hospital admission and that the relief from care duties at home would be counterbalanced by the added strain of hospital visiting.

Patient satisfaction was greater with Hospital at Home than with hospital. Reasons included a more personal style of care and a feeling that staying at home was therapeutic. Carers did not feel that Hospital at Home imposed an extra workload.

Using cost-effectiveness analysis to compare Hospital at Home and in-patient interventions. Part 1.

Abstract: An economic analysis was conducted as an integral part of a comparison of the effectiveness and suitability of Hospital at Home (HaH) and in-patient interventions. The sample comprised of 109 adult primary total joint replacement patients and 21 of their coresident informal carers. The paper is presented in two parts. Part 1 includes the background and rationale for the study and the findings from the comparison of the effectiveness of the two interventions using multiple data collection sources. Data were collected using questionnaires, audit and semi-structured interviews. Hospital at Home was found to be significantly more effective in terms of patient satisfaction and reduced joint stiffness and as least as effective as in-patient care in relation to levels of joint pain, joint disability and incidence of postoperative complications. In addition informal carers reported 107 positive comments compared with 36 negative comments related to HaH care and all except one of the 21 carers would choose HaH again in preference to in-patient care.

Sooner and healthier: a randomised controlled trial and interview study of an early discharge rehabilitation service for older people.

Abstract:
Hospitals are under pressure from admissions of increasing numbers of older people. Older people may suffer unnecessary activity limitation after acute illnesses through lack of appropriate rehabilitation.

To evaluate an early discharge and rehabilitation service for older people.

A randomised controlled trial comparing an early discharge and rehabilitation with standard hospital aftercare. Outcome measures assessed at 3 and 12 months were the Barthel Index, Nottingham Extended Activities of Daily Living and EuroQol (for patients) the General Health Questionnaire (for patients and carers). Use of services over 12 months was recorded. An interview study of patients and staff was conducted.

The early discharge and rehabilitation service offered a home-based rehabilitation and care programme for up to 4 weeks.

370 hospitalised older medical and surgical patients were included in the randomised controlled trial. Twenty patients and 11 staff were interviewed.

Subjects in the early discharge rehabilitation service group used fewer days in hospital at 3 months (mean difference 9, median difference 4 days, 95% CI of median difference 2-8). At 3 months the early discharge and rehabilitation service patients had better Barthel scores (mean difference 1.2, 95% CI 0.4-1.9), Nottingham Extended Activities of Daily Living kitchen scores (mean difference 1.2, 95% CI 0.2-2.3), Nottingham Extended Activities of Daily Living domestic scores (mean difference 1.1, 95% CI 0.2-2.0) and General Health Questionnaire scores (mean difference 2.4, 95% CI 0.7-4.1). Significant Nottingham Extended Activities of Daily Living domestic and General Health Questionnaire benefits remained at 12 months. The early discharge and rehabilitation service carers had better General Health Questionnaire scores at 3 months (mean difference 2.0, 95% CI 0.1-3.8). The interviews suggested that the early discharge and rehabilitation service was patient-centred, set clear goals, worked as a team, and considered physical, psychological, social and environmental issues. It was found to be highly satisfactory.

Some older people can be discharged from hospital sooner, with better health outcomes using a well-staffed and organised patient-centred early discharge service providing rehabilitation.

A mixed method study to compare use and experience of hospital care and a nurse-led acute respiratory assessment service offering home care to people with an acute exacerbation of chronic obstructive pulmonary disease.

Abstract:
Over the past 10 years hospital at home schemes for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease have proliferated throughout developed countries. For selected patients treatment at home is no less advantageous in terms of readmission rates and length of stay than treatment in hospital. Although care at home might seem to be a more desirable option than admission to hospital, little is known about care preferences and how people exercise service choice.

1. to determine patients' recent use of and satisfaction with health care services during exacerbations of Chronic Obstructive Pulmonary Disease. 2. To determine and compare patients' and families' perceived future care preferences. 3. To complete an in-depth exploration of care experiences and preferences with a subset of respondents and their families.

A mixed method design was used consisting of a postal survey and in-depth qualitative interviews with a subset of questionnaire respondents.

An outreach service provided by a large university hospital within Scotland, UK.

One hundred and four out-patients registered with the Acute Respiratory Assessment Service and who had experienced hospital inpatient care during the past year, and their families. A subset of respondents was invited to take part in qualitative interviews.

The majority of respondents indicated a preference for the home care service, and this was positively associated with high coping skills. There was a strong relationship between personal and family preferences. There was no linear relationship between a clinical measure of severity of lung disease and service use or care preferences. Results from the qualitative interviews endorsed and explained these findings.

A range of factors combined to influence service use at a particular point in time, implying a need for increased self-management support from nurses and increased service provision.

A comparison of a hospital-based and two home-based rehabilitation programmes.

Abstract:
This paper compares the service models of three different types of rehabilitation programmes provided in Victoria, Australia: One hospital-based and two types of rehabilitation in the home (RITH).

Nine focus group interviews were conducted with multidisciplinary staff working in rehabilitation teams in one hospital-based and eight RITH programmes. Additional data were collected for 164 clients and 75 carers from eight of these programmes at admission, discharge and three months post discharge. Interviews were conducted with 32 clients and 14 carers.

The criteria for admission and model of rehabilitation adopted in the three programmes were similar. There were differences in programme aims, characteristics of the clients admitted and the type and level of therapy clients received, both between hospital and home-based programmes and between the three programmes. In general, staff and clients saw the home as providing a relevant context that enabled individualized, goal directed therapy for medically stable rehabilitation clients. The hospital offered an opportunity to socialize with others and specialized equipment.

Results of this study suggest clients and carers require a mix of hospital and home-based rehabilitation that is able to respond to their needs and preferences at each phase of the rehabilitation continuum.

The invisible contract: shifting care from the hospital to the home.

Abstract: The ageing population and associated burgeoning health care costs have resulted in a shift of care from institutional settings to home and community-based care. As one example, rehabilitation-in-the-home (RITH) programs are becoming increasingly prevalent. These programs either substitute or supplement in-hospital treatment by providing multidisciplinary rehabilitation and support services in the client's own home. This paper investigates the impact of RITH programs on informal carers. Semi-structured interviews carried out with caregivers and staff revealed a complex and contradictory interpretation of informal caring. Analysis of carers' interviews revealed: an assumption by themselves and others (including RITH staff) that they would provide care; the intimate, arduous and relentless work of caring; lack of consultation about discharge; lack of recognition and reimbursement; and low levels of program support for them as carers. Carers are integral to the successful rehabilitation of the client, but they occupy a marginal status within the program. An invisible contract consigns to them substantial care-work that was previously provided by the hospital. Informal carers in RITH programs can be seen as disenfranchised care contractors. This has implications for policy makers, program managers and researchers.

Using a multi-method, user centred, prospective hazard analysis to assess care quality and patient safety in a care pathway.

Abstract:
Care pathways can be complex, often involving multiple care providers and as such are recognised as containing multiple opportunities for error. Prospective hazard analysis methods may be useful for evaluating care provided across primary and secondary care pathway boundaries. These methods take into account the views of users (staff and patients) when determining where potential hazards may lie. The aim of this study is to evaluate the feasibility of prospective hazard analysis methods when assessing quality and safety in care pathways that lie across primary and secondary care boundaries.

Development of a process map of the care pathway for patients entering into a Chronic Obstructive Pulmonary Disease (COPD) supported discharge programme. Triangulation of information from: care process mapping, semi-structured interviews with COPD patients, semi-structured interviews with COPD staff, two round modified Delphi study and review of prioritised quality and safety challenges by health care staff.

Interview themes emerged under the headings of quality of care and patient safety. Quality and safety concerns were mostly raised in relation to communication, for example, communication with other hospital teams. The three highest ranked safety concerns from the modified Delphi review were: difficulties in accessing hospital records, information transfer to primary care and failure to communicate medication changes to primary care.

This study has demonstrated the feasibility of using mixed methods to review the quality and safety of care in a care pathway. By using multiple research methods it was possible to get a clear picture of service quality variations and also to demonstrate which points in the care pathway had real potential for patient safety incidents or system failures to occur. By using these methods to analyse one condition specific care pathway it was possible to uncover a number of hospital level problems. A number of safety challenges were systems related; these were therefore difficult to improve at care team level. Study results were used by National Health Service (NHS) stakeholders to implement solutions to problems identified in the review.

