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Competing interests {28}
The authors declare that they have no competing interests.
PMC10566182
References
PMC10566182
Background
neck pain, pain
Action observation (AO) has emerged as a potential neurorehabilitation therapy for patients with neck pain (NP), but evidence of its effectiveness is scarce. This study aims to assess the effect of a single session of AO when compared to observing a natural landscape on NP intensity, fear of movement, fear-avoidance be...
PMC10729350
Methods
pain
Sixty participants with NP were randomly allocated to the AO group (n = 30) or control group (n = 30). Both groups watched an 11-minute video: the AO group watched a video of a person matched for age and sex performing neck exercises, while the control group watched a video of natural landscapes. Neck pain intensity, f...
PMC10729350
Results
pain
There was a significant main effect of time for pain intensity (p = 0.02; η2p = 0.09; within-group mean change and 95% CI: AO=-1.44 (-2.28, -0.59); control=-1.90 (-2.74, -1.06), but no time versus group interaction (p = 0.46). A time versus group significant interaction was found for one out of the six measurement site...
PMC10729350
Conclusions
hypoalgesia, pain
Results suggest a similar acute benefit for both a single session of AO and observing natural landscapes for promoting hypoalgesia, but no impact on kinesiophobia, fear-avoidance beliefs, or pressure pain thresholds. Also, AO had no positive effect on two-point discrimination and muscle strength. Further research is ne...
PMC10729350
Trial registration
Clinialtrials.gov (NCT05078489).
PMC10729350
Keywords
PMC10729350
Background
chronic idiopathic NP (secondary aim)., AO, disability, pain
Neck pain (NP) was documented among the worldwide leading causes of years lived with disability as the fourth leading cause of disability-adjusted life years [More recently, interventions targeting the central nervous system instead of the peripheral tissues, such as those requiring mental practice or observation of mo...
PMC10729350
Methods
PMC10729350
Study design, ethics approval, and registration
This study was a randomized controlled trial with two groups (the AO group and the control group). It was approved by the Ethics Committee of the University of Aveiro (21-CED/2020). All participants signed an informed consent before entering the study. Before the enrollment of the first participant, the study was regis...
PMC10729350
Procedures
PMC10729350
Randomization and allocation concealment
The participants were randomly assigned to the AO group and the control group through a computerized random list generator (
PMC10729350
Instruments and procedures
pain
BLIND
Participants were assessed for age, gender, number of years of formal education, weight, height, and pain duration at baseline. In addition, participants were assessed for pain intensity and frequency, disability, catastrophizing, fear of movement, fear-avoidance beliefs, tactile acuity, and pressure pain threshold, bo...
PMC10729350
Pain intensity, duration, and frequency
neck pain, Pain, pain
Pain intensity at the moment was assessed using a 10-cm Visual Analogue Scale (VAS), anchored “no pain at all” and “worst pain imaginable” [NP duration and frequency were determined with closed questions (pain duration: “For how long have you had pain in the neck region?”; response options: i) between 3 and 6 months; i...
PMC10729350
Neck disability index
Disability
Disability was assessed using the Neck Disability Index (NDI). This instrument was originally developed by Vernon and Mior [
PMC10729350
Pain catastrophizing scale
Pain
Pain catastrophizing was assessed using the Portuguese version of the Pain Catastrophizing Scale (PCS). The PCS is a 13-item scale with three subscales and participants are instructed to recall past painful experiences and to indicate to what level they have experienced each on a 5-point Likert scale: 0 (not at all) to...
PMC10729350
Tampa scale of kinesiophobia
Fear of movement was assessed with the 13-item Portuguese version of the Tampa Scale for Kinesiophobia (TSK) [
PMC10729350
Fear-avoidance beliefs questionnaire
Fear-avoidance beliefs were assessed with the Portuguese version of the 16 items Fear-Avoidance Beliefs Questionnaire (FABQ), originally developed by Waddell et al. [
PMC10729350
Tactile acuity
Tactile acuity was assessed with the two-point discrimination (TPD) test using an aesthesiometer (Baseline Two-Point Aesthesiometer). This test assesses the ability of the individual to precisely perceive the location and quality of touch, which is assumed as an indirect measure of cortical reorganization [
PMC10729350
Neck muscle strength
craniocervical flexion
WEST, CONTRACTION, CONTRACTIONS
Neck muscle strength was assessed with a hand-held dynamometer (Advanced Force Gauge, 2500 N; Mecmesin, West Sussex, UK). Participants were briefed about the procedure and went through a trial in the limbs for familiarization. Before the neck muscles assessment, participants performed warm-up exercises by doing 10 acti...