Implementation of the concept of home hospitalisation for heart patients by means of telehomecare technology: integration of clinical tasks.

Abstract:
To explore how the implementation of the concept 'Home hospitalisation of heart patients' by means of telehomecare technology influences the integration of clinical tasks across healthcare sectors.

Inter-organisational theory.

The case study approach was applied. Triangulations of data collection techniques were used: documentary materials, participant observation, qualitative and focus group interviews.

The clinical decision-making and task solving became multidisciplinary and integrated with the implementation of telehomecare and, therefore, complex in terms of the prescription and adjustment of patient medicine. Workflows between healthcare professionals across sectors changed from sequential to collective client flows. Pre-existing procedures for patient care, treatment, and responsibility were challenged. In addition, the number of tasks for the district nurses increased. Integration in the clinical task-solving area increases fragmentation in the knowledge technologies in a network perspective.

Implementing the concept of 'Home hospitalisation of heart patients' by means of telehomecare technology will result in a more integrated clinical task-solving process that involves healthcare professionals from various sectors. Overall, the integration of clinical tasks between hospital and district nursing will result in a direct benefit for the heart patients.


Context: The number of older people is increasing worldwide and public expenditure on residential aged care facilities (ACFs) is expected to at least double, and possibly triple, by 2050. Co-ordinated and timely care in residential ACFs that reduces unnecessary hospital transfers may improve residents' health outcomes and increase satisfaction with care among ACF residents, their families and staff. These benefits may outweigh the resources needed to sustain the changes in care delivery and potentially lead to cost savings. Our systematic review comprehensively and systematically presents the available evidence of the effectiveness, safety and cost-effectiveness of alternative models of providing health care to ACF residents.

Main objective To assess the effectiveness and safety of alternative models of delivering primary or secondary health care (or both) to older adults living in ACFs. Secondary objective To assess the cost-effectiveness of the alternative models.

We included individual and cluster-randomised trials, and cost/cost-effectiveness data collected alongside eligible effectiveness studies. Eligible study participants included older people who reside in an ACF as their place of permanent abode and healthcare professionals delivering or co-ordinating the delivery of healthcare at ACFs. Eligible interventions focused on either ways of delivering primary or secondary health care (or both) or ways of co-ordinating the delivery of this care. Eligible comparators included usual care or another model of care. Primary outcomes were emergency department visits, unplanned hospital admissions and adverse effects (defined as infections, falls and pressure ulcers). Secondary outcomes included adherence to clinical guideline-recommended care, health-related quality of life of residents, mortality, resource use, access to primary or specialist healthcare services, any hospital admissions, length of hospital stay, satisfaction with the health care by residents and their families, work-related satisfaction and work-related stress of ACF staff.

Nursing interventions for depression in newly admitted nursing home residents.

Multifaceted shared care intervention for late life depression in residential care: randomised controlled trial.

Abstract:
To evaluate the effectiveness of a population based, multifaceted shared care intervention for late life depression in residential care.

Randomised controlled trial, with control and intervention groups studied one after the other and blind follow up after 9.5 months.

Population of residential facility in Sydney living in self care units and hostels.

220 depressed residents aged >/=65 without severe cognitive impairment.

The shared care intervention included: (a) multidisciplinary consultation and collaboration, (b) training of general practitioners and carers in detection and management of depression, and (c) depression related health education and activity programmes for residents. The control group received routine care.

Geriatric depression scale.

Intention to treat analysis was used. There was significantly more movement to "less depressed" levels of depression at follow up in the intervention than control group (Mantel-Haenszel stratification test, P=0.0125). Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders, with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group (95% confidence interval 0.76 to 2.97, P=0.0011).

The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration, by enhancing the clinical skills of general practitioners and care staff, and by providing depression related health education and activity programmes for residents.

Two models of restorative nursing care in the nursing home: designated versus integrated restorative nursing assistants.

Abstract: A 6-month clinical trial was conducted to evaluate two models of restorative nursing care designed to improve mobility in nursing home residents. The models were compared on number of residents enrolled, documentation of nursing assistant (NA) compliance, and nursing staff satisfaction. The designated model, which relied on one specially trained NA to perform restorative activities on the unit, resulted in higher rates of enrollment, compliance, and staff satisfaction compared with the integrated model, which relied on regular staff NAs who were trained to incorporate restorative activities into their daily routines.

Value-added outcomes: the use of advanced practice nurses in long-term care facilities.

Abstract: The purpose of this study was to determine the effect on clinical outcomes for newly admitted nursing home residents when advanced practice gerontological nurses (APNs) worked with staff to implement scientifically based protocols for incontinence, pressure ulcers, depression, and aggressive behavior. Use of APNs in this manner differs from the usual way APNs have been used in nursing homes, in which their primary focus has been to augment the physician's role. The APN treatment was randomly assigned to two nursing homes and usual care was assigned to a third. Trajectories from admission to 6 months revealed that residents with APN input into their care (n = 86) experienced significantly greater improvement or less decline in incontinence, pressure ulcers, and aggressive behavior, and they had higher mean composite trajectory scores compared with residents receiving usual care (n = 111). Significantly less deterioration in affect was noted in cognitively impaired residents in the treatment group. Findings suggest that APNs can be effective links between current scientific knowledge about clinical problems and nursing home staff.

Better care in nursing homes: advanced practice nurses' strategies for improving staff use of protocols.

Abstract: This article describes a set of strategies used by gerontologic advanced practice nurses (GAPNs) in three nursing homes to integrate the use of protocols into the daily care of residents. The protocols were developed as part of a larger study on the quality of care in nursing homes carried out by nurse researchers at the University of Minnesota and funded by the National Institute of Nursing Research (R01-NR03490). The GAPNs worked regularly with nursing home staff to incorporate aspects of protocols into daily care routines for residents with four specific problems common in elderly residents of nursing homes: pressure ulcers, incontinence, depression, and aggressive behavior. Outcomes of the larger study showed that residents with these four problems had better outcomes in the homes in which care was planned by the GAPNs using protocols that were integrated into the daily routines of staff.

Secure Internet video conferencing for assessing acute medical problems in a nursing facility.

Abstract: Although video-based teleconferencing is becoming more widespread in the medical profession, especially for scheduled consultations, applications for rapid assessment of acute medical problems are rare. Use of such a video system in a nursing facility may be especially beneficial, because physicians are often not immediately available to evaluate patients. We have assembled and tested a portable, wireless conferencing system to prepare for a randomized trial of the system s influence on resource utilization and satisfaction. The system includes a rolling cart with video conferencing hardware and software, a remotely controllable digital camera, light, wireless network, and battery. A semi-automated paging system informs physicians of patient s study status and indications for conferencing. Data transmission occurs wirelessly in the nursing home and then through Internet cables to the physician s home. This provides sufficient bandwidth to support quality motion images. IPsec secures communications. Despite human and technical challenges, this system is affordable and functional.

Case management model or case manager type? That is the question.

Abstract: Case management models have been categorized many different ways, but classification into two generic models is proposed here: an interrogative model that relies on intense oversight with expected cost reduction and a patient advocacy model that relies on a brokering arrangement for services in the best interest of the patient. A randomized trial in an elderly, functionally impaired population resulted in the implementation of a patient advocacy model and suggests that this model results in increased service use and costs, but that increased survival rates may justify the additional cost.

The value of specialist clinical assessment of older people prior to entry to care homes.

Abstract:
to ascertain the value of employing a specialist clinician's contribution to the assessment of older people prior to care home entry.

randomised controlled trial.

256 older people at risk of care home entry were randomly allocated to either a control group, who received the usual care management assessment, or to an experimental group who, in addition, received a clinical assessment by a geriatrician or old age psychiatrist. The value of the additional assessment was evaluated by an analysis of clinical recommendations, questionnaires eliciting the views of stakeholders and research interviews with older people and their carers at initial assessment and 6 months. Data on service use and costs over 6 months and on destination at 6 and 12 months were also collected.

the clinical assessment uncovered covert morbidity previously unknown to care managers particularly in respect of cognitive impairment and was adjudged acceptable to the different stakeholders involved. Those receiving the clinical assessment experienced less deterioration in their physical functioning, had less contact with nursing homes and emergency services and their carers experienced reduced levels of distress. Overall, the costs of care for those receiving the assessment were no greater with NHS costs actually lower.

the potential benefits in involving specialist clinicians in the assessment process include identifying previously undiagnosed conditions and enhancing care managers' decision making. Such an assessment could be provided at a modest marginal cost. The approach is fully compatible with proposals for the role of the community geriatrician and commensurate with current good clinical practice in old age psychiatry.