PMC10729350
Pressure pain threshold
pain
Pressure pain threshold (PPT) was measured with an electronic pressure algometer (JTECH Medical Industries, Salt Lake City, US) at the right and left upper trapezius muscles (at the middle distance between the posterior angle of the acromion and C7), at the right and left articular pillar between C1 and C2 (1 cm latera...
PMC10729350
Training of the assessors
Prior to the study, the assessors underwent a three-stage training procedure: (i) a three-hour session of training with a senior researcher, (ii) data collection in at least three participants who did not enter the final sample size, and (iii) a final session to clarify any doubts and difficulties from implementing the...
PMC10729350
Intervention and control
Participants in both groups were instructed to sit on a comfortable chair in a quiet, empty room with white walls in front of a laptop (Fig.  Setting of the intervention
PMC10729350
Action observation
craniocervical flexion
Participants were asked to observe video clips of a person performing two different exercises of craniocervical flexion (Fig.  Neck exercises.
PMC10729350
Control
Participants in this group observed a video that displayed natural scenes with no human movement stimuli, similar to other previous studies [ Natural landscapes
PMC10729350
Statistical analysis
All data analyses were performed using Statistical Package for Social Science (SPSS) 25.0 for Windows (SPSS Inc, Chicago, IL). Mean and standard deviation (SD) and count and proportion were used to describe continuous and categorical variables, respectively. Data were assessed for outliers, normality using Kolmogorov-S...
PMC10729350
Results
Of 107 individuals screened for eligibility, 24 were excluded because they did not meet the inclusion criteria, one was unable to assume the testing positions, 22 declined to participate and 60 entered the study (30 individuals in each group). The flow of participants is represented in Fig.  Flowchart of study particip...
PMC10729350
Sample characteristics
Pain
The AO group consisted of 24 females (80%) and 6 (20%) males, and the control group had 22 (73.3%) females and 8 (26.7%) males. The mean age (± SD) in the AO group was 37.4 (± 9.9) years old, and in the control group was 42.3 (± 10.2) years old (see Table  Sociodemographic characteristicsUndergraduate EducationMaster’s...
PMC10729350
Post-intervention assessment
PMC10729350
Neck pain intensity
Pain, pain
There was a significant decrease in pain intensity from baseline to post-intervention (F [1, 53] = 5.51; p = 0.02; η2p = 0.09), but no interaction between time and group (F [1, 53] = 0.57; p = 0.46; η2p = 0.01). Table  Adjusted within-group differences for pain intensity, fear of movement, fear-avoidance beliefs, tacti...
PMC10729350
Fear of movement and fear-avoidance beliefs, tactile acuity, muscle strength, and pressure pain thresholds
For fear of movement, FABQ-PA, FABQ-W, and PPT (p > 0.05) there was no significant main effect for time nor a significant interaction between time and group (p > 0.05; Table For tactile acuity, there were no statistically significant main effects for time or interactions (p > 0.05, Table For muscle strength, there was ...
PMC10729350
Discussion
AO, chronic idiopathic NP, pain
This study assessed the immediate effects of observing neck movements (AO) on NP intensity, fear of movement, fear-avoidance beliefs, neck muscles’ strength, and tactile acuity in individuals with chronic idiopathic NP when compared to the effects of observing a natural environment.Contrary to our hypothesis that AO wo...
PMC10729350
Clinical implications and future research
pain
The results of this study suggest that both observing neck exercises and natural landscapes may be used in clinical practice to reduce pain, potentially facilitating the administration of exercise and complementing pain education. Participants’ perceptions of the intervention were not assessed, but a few participants r...
PMC10729350
Limitations of the study
chronic pain
CHRONIC PAIN, BLIND
The present study results need to be interpreted considering its limitations. Assessors were not blind to the intervention received by each participant, which could have increased type I errors. Only immediate effects were assessed. The lack of a previously established and validated protocol of AO therapy in the treatm...
PMC10729350
Acknowledgements
This work was supported by the national funds through FCT - Fundação para a Ciência e a Tecnologia, I.P., within CINTESIS R&D Unit (UIDB/4255/2020 and UIDP/4255/2020) and within the scope of the project RISE (LA/P/0053/2020).
PMC10729350
Author contributions
T.A.S. - acquisition, analysis, and interpretation of data; and drafted the manuscript. M.B.A. - acquisition, analysis, and interpretation of data. R.A. - design of the work, analysis and interpretation of data. A.G.S. - conception and design of the work; interpretation of data; and revised the drafted version. All aut...
PMC10729350
Funding
Not applicable.
PMC10729350
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.
PMC10729350
Declarations
PMC10729350
Ethics approval and consent to participate
This study received ethical approval from the Ethics Committee of the University of Aveiro (21-CED/2020). All participants signed informed consent before entering the study.All methods were performed with the relevant guidelines and regulations (Declaration of Helsinki).