Identifying undiagnosed dementia in residential care veterans: comparing telemedicine to in-person clinical examination.

Abstract:
Dementia is a common but frequently undiagnosed problem in aging. Barriers to early diagnosis include a lack of routine screening for dementia and a lack of access to specialty consultative services. We conducted a pilot study to see if telemedicine could provide reliable, accurate geriatric consultative services to evaluate patients for dementia who were residing at remote sites.

This was a prospective cohort study that compared the diagnostic reliability of telemedicine to an in-person examination for dementia. Eligible subjects were residents of a Washington State Veterans' Home, age 60 years or older, with no prior diagnosis of dementia. Eligible subjects were screened for dementia using the 7-Minute Screen. Veterans who screened positive and consented to participate in the study received an in-person neuropsychiatric evaluation at baseline, and then both telemedicine and in-person examinations for dementia conducted by experienced geriatric psychiatrists. The accuracy of the telemedicine diagnosis was estimated by comparing it to the diagnosis from the clinical examination. Three geriatric psychiatrists who were blinded to the results of the clinical examination conducted the telemedicine and in-person examinations. We also assessed attitudes of the subjects and geriatric psychiatrists towards the telemedicine sessions.

Eighteen of 85 subjects screened were 'positive' for dementia on the 7 Minute Screen. Of these, 16 consented to participate in the telemedicine study. Twelve of the 16 subjects were subsequently diagnosed with dementia by the telemedicine examination. The telemedicine diagnoses were in 100% agreement with the diagnoses from the in-person clinical examinations. Moreover, the subjects reported a high degree of satisfaction with the telemedicine experience and that they would like to have further care through telemedicine in the future. The geriatric psychiatrists reported technical difficulties with the audio-visual quality of telemedicine in the initial phases of the project that resolved as familiarity with the telemedicine equipment increased. None of these problems had an adverse impact on the diagnostic accuracy of telemedicine.

We found that telemedicine was as accurate as an in-person clinical examination in establishing the diagnosis of dementia. In addition, subjects reported a high degree of satisfaction with telemedicine and a willingness to participate in telemedicine clinical care in the future. Given the large increase in the aging population and the shortage of geriatric psychiatrists nationally, it appears that telemedicine may be a promising means to expand the availability of geriatric psychiatric consultation to remote areas.

The assessment of a hospital-based care management model for long-term care services.

Abstract: The purpose of this research was to assess the effectiveness of a hospital-based care management model on disabled elderly people. A before-and-after quasi- experimental design was adopted. A total of 331 disabled elderly people, residing in the Da-An District of Taipei City, participated in the study. Among them, 166 received care management, while the other 165 did not. The latter served as controls. Baseline and follow-up data collection were carried out before and after care management intervention. Logistic regression analysis was used to test the effects of care management on medical care expenditure, self-rated health, and satisfaction with long-term care arrangement. The results showed that those under care management, compared to the controls, were more likely to experience a decrease in medical care expenditure, and less likely to have a decrease in satisfaction with long-term care. The effects were statistically significant. However, there was no effect on self-rated health. The findings show that hospital-based care management is a viable option and has the potential to become an important segment in the delivery of long-term care services. More effort should be expended in its development and in the evaluation of its effectiveness.


Context: Choosing an optimal reconstruction method is pivotal for patients with gastric cancer undergoing distal gastrectomy. The uncut Roux-en-Y reconstruction, a variant of the conventional Roux-en-Y approach (or variant of the Billroth II reconstruction), employs uncut devices to occlude the afferent loop of the jejunum. This modification is designed to mitigate postgastrectomy syndrome and enhance long-term functional outcomes. However, the comparative benefits and potential harms of this approach compared to other reconstruction techniques remain a topic of debate.

To assess the benefits and harms of uncut Roux-en-Y reconstruction after distal gastrectomy in patients with gastric cancer.

We included randomised controlled trials (RCTs) and quasi-RCTs comparing uncut Roux-en-Y reconstruction versus other reconstructions after distal gastrectomy for gastric cancer. The comparison groups encompassed other reconstructions such as Billroth I, Billroth II (with or without Braun anastomosis), and Roux-en-Y reconstruction.

Improvement of the Roux limb function using a new type of "uncut Roux" limb.

Abstract:
The Roux stasis syndrome is characterized by symptoms of upper gut stasis following Roux-en-Y gastrojejunostomy. The aim of this study was to compare a new type of uncut Roux-en-Y gastrojejunostomy with the conventional Roux-en-Y gastrojejunostomy after subtotal gastrectomy.

51 patients (31 men and 20 women) had the conventional Roux-en-Y reconstruction and 54 patients (38 men and 16 women) had the new type of uncut Roux-en-Y reconstruction. The new type of uncut Roux-en-Y gastrojejunostomy consisted of an artificial jejunal occlusion and a short Roux limb (20 to 30 cm).

The criteria included one of the four following conditions at the time of follow-up: chronic abdominal pain, postprandial fullness, persistent nausea, and intermittent vomiting that are worsened by eating. According to the criteria, the Roux stasis syndrome occurred in 19 patients (37.3%) with conventional Roux-en-Y reconstruction, and in 10 patients (18.5%) with uncut Roux-en-Y reconstruction (P = 0.033).

A new type of Roux operation is able to alleviate not only the Roux stasis syndrome but also alkaline reflux gastritis or esophagitis by preserving motility of the Roux limb and diversion of duodenal juice from the gastric remnant.

Total Laparoscopic Uncut Roux-en-Y for Radical Distal Gastrectomy: An Interim Analysis of a Randomized, Controlled, Clinical Trial.

Abstract:
The traditional Billroth II and Roux-en-Y anastomosis after laparoscopic distal gastrectomy for gastric cancer are associated with bile reflux gastritis and roux stasis syndrome, respectively. The uncut Roux-en-Y gastrojejunostomy can decrease the incidence of these complications by blocking the entry of bile and pancreatic juice into the residual stomach and retaining the impulses originating from the duodenum. The purpose of the present study was to compare the short-term outcomes of uncut Roux-en-Y (URY) and Billroth II combined Braun (BB) anastomosis.

In this prospective, multi-center, two-arm randomized controlled trial, 124 patients with advanced distal gastric cancer were randomized into two groups: URY (n = 62) and BB (n = 62) groups.

The mean gastric juice pH was significantly lower in the URY group compared with the BB group (3.94 ± 0.71 vs. 5.83 ± 0.91, P < 0.0001). The bile reflux gastritis at 3 months (P < 0.0001) and 6 months (P = 0.002) was significantly more frequent in the BB group. No recanalization occurred in the URY group, and no significant difference was found between the two groups in terms of mean operative time (P = 0.69), mean time to perform anastomosis (P = 0.86), mean estimated blood loss (P = 0.77), mean number of harvested lymph nodes (P = 0.90), time to first passage of flatus or defecation (P = 0.87), postoperative hospital stay (P = 0.83), and the incidence of postoperative complications (P = 0.70).

URY anastomosis is associated with a significantly lower incidence of bile reflux gastritis and roux stasis syndrome compared with BB anastomosis.

Laparoscopic uncut Roux-en-Y for radical distal gastrectomy: the study protocol for a multirandomized controlled trial.

Abstract: Gastric cancer is the third most common cause of cancer-related deaths and is the fifth highest incidence of cancer worldwide, especially in Eastern Asia, Central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, digestive tract reconstruction after distal gastrectomy for gastric cancer is controversial due to the postoperative complications such as reflux gastritis. There is an increasing trend toward laparoscopic uncut Roux-en-Y (URY) for radical gastrectomy. However, evidence on the feasibility of this procedure in patients undergoing laparoscopic radical distal gastrectomy is still absent. Thus, a prospective randomized trial is warranted. This is a prospective, multicenter, two-arm randomized controlled trial in which 210 patients will be randomly assigned to two groups: laparoscopic URY (n=105) and laparoscopic Billroth II plus Braun anastomosis (n=105). Each participant must be pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy at Xijing Hospital and other four hospitals. The laparoscopic URY procedure is based on the Billroth II gastrojejunostomy plus Braun anastomosis, and then blocked the jejunum input loop at the stump-jejunal anastomosis. The patients' demographic and pathological characteristics will be recorded. The total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Postoperative adverse events will also be recorded, as well as at follow-up appointments at three months and six months after surgery. The rate of reflux gastritis will represent the primary endpoint, and other secondary endpoints, which are all recorded.

Tranditional Roux-en-Y vs Uncut Roux-en-Y in Laparoscopic Distal Gastrectomy: a Randomized Controlled Study.

Abstract:
Traditional Roux-en-Y may cause Roux-en-Y stasis syndrome (RSS), and Uncut Roux-en-Y was proposed to solve this problem. However, because afferent loop recanalization may occur after surgery, its clinical application remains controversial. The purpose of this study was to compare the long-term outcomes of these two gastrointestinal reconstruction methods.

A total of 108 patients who received laparoscopic-assisted distal gastrectomy (LADG) were enrolled; 57 were randomly divided into the Uncut Roux-en-Y (URY) group, and 51 were divided into the Roux-en-Y (RY) group. Patients were followed up for 1 year to evaluate variables, including the following: (1) Assessments for RSS; (2) Preoperative and postoperative Gastrointestinal Symptom Rating Scale (GSRS) scores; (3) Postoperative gastroscopy to assess the occurrence of reflux esophagitis (Los Angeles classification), residual gastritis and bile reflux 1 year after surgery; and (4) Upper gastrointestinal radiography to evaluate whether recanalization occurred in patients in the URY group after surgery.

At 1 year after surgery, a total of 42 patients (73.7%) developed afferent loop recanalization. The incidence of RSS was not different between the two groups (OR, 1.301 [95% CI, 0.482 to 3.509]; P = 0.603P = 0.603). The GSRS score was higher in the URY group (P < 0.001). Postoperative gastroscopy showed that the incidence of bile reflux (P < 0.001) and the grade of residual gastritis (P < 0.001) were significantly higher in the URY group, but the grade of reflux esophagitis was not significantly different (P = 0.447, [95% CI, 0.437 to 0.457]P = 0.397).

Compared with traditional Roux-en-Y anastomosis, due to the high recanalization rate, the URY group developed more severe gastrointestinal symptoms, the incidence of bile reflux and the grade of residual gastritis increased and the incidence of postoperative RSS was not reduced.

To cut or not to cut? A prospective randomized controlled trial on short-term outcomes of the uncut Roux-en-Y reconstruction for gastric cancer.

Abstract:
Roux-en-Y (R-Y) anastomoses have been widely used in distal gastrectomy, while the incidence of Roux stasis syndrome remains common. Uncut R-Y anastomosis maintains the neuromuscular continuity, thus avoiding the ectopic pacemaker of the Roux limb and reducing the occurrence of Roux stasis. However, retrospective studies of Uncut R-Y anastomosis remain scarce and randomized controlled trials have not been reported.

We conducted a randomized controlled trial to compare the surgical safety, nutritional status, and postoperative quality of life (QOL) between uncut and classic Roux-en-Y (R-Y) reconstruction patients. Patients with Stage I gastric cancer were randomly enrolled and underwent laparoscopic distal gastrectomy followed by uncut or classic R-Y reconstruction. Body mass index and blood test were used to evaluate the nutritional status. QOL was evaluated using European Organization for Research and Treatment of Cancer QOL Questionnaire (STO22) and laboratory examinations at postoperative month (POM) 3, 6, 9, and 12. Computed tomography scanning was used to evaluate the skeletal muscle index (SMI) at POM 6 and 12. Endoscopy was performed at POM 12.

Operation time, blood loss, time to recovery, complication morbidities, and overall survival were similar between the two groups. Compared with the classic R-Y group, the uncut R-Y group displayed a significantly decreased QOL at POM 9, possibly due to loop recanalization, determined to be occupied 34.2% of the uncut R-Y group. Post-exclusion of recanalization, the QOL was still higher in the classic R-Y group than in the uncut R-Y group, despite their hemoglobin and total protein levels being better than those in the classic R-Y group. Preoperative pre-albumin level and impaired fasting glycemia significantly correlated with the postoperative recanalization.

We found no significant benefit of uncut over classic R-Y reconstruction which challenges the superiority of the uncut R-Y reconstruction.

ClinicalTrials.gov Identifier: NCT02644148.

Randomized controlled trial of uncut Roux-en-Y

Abstract:
To identify which technique is better for avoiding biliary reflux and gastritis between uncut Roux-en-Y and Billroth II reconstruction.

A total of 158 patients who underwent laparoscopy-assisted distal gastrectomy for gastric cancer at the First Hospital of Jilin University (Changchun, China) between February 2015 and February 2016 were randomized into two groups: uncut Roux-en-Y (group U) and Billroth II group (group B). Postoperative complications and relevant clinical data were compared between the two groups.

According to the randomization table, each group included 79 patients. There was no significant difference in postoperative complications between groups U and B (7.6%

Compared with Billroth II reconstruction, uncut Roux-en-Y reconstruction is secure and feasible, and can effectively reduce the incidence of alkaline reflux, residual gastritis, and heartburn. Despite the incidence of recanalization, uncut Roux-en-Y should be widely applied.


Context: Adolescent idiopathic scoliosis (AIS) is a pathology that changes the three-dimensional shape of the spine and trunk. While AIS can progress during growth and cause cosmetic issues, it is usually asymptomatic. However, a final spinal curvature above the critical threshold of 30° increases the risk of health problems and curve progression in adulthood. The use of therapeutic exercises (TEs) to reduce the progression of AIS and delay or avoid other, more invasive treatments is still controversial.

To evaluate the effectiveness of TE, including generic therapeutic exercises (GTE) and physiotherapeutic scoliosis-specific exercises (PSSE) in treating AIS, compared to no treatment, other non-surgical treatments, or between treatments.

Randomised controlled trials (RCTs) comparing TE with no treatment, other non-surgical treatments (braces, electrical stimulation, manual therapy), and different types of exercises. In the previous version of the review, we also included observational studies. We did not include observational studies in this update since we found sufficient RCTs to address our study aims.

Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial.

Abstract:
To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life (HRQL) in patients with mild adolescent idiopathic scoliosis (AIS) (Cobb angle <25°).

This was a parallel-group, randomised, superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction, task-oriented spinal exercises and education (experimental group, 55 subjects) or traditional spinal exercises (control group, 55 subjects). Before treatment, at the end of treatment (analysis at skeletal maturity), and 12 months later (follow-up), all of the patients underwent radiological deformity (Cobb angle), surface deformity (angle of trunk rotation) and HRQL evaluations (SRS-22 questionnaire). A linear mixed model for repeated measures was used for each outcome measure.

There were main effects of time (p < 0.001), group (p < 0.001) and time by group interaction (p < 0.001) on radiological deformity: training in the experimental group led to a significant improvement (decrease in Cobb angle of >5°), whereas the control group remained stable. Analysis of all of the secondary outcome measures revealed significant effects of time, group and time by group interaction in favour of the experimental group.

The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS. The effects lasted for at least 1 year after the intervention ended.

Effect of a preoperative protocol of aerobic physical therapy on the quality of life of patients with adolescent idiopathic scoliosis: a randomized clinical study.

Abstract: Patients with adolescent idiopathic scoliosis (AIS) have lower potential for physical activity because of lung dysfunction and lower muscle strength, which can be reversed by the cardiorespiratory and musculoskeletal conditioning provided by standardized physical activities. We conducted a study to determine if a preoperative protocol of aerobic exercise would improve quality of life (QoL) both before and after training and if there would be any differences between patients who received the therapy and those who did not. Patients with the indication of surgical correction of AIS were randomized to receive or not receive a 4-month preoperative course of aerobic physical training. At baseline and after 4 months, they were evaluated with the Short Form-36 questionnaire (SF-36). QoL scores improved for the study group but did not change for the control group. In all QoL domains, the study group's mean score increased significantly between baseline and 4 months. We concluded that the proposed preoperative physical therapy protocol improved the QoL of patients with AIS.

Effect of Schroth exercises on curve characteristics and clinical outcomes in adolescent idiopathic scoliosis: protocol for a multicentre randomised controlled trial.

Abstract:
The promising results of Schroth scoliosis-specific exercises for adolescent idiopathic scoliosis found in low-quality studies will be strengthened by confirmation in a randomised controlled trial.

1. Are Schroth exercises combined with standard care for 6 months more effective than standard care alone in improving radiographic and clinical outcomes for adolescents with idiopathic scoliosis? 2. Will the outcomes of the control group (who will be offered Schroth therapy delayed by 6 months) improve after 6 months of Schroth therapy? 3. Are the effects maintained 6 months after discontinuing the supervised intervention?

This is an assessor-blinded and statistician-blinded randomised controlled trial with transfer of the controls to the exercise group after 6 months.

Two hundred and fifty-eight consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, treated with or without a brace, with curves between 10 and 45 deg Cobb and Risser sign ≤ 3 will be recruited from three scoliosis clinics.

Combined with standard care, the Schroth group will receive five individual training sessions, followed by weekly group classes and daily home exercises for 6 months.

Controls will only receive standard care consisting of observation or bracing, and will be offered Schroth therapy 6 months later.

Curve severity (Cobb angle) and vertebral rotation will be assessed from radiographs at baseline, 6 and 12 months. Secondary clinical outcomes (back muscle endurance, surface topography measures of posture, and self-reported perceived spinal appearance and quality of life) will be assessed at baseline, and every 3 months until 1-year follow-up.

Data will be analysed using intention-to-treat linear mixed models.

The results will demonstrate whether Schroth exercises combined with standard of care can improve outcomes in adolescents with idiopathic scoliosis. This study has potential to influence clinical practice worldwide, where exercises are not routinely prescribed for adolescents with idiopathic scoliosis.

The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial.

Abstract:
To compare the efficacy of three-dimensional (3D) Schroth exercises in patients with adolescent idiopathic scoliosis.

A randomised-controlled study.

An outpatient exercise-unit and in a home setting.

Fifty-one patients with adolescent idiopathic scoliosis.

Forty-five patients with adolescent idiopathic scoliosis meeting the inclusion criteria were divided into three groups. Schroth's 3D exercises were applied to the first group in the clinic and were given as a home program for the second group; the third group was the control.

Scoliosis angle (Cobb method), angle of rotation (scoliometer), waist asymmetry (waist - elbow distance), maximum hump height of the patients and quality of life (QoL) (SRS-23) were assessed pre-treatment and, at the 6(th), 12(th) and 24(th) weeks.

The Cobb (-2.53°; P=0.003) and rotation angles (-4.23°; P=0.000) significantly decreased, which indicated an improvement in the clinic exercise group compared to the other groups. The gibbosity (-68.66mm; P=0.000) and waist asymmetry improved only in the clinic exercise group, whereas the results of the other groups worsened. QoL did not change significantly in either group.

According to the results of this study the Schroth exercise program applied in the clinic under physiotherapist supervision was superior to the home exercise and control groups; additionally, we observed that scoliosis progressed in the control group, which received no treatment.

The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

Abstract:
In North America, care recommendations for adolescents with small idiopathic scoliosis (AIS) curves include observation or bracing. Schroth scoliosis-specific exercises have demonstrated promising results on various outcomes in uncontrolled studies. This randomized controlled trial (RCT) aimed to determine the effect of Schroth exercises combined with the standard of care on quality-of-life (QOL) outcomes and back muscle endurance (BME) compared to standard of care alone in patients with AIS.

Fifty patients with AIS, aged 10-18 years, with curves 10-45 °, recruited from a scoliosis clinic were randomized to receive standard of care or supervised Schroth exercises plus standard of care for 6 months. Schroth exercises were taught over five sessions in the first two weeks. A daily home program was adjusted during weekly supervised sessions. The assessor and the statistician were blinded. Outcomes included the Biering-Sorensen (BME) test, Scoliosis Research Society (SRS-22r) and Spinal Appearance Questionnaires (SAQ) scores. Intention-to-treat (ITT) and per protocol (PP) linear mixed effects models were analyzed. Because ITT and PP analyses produced similar results, only ITT is reported.

After 3 months, BME in the Schroth group improved by 32.3 s, and in the control by 4.8 s. This 27.5 s difference in change between groups was statically significant (95 % CI 1.1 to 53.8 s, p = 0.04). From 3 to 6 months, the self-image improved in the Schroth group by 0.13 and deteriorated in the control by 0.17 (0.3, 95 % CI 0.01 to 0.59, p = 0.049). A difference between groups for the change in the SRS-22r pain score transformed to its power of four was observed from 3 to 6 months (85.3, 95 % CI 8.1 to 162.5, p = 0.03), where (SRS-22 pain score)(4) increased by 65.3 in the Schroth and decreased by 20.0 in the control group. Covariates: age, self-efficacy, brace-wear, Schroth classification, and height had significant main effects on some outcomes. Baseline ceiling effects were high: SRS-22r (pain = 18.4 %, function = 28.6 %), and SAQ (prominence = 26.5 %, waist = 29.2 %, chest = 46.9 %, trunk shift = 12.2 % and shoulders = 18.4 %).

Supervised Schroth exercises provided added benefit to the standard of care by improving SRS-22r pain, self-image scores and BME. Given the high prevalence of ceiling effects on SRS-22r and SAQ questionnaires' domains, we hypothesize that in the AIS population receiving conservative treatments, different QOL questionnaires with adequate responsiveness are needed.

Schroth Exercise Trial for Scoliosis NCT01610908.

Effects of Schroth and Pilates exercises on the Cobb angle and weight distribution of patients with scoliosis.

Abstract: [Purpose] The purpose of this study was to compare the effect of Schroth and Pilates exercises on the Cobb angle and body weight distribution of patients with idiopathic scoliosis. [Subjects] Twenty-four scoliosis patients with a Cobb angle of ≥20° were divided into the Schroth exercise group (SEG, n = 12) and the Pilates exercise group (PEG, n = 12). [Methods] The SEG and PEG performed Schroth and Pilates exercises, respectively, three times a week for 12 weeks. The Cobb angle was measured in the standing position with a radiography apparatus, and weight load was measured with Gait View Pro 1.0. [Results] In the intragroup comparison, both groups showed significant changes in the Cobb angle. For weight distribution, the SEG showed significant differences in the total weight between the concave and convex sides, but the PEG did not show significant differences. Furthermore, in the intragroup comparison, the SEG showed significant differences in the changes in the Cobb angle and weight distribution compared with the PEG. [Conclusion] Both Schroth and Pilates exercises were effective in changing the Cobb angle and weight distribution of scoliosis patients; however, the intergroup comparison showed that the Schroth exercise was more effective than the Pilates exercise.

Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

Abstract:
The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.

To determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group) on the Cobb angle compared to standard of care alone (Control group) in patients with AIS.

Fifty patients with AIS aged 10-18 years, with curves of 10°-45° and Risser grade 0-5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30-45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported.

In the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006). Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046), suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002) and [Formula: see text] (95% CI -0.8 to 0.2, p = 0.006).

Schroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS.

NCT01610908.

[Effect of asymmetric respiratory exercise therapy on respiratory system function; evaluation using spirometric examination in children with idiopathic scoliosis].

Abstract: Current work presents the results of spirometric examinations in 124 children aged 5 to 16 years (mean age 12.1 years) suffering from idiopathic scoliosis. Children were treated according to asymmetric respiratory exercises method applied in period of 24 days. Healthy children living in Upper Silesia industrial region were the control group. Examined scoliotic group was characterized by generally mild lung function impairment, although the values of spirometric indexes tended to deplete with time of duration and severity of the scoliosis. Especially the tendency of the forced expiratory volume in first second (FEV1) decrease was apparent, as well as maximal expiratory flows MEF50 and MEF25, in conjunction with Cobb angle increase. Slight but evident increase of forced vital capacity (FVC) and FEV1 was observed as a result of rehabilitation utilizing asymmetric respiratory exercises method.

The role of measured resistance exercises in adolescent scoliosis.

Abstract: Twenty adolescent patients (18 girls and 2 boys) with scoliosis ranging from 15 degrees-41 degrees in their major curve were treated with a progressive resistive training program for torso rotation. All patients demonstrated an asymmetry of rotation strength measured on specialized equipment, and surface electrode electromyograms showed inhibition of lumbar paraspinal muscles. Sixteen of 20 patients demonstrated curve reduction, and no patient showed an increase in curve.

Incidence of curvature progression in idiopathic scoliosis patients treated with scoliosis in-patient rehabilitation (SIR): an age- and sex-matched controlled study.

Abstract: The goal of this study is to test the hypothesis that physiotherapy-based intervention can reduce incidence of progression in children with IS. Two independent patient groups matched by age and sex at diagnosis were analysed using the outcome parameter, incidence of progression (> or =5 degrees ). One group was untreated and the other received scoliosis in-patient rehabilitation (SIR). Incidence of progression in groups of untreated patients ranged from 1.5-fold (71.2% vs 46.7%) to 2.9-fold (55.8% vs 19.2%) higher than in groups of patients treated with SIR, even when SIR-treated groups included patients with more severe curvatures. Statistically, the differences were highly significant. Efforts to test the hypothesis that physical therapies addressing postural imbalance can be used effectively in the treatment of IS have been limited. The results of this study are consistent with the possibility that a supervized programme of exercise-based therapies can reduce incidence of progression in children with IS.


Context: Oral submucous fibrosis (OSF) is a chronic disease of the oral cavity that causes progressive constriction of the cheeks and mouth accompanied by severe pain and reduced mouth opening. OSF has a significant impact on eating and swallowing, affecting quality of life. There is an increased risk of oral malignancy in people with OSF. The main risk factor for OSF is areca nut chewing, and the mainstay of treatment has been behavioural interventions to support habit cessation. This review is an update of a version last published in 2008.

To evaluate the benefits and harms of interventions for the management of oral submucous fibrosis.

We considered randomised controlled trials (RCTs) of adults with a biopsy-confirmed diagnosis of OSF treated with systemic, locally delivered or topical drugs at any dosage, duration or delivery method compared against placebo or each other. We considered surgical procedures compared against other treatments or no active intervention. We also considered other interventions such as physiotherapy, ultrasound or alternative therapies.

Pentoxifylline therapy: a new adjunct in the treatment of oral submucous fibrosis.

Abstract:
This study was designed to determine the effect of pentoxifylline (Trental) on the clinical and pathologic course of oral submucous fibrosis. This drug is a methylxanthine derivative that has vasodilating properties and was envisaged to increase mucosal vascularity.

This investigation was conducted as a randomized clinical trial incorporating a control group (Standard drug group SDG, multivitamin, and local heat therapy) in comparison to pentoxifylline test cases (Experimental drug group EDG, 400mg 3 times daily, as coated, sustained release tablets). The stipulated treatment period was 7 months and a total of 29 cases of advanced fibrosis (14 test subjects and 15 age and sex matched diseased controls) were included in this study and 100% compliance was reported at the end ofthe test period.

Mild gastric irritation that could be managed by diet protocols was the only untoward symptom reported during this trial. Review of the patients and controls was done at an interval of 30 days and subjective and objective measurements were recorded. The follow up data at each visit with respect to each other and to base-line values was calibrated using a nonparametric test of Mann-Whitney (Kruskal-Wallis test). Significant comparisons with regard to improvement were recorded as objective criteria of mouth opening (t=11.285, p= 0.000), tongue protrusion (t= 3.898, p = 0.002), and relief from perioral fibrotic bands (p = 0.0001554). Subjective symptoms of intolerance to spices (p = 0.0063218), burning sensation of mouth (p = 0.0005797), tinnitus (p=0.000042), difficulty in swallowing (p=0.0000714). and difficulty in speech (p=0.0000020) were also recorded significant improvement at the end of the trial period.

This pilot investigation points to the effectiveness of pentoxifylline as an adjunct therapy in the routine management of oral submucous fibrosis.

Efficacy of lycopene in the management of oral submucous fibrosis.

Abstract:
To evaluate the efficacy of oral lycopene therapy in patients with oral submucous fibrosis and to compare these effects with a placebo.

Fifty-eight patients with oral submucous fibrosis formed the population for the study and were randomly divided into 3 groups, evaluated weekly over a 2-month period. Patients of group A (n = 21) received 16 mg of lycopene, those of group B (n = 19) received 16 mg of lycopene along with biweekly intralesional steroid injections, and those of group C (n = 18) were given a placebo. Paired and unpaired t tests were used for statistical evaluation.

Mouth-opening values for the patients showed an average increase of 3.4 mm, 4.6 mm, and 0.0 mm for patients in groups A, B, and C, respectively. These values were statistically found to be highly significant.

The observed effects suggest that lycopene can and should be used as a first line of therapy in the initial management of oral submucous fibrosis.

Physiotherapeutic treatment improves oral opening in oral submucous fibrosis.

Abstract:
In oral submucous fibrosis (OSF) fibrous bands and burning mucosal pain restrict oral opening to limit speech and eating. The pathogenesis of OSF remains unclear, while surgical and pharmacological treatments have limited success, and are often inaccessible in communities using areca nut where OSF is prevalent. Improved outcomes are reported for surgical treatment when followed by physiotherapy. We tested the hypothesis that physiotherapy alone can modify tissue remodelling in OSF to increase oral opening.

Fifty-four Nepali OSF patients were managed for 4 months in three randomly assigned groups receiving either: five times daily physiotherapy by inter-positioning tongue spatulas between teeth and adding a new spatula every 5-10 days; local injection of hyaluronidase with steroids; or no active treatment.

More males presented with OSF than females (p < 0.05). All patients reported reduced opening and 47% had mucosal pain. Progressive mucosal involvement was always in the same order, starting with the soft palate, and then progressing to the fauces, unilateral buccal mucosa, bilateral buccal mucosa, floor of mouth and finally lip mucosa (p < 0.006). Physiotherapy improved oral opening (p < 0.0005), but not oral pain, while no clear improvement was seen in untreated patients as well as patients managed by injection.

We conclude OSF in the Nepali population progresses in a predictable pattern, and that physiotherapy is effective for increasing the oral opening. We further suggest physiotherapy can be readily used to improve OSF in communities with otherwise limited health resources.

Oral administration of milk from cows immunized with human intestinal bacteria leads to significant improvements of symptoms and signs in patients with oral submucous fibrosis.

Abstract:
Previous studies have shown that the local and systemic upregulation of fibrogenic cytokines and downregulation of antifibrotic cytokine are central to the pathogenesis of oral submucous fibrosis (OSF). The milk from cows immunized with human intestinal bacteria (immune milk) contains an anti-inflammatory component that may suppress the inflammatory reaction and modulate cytokine production. Therefore, it was decided to test whether immune milk may have some beneficial effects on controlling the symptoms and signs in OSF patients.

In this preliminary study, 26 OSF patients who received immune milk treatment (45 g of immune milk powder twice a day) for 3 months and oral habit intervention were included in the experimental group. Another 20 OSF patients who received only oral habit intervention served as the control group.

We found that the interincisor distance was significantly improved (> or =3 mm of the baseline measurement) in 18 of the 26 (69.2%) OSF patients in the experimental group at exit. However, in the control group none of the OSF patients had an increase in interincisor distance greater than 2 mm. In addition, disappearance or significant improvement of symptoms at exit was observed in 80% (16/20) of the patients with intolerance to spicy foods (P < 0.001) and 72.2% (13/18) of the patients with xerostomia (P < 0.005) in the experimental group, compared with 17.6% (3/17) of the patients with improvement of intolerance to spicy foods and 15.4% (2/13) of the patients with improvement of xerostomia in the control group. Partial regression of concomitant oral leukoplakia or erythroplakia (judged from the size reduction of the lesions) at exit was noted in 71.4% (5/7) of the patients in the experimental group (P < 0.05), compared with none (0/5) of the patients with improvement in the control group.

We conclude that oral administration of immune milk leads to significant improvements of symptoms and signs in OSF patients.

Extended nasolabial flaps in the management of oral submucous fibrosis.

Abstract: We evaluated the use of extended nasolabial flaps and coronoidectomy in the management of 47 randomly selected patients with histologically confirmed oral submucous fibrosis. They all had interincisal opening of less than 25 mm and were treated by bilateral release of fibrous bands, coronoidectomy or coronoidotomy, and extended grafting with a nasolabial flap. All patients had postoperative physiotherapy, and were followed up for 2 years. Their interincisal opening improved significantly from a mean of 14 mm (range 3-23) to a mean of 41 mm (range 23-55). The procedure was effective in the management of patients with oral submucous fibrosis, the main disadvantage being the extraoral scars.

Retrospective comparison of surgical treatment modalities in 100 patients with oral submucous fibrosis.

Abstract:
Oral submucous fibrosis has been a scourge of southeastern Asia and its residents since time immemorial. Scores of medicinal agents, singly and in combination, have been tried with not very encouraging results. In this study, therefore, we have restricted ourselves to different surgical modalities in the management of this condition and have tried to lay down indications of each surgical procedure.

A total of 100 patients of oral submucous fibrosis were included in this study and randomly allocated to different surgical groups, 25 patients per group. After excision of fibrous bands, group I had buccal fat pad graft, group II had tongue flap, group III had nasolabial fold flap, and group IV had split skin graft for correction of mucosal defect created after incising the fibrous bands.

Mean preoperative mouth opening was 14.82 (SD 4.38) mm and ranged between 4.00 and 25.00 mm. Statistically there was no significant difference among the 4 groups (P = .996). Mean postoperative mouth opening at 1 week was 35.79 (3.53) mm, ranging between 24.00 and 42.00 mm. Mean postoperative mouth opening at 1 month in group I was 36.36 (2.64) mm, in group II 35.36 (29) mm, in group III 35.64 (2.94) mm, and in group IV 35.80 (3.24) mm. Total score for pain, esthetics, and function at 1 month after surgery was highest (11.29) in group I, indicating better results.

The results were very encouraging, and we were able to lay down specific indications for each procedure. However, we believe buccal fat pad rotation is superior to other procedures, because it offers ease of surgery, can be performed under local anesthesia as a day care procedure, shows little postoperative morbidity, and has good patient acceptance, and there appear to be no contraindications to its use.

Lack of reliable evidence for oral submucous fibrosis treatments.

Abstract:
Searches were made for relevant studies using the Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase and IndMED (bibliographic database of Indian biomedical journals). There were no language restrictions.

Randomised controlled trials were to be selected if they compared surgery, systemic or topical medicines, or other interventions, to manage the symptoms of oral submucous fibrosis (OSF).

Two authors independently assessed trial quality and extracted trial data. Disagreements were resolved by consultation with a third author. Attempts were made to contact study authors where necessary for clarification and for additional information. Because of limited poor quality data, only a descriptive summary of the results of the included trials was carried out.

Two trials, involving 87 participants, evaluated either lycopene in conjunction with intralesional injections of a steroid, and pentoxifylline in combination with mouth-stretching exercises and heat. There were no reports of toxicity to the interventions but some side-effects, which were mostly gastric irritation to pentoxifylline, were noted.

The lack of reliable evidence for the effectiveness of any specific interventions for the management of OSF is illustrated by the paucity, and poor methodological quality, of trials retrieved for this review.

Drug treatment of oral submucous fibrosis: a review of the literature.

Abstract:
To review the literature on drug treatment of oral submucous fibrosis.

An electronic search was performed for articles published from January 1960 to August 2008.

Only 17 publications were searched, and 15 publications showed a high level of evidence (6 randomized controlled trials, 4 clinical trials/controlled clinical trials, and 5 other experimental studies), with a total of 1,224 patients.

Few studies with high levels of evidence were found. It is quite difficult to compare or even combine their outcomes in a scientifically meaningful manner. Because of insufficient research data, there is a need for high-quality randomized, controlled trials in this area of medicine.

A systematic review of medical interventions for oral submucous fibrosis and future research opportunities.

Abstract: Oral Diseases (2011) 17 (Suppl. 1), 42-57 Oral submucous fibrosis (OSF) is a chronic, insidious disease caused by areca nut use, and is associated with both significant morbidity (including pain and reduced oral opening) and an increased risk for malignancy. This systematic review explored and updated the current medical (i.e., non-surgical) interventions available for the management of OSF. Of the 27 published medical interventions, there were four randomized controlled trials. The overall quality of these randomized controlled studies was assessed using the GRADE approach and significant limitations that challenged the conclusions were found. However, this review was valuable in terms of identifying opportunities to provide recommendations for future research, in terms of the populations to research, the types of interventions needed, the types of outcomes to be measured, the study designs needed, and the infrastructure required to conduct studies. The next step is to initiate a pathway for a low-cost research plan leading to the development of a brief protocol for future clinical trials in this field, with an emphasis on conducting studies in regions of the world where OSF is prevalent.

Use of buccal fat pad for treatment of oral submucous fibrosis.

Abstract:
The aim of this study was to clinically evaluate the application of pedicled buccal fat pad (BFP) in the surgical management of stage III and IV oral submucous fibrosis (OSMF).

Twenty-eight cases of clinically and histologically diagnosed cases of OSMF were divided into 2 groups: group I (n = 15) and group II (n = 13), corresponding to clinical stage III and stage IV, respectively. All the patients underwent incision of fibrotic bands and coverage of the buccal defect with a pedicled BFP flap. Both groups were analyzed separately for mouth opening (interincisal distance in millimeters) preoperatively and 1 year postoperatively, time taken for epithelialization of BFP, time taken for establishment of normal contour, and changes in symptoms (painful ulcerations, burning sensation, and intolerance to spices) 1 year after grafting.

The mean preoperative mouth opening was 19.6 mm (SD, 2.43) in group I and 12.92 mm (SD, 1.21) in group II. The mean postoperative mouth opening after 1 year was 35 mm in group I (SD, 1.96) and 31.76 mm in group II (SD, 1.97). The time taken for epithelialization of BFP was 4 weeks in group I and 5 weeks in group II. The mean time taken for establishment of normal contour after grafting was 12.25 weeks (SD, 1.42) in group I and 15.07 weeks (SD, 1.26) in group II. In 2 cases in group II, there was remission of painful ulcerations, burning sensation, and intolerance to spices.

BFP is reliable for the treatment of OSMF.


Context: Massage is widely used for neck pain, but its effectiveness remains unclear.

To assess the benefits and harms of massage compared to placebo or sham, no treatment or exercise as an adjuvant to the same co-intervention for acute to chronic persisting neck pain in adults with or without radiculopathy, including whiplash-associated disorders and cervicogenic headache.

We included randomised controlled trials (RCTs) comparing any type of massage with sham or placebo, no treatment or wait-list, or massage as an adjuvant treatment, in adults with acute, subacute or chronic neck pain.

Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain.

Abstract:
To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain.

Prospective, randomised, placebo controlled trial.

Three outpatient departments in Germany.

177 patients aged 18-85 years with chronic neck pain.

Patients were randomly allocated to five treatments over three weeks with acupuncture (56), massage (60), or "sham" laser acupuncture (61).

maximum pain related to motion (visual analogue scale) irrespective of direction of movement one week after treatment.

range of motion (3D ultrasound real time motion analyser), pain related to movement in six directions (visual analogue scale), pressure pain threshold (pressure algometer), changes of spontaneous pain, motion related pain, global complaints (seven point scale), and quality of life (SF-36). Assessments were performed before, during, and one week and three months after treatment. Patients' beliefs in treatment were assessed.

One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052) but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years (n=75) and in patients with myofascial pain syndrome (n=129). The acupuncture group had the best results in most secondary outcome measures. There were no differences in patients' beliefs in treatment.

Acupuncture is an effective short term treatment for patients with chronic neck pain, but there is only limited evidence for long term effects after five treatments.

Immediate effects of inhibitive distraction on active range of cervical flexion in patients with neck pain: a pilot study.

Abstract: The purpose of this pilot study was to examine the immediate effects of a manual therapy technique called Inhibitive Distraction (ID) on active range of motion (AROM) for cervical flexion in patients with neck pain with or without concomitant headache. A secondary objective of this study was to see whether patient subgroups could be identified who might benefit more from ID by studying variables such as age, pain intensity, presence of headache, or pre-intervention AROM. We also looked at patients' ability to identify pre- to post-intervention changes in their ability to actively move through a range of motion. Forty subjects (mean age 34.7 years; range 16-48 years) referred to a physical therapy clinic due to discomfort in the neck region were randomly assigned to an experimental and a control group. We used the CROM goniometer to measure pre- and post-intervention cervical flexion AROM in the sagittal plane within a single treatment session. The between-group difference in AROM increase was not statistically significant at P<0.05 with a mean post-intervention increase in ROM of 2.4 degrees (SD 6.2 degrees ) for the experimental group and 1.2 degrees (SD 5.8 degrees ) for the placebo group. We were also unable to identify potential subgroups more likely to respond to ID, although a trend emerged for greater improvement in chronic patients with headaches, lower pain levels, and less pre-intervention AROM. In the experimental group and in both groups combined, subjects noting increased AROM indeed had a significantly greater increase in AROM than those subjects not noting improvement. In conclusion, this study did not confirm immediate effects of ID on cervical flexion AROM but did provide indications for potential subgroups likely to benefit from this technique. Recommendations are provided with regard to future research and clinical use of the technique studied.

Comparative effects of acupressure at local and distal acupuncture points on pain conditions and autonomic function in females with chronic neck pain.

Abstract: Acupressure on local and distal acupuncture points might result in sedation and relaxation, thereby reducing chronic neck pain. The aim was to investigate the effect of acupressure at local (LP) and distal acupuncture points (DP) in females with chronic neck pain. Thirty-three females were assigned to three groups: the control group did not receive any stimuli, the LP group received acupressure at local acupuncture points, GB 21, SI 14 and SI 15, and the DP group received acupressure at distal acupuncture points, LI 4, LI 10 and LI 11. Verbal rating scale (VRS), Neck Disability Index (NDI), State-Trait Anxiety Inventory (STAI), muscle hardness (MH), salivary alpha-amylase (sAA) activity, heart rate (HR), heart rate variability (HRV) values and satisfaction due to acupressure were assessed. VRS, NDI, STAI and MH values decreased after acupressure in the LP and the DP group. HR decreased and the power of high frequency (HF) component of HRV increased after acupressure in only the LP group. Although acupressure on not only the LP but also the DP significantly improved pain conditions, acupressure on only the LP affected the autonomic nervous system while acupuncture points per se have different physical effects according to location.

The efficacy of an integrated neuromuscular inhibition technique on upper trapezius trigger points in subjects with non-specific neck pain: a randomized controlled trial.

Abstract: Currently, large levels of practice variability exist regarding the clinical deactivation of trigger points. Manual physical therapy has been identified as a potential means of resolving active trigger points; however, to date the ideal treatment approach has yet to be elucidated. The purpose of this clinical trial was to compare the effects of two manual treatment regimens on individuals with upper trapezius trigger points. Sixty patients, 19-38 years of age with non-specific neck pain and upper trapezius trigger points, were randomized into one of two, 4 week physical therapy programs. One group received muscle energy techniques while the second group received an integrated neuromuscular inhibition technique (INIT) consisting of muscle energy techniques, ischemic compression, and strain-counterstrain (SCS). Outcomes including a visual analog pain scale (VAS), the neck disability index (NDI), and lateral cervical flexion range of motion (ROM) were collected at baseline, 2 and 4 weeks after the initiation of therapy. Results revealed large pre-post-effect sizes within the INIT group (Cohen's d  =  0.97, 0.94 and 0.97). Additionally, significantly greater improvements in pain and neck disability and lateral cervical flexion ROM were detected in favor of the INIT group (0.29-0.57, 0.57-1.12 and 0.29-0.57) at a 95% CI respectively. The findings of this study indicate the potential benefit of an integrated approach in deactivating upper trapezius trigger points. Further research should be performed to investigate the long-term benefits of the current treatment approach.

Strain-counterstrain to treat restrictions of the mobility of the cervical spine in patients with neck pain: a sham-controlled randomized trial.

Abstract:
Strain-counterstrain is an osteopathic technique which is widely used for treating mobility restrictions in the neck. We aimed to investigate whether a single strain-counterstrain intervention is more effective than a sham intervention in improving restricted cervical range of motion in patients with neck pain.

61 adult patients with neck pain and restricted cervical mobility were randomly allocated to receive either a single strain-counterstrain intervention or a sham treatment. After outcome measurement all patients received full individualized osteopathic treatment. Mobility of the cervical spine was measured by a blinded observer using the Cervical Range of Motion (CROM) tool. In addition, patients rated pain intensity and assessed the treatment effect. The main outcome measure was the sum of changes in mobility restriction (in %) after treatment compared to normal mobility.

All patients completed the study. Mobility restriction decreased by 2.0% (SD 6.9%) in the group receiving strain-counterstrain treatment and 0.6% (SD 5.7%) in the group receiving sham treatment (mean difference 1.5%, 95% confidence interval -1.7 to 4.8%; p=0.35). There were no significant differences between groups for secondary outcomes. After receiving the full osteopathic treatment the group initially receiving strain-counterstrain improved by another 4.2% (7.0%; p=0.003) and the group initially receiving sham by another 5.6% (SD 6.8%; p<0.001).

Strain-counterstrain as a single intervention did not have immediate effects on mobility and pain over a sham treatment. Future studies should probably focus on the investigation of full osteopathic treatment.

Short-term changes in median nerve neural tension after a suboccipital muscle inhibition technique in subjects with cervical whiplash: a randomised controlled trial.

Abstract:
To assess the immediate effect of a suboccipital muscle inhibition (SMI) technique on: (a) neck pain, (b) elbow extension range of motion during the upper limb neurodynamic test of the median nerve (ULNT-1), and (c) grip strength in subjects with cervical whiplash; and determine the relationships between key variables.

Randomised, single-blind, controlled clinical trial.

Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Spain.

Forty subjects {mean age 34 years [standard deviation (SD) 3.6]} with Grade I or II cervical whiplash and a positive response to the ULNT-1 were recruited and distributed into two study groups: intervention group (IG) (n=20) and control group (CG) (n=20).

The IG underwent the SMI technique for 4minutes and the CG received a sham (placebo) intervention. Measures were collected immediately after the intervention.

The primary outcome was elbow range of motion during the ULNT-1, measured with a goniometer. The secondary outcomes were self-perceived neck pain (visual analogue scale) and free-pain grip strength, measured with a digital dynamometer.

The mean baseline elbow range of motion was 116.0° (SD 10.2) for the CG and 130.1° (SD 7.8) for the IG. The within-group comparison found a significant difference in elbow range of motion for the IG [mean difference -15.4°, 95% confidence interval (CI) -20.1 to -10.6; P=0.01], but not for the CG (mean difference -4.9°, 95% CI -11.8 to 2.0; P=0.15). In the between-group comparison, the difference in elbow range of motion was significant (mean difference -10.5°, 95% CI -18.6 to -2.3; P=0.013), but the differences in grip strength (P=0.06) and neck pain (P=0.38) were not significant.

The SMI technique has an immediate positive effect on elbow extension in the ULNT-1. No immediate effects on self-perceived cervical pain or grip strength were observed.

Five-week outcomes from a dosing trial of therapeutic massage for chronic neck pain.

Abstract:
This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain.

We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group.

After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively).

After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes.

Abstract:
This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments.

The aim was to determine the optimal dose of massage for neck pain.

Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage.

A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included.

Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline.

Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs.

There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups.

"Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.

Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial.

Abstract: This study was planned to assess and compare the effectiveness of cervical and scapulothoracic stabilization exercise treatment with and without connective tissue massage (CTM) on pain, anxiety, and the quality of life in patients with chronic mechanical neck pain (MNP). Sixty patients with chronic MNP (18-65 years) were recruited and randomly allocated into stabilization exercise with (Group 1, n = 30) and without the CTM (Group 2, n = 30). The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer (JTech Medical Industries, ZEVEX Company), level of anxiety with Spielberger State Trait Anxiety Inventory, and quality of life with Short Form-36 were evaluated before and after the treatment. After the program, pain intensity and the level of anxiety decrease, physical health increase in Group 1 and 2 were found (p < 0.05). Pressure pain threshold and mental health increase were detected in only Group 1 (p < 0.05). The intergroup comparison showed that significant difference in pain intensity at night, pressure pain threshold, state anxiety and mental health were seen in favor of Group 1 (p < 0.05). The study suggested that stabilization exercises with and without the CTM might be a useful treatment for patients with chronic MNP. However, stabilization exercises with CTM might be superior in improving pain intensity at night, pressure pain threshold, state anxiety and mental health compared to stabilization exercise alone.

Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial.

Abstract:
With growing evidence for the effectiveness of craniosacral therapy (CST) for pain management, the efficacy of CST remains unclear. This study therefore aimed at investigating CST in comparison with sham treatment in chronic nonspecific neck pain patients.

A total of 54 blinded patients were randomized into either 8 weekly units of CST or light-touch sham treatment. Outcomes were assessed before and after treatment (week 8) and again 3 months later (week 20). The primary outcome was the pain intensity on a visual analog scale at week 8; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients' global impression of improvement, and safety.

In comparison with sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 (-21 mm group difference; 95% confidence interval, -32.6 to -9.4; P=0.001; d=1.02) and at week 20 (-16.8 mm group difference; 95% confidence interval, -27.5 to -6.1; P=0.003; d=0.88). Minimal clinically important differences in pain intensity at week 20 were reported by 78% within the CST group, whereas 48% even had substantial clinical benefit. Significant between-group differences at week 20 were also found for pain on movement, functional disability, physical quality of life, anxiety and patients' global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8. No serious adverse events were reported.

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.