PMC10729350
Consent for publication
Not applicable.
PMC10729350
Competing interests
The authors declare no competing interests.
PMC10729350
Abbreviations
ScalePressure Pain
Action ObservationCentimetersFear Avoidance Belief Questionnaire – Physical Activity SubscaleFear Avoidance Belief Questionnaire – Work SubscaleKilogramsLeftNeck Disability IndexNeck PainNewtonsPain Catastrophizing ScalePressure Pain ThresholdsRightStandard DeviationTwo-point discriminationTampa Scale of KinesiophobiaV...
PMC10729350
References
PMC10729350
Abstract
PMC10476909
Background
ANL, HCC
HEPATOCELLULAR CARCINOMA
The aim of the study was to observe the safety and efficacy of anlotinib (ANL) alone or combined with S-1 in the first-line treatment of advanced hepatocellular carcinoma (HCC).
PMC10476909
Patients and methods
toxicity, ANL, HCC
ADVERSE REACTIONS, DISEASE
Fifty-four patients with untreated advanced HCC who could not be resected were randomly divided into the ANL group (n = 27) and ANL+S-1 group (n = 27). The ANL group was given 10 mg ANL orally once a day for 14 consecutive days, stopped for 1 week, and repeated every 21 days. The ANL+S-1 group was given 10 mg ANL once ...
PMC10476909
Results
ANL
DISEASE
A total of 44 patients were included in the results analysis, including 22 patients in the ANL group and 22 patients in the ANL+S-1 group. In the ANL group, the objective response rate (ORR) was 4.5% (1/22), the disease control rate (DCR) was 77.3% (17/22), the median progression-free survival (PFS) was 4.2 months (95%...
PMC10476909
Conclusions
ANL, HCC
ADVERSE REACTIONS
ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated.
PMC10476909
Keywords
PMC10476909
Introduction
tumor, ANL, tumor-related deaths, lung cancer, HCC
HEPATOCELLULAR CARCINOMA, TUMOR, OF PRIMARY LIVER CANCER, LUNG CANCER
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, accounting for 90% of primary liver cancers. China has a high incidence of HCC, accounting for more than half of the new cases in the world each year, and ranks second only to lung cancer in tumor-related deaths.Common treatments for HCC in...
PMC10476909
Patients and methods
PMC10476909
Study design and participants
Tumors, HCC, BCLC
ONCOLOGY, TUMORS
This is a prospective, single-center, real-world study to evaluate the efficacy and safety of ANL with or without S-1 in the first-line treatment of patients with advanced HCC. From February 2019 to August 2021, 54 HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage C (stage I–II, Child‒Pugh A–B, and at least ...
PMC10476909
Procedures
ANL
ADVERSE REACTIONS, DISEASE
The patients were randomly divided into the ANL group (n = 27) and the ANL+S-1 group (n = 27). Patients in the ANL group were treated with 10 mg of ANL once a day for 14 days. The ANL+S-1 group was treated with 10 mg of ANL once a day and 40 mg of S-1 twice a day. Both drugs were taken continuously for 14 days, discont...
PMC10476909
Statistical analysis
The chi-square test was used to compare the counting data of the two groups, the Kaplan‒Meier method was used to generate a survival curve, and the log-rank test was used to compare the difference in PFS and OS between the two groups. We used SPSS software (version 25.0) to perform all the statistical analyses. All sta...
PMC10476909
Results
PMC10476909
Antitumor activity
ANL
A total of 44 patients were involved in the efficacy analysis (efficacy-evaluable population), with 22 cases in the ANL group and 22 cases in the ANL+S-1 group. In the ANL group, 1 (4.5%) patient achieved a PR, but none achieved a CR. The ORR was 4.5% (1/22), and the DCR was 77.3% (17/22). The median PFS was 4.2 months...
PMC10476909
Safety
hand-foot, ANL, diarrhea, fatigue, major adverse reactions, hypertension
ADVERSE REACTIONS, ADVERSE EFFECTS, HYPERTENSION, EVENTS, HYPERTENSION
The most frequent adverse effects (AEs) were hypertension and fatigue. Hypertension, hand-foot skin, and diarrhea were among the grade 3 treatment-related AEs that occurred in 7 (15.9%) of the patients. Most of these events can be reversed by adjusting the dose of ANL or by taking other drugs (such as antihypertensive ...
PMC10476909
Discussion
NSCLC, ANL, fatigue, HCC, hypertension, hemoptysis, hand and foot syndrome
ADVERSE REACTIONS, ADVERSE REACTIONS, LOSS OF APPETITE, NSCLC, HYPERTENSION
In this phase II prospective clinical trial, we observed the efficacy and safety of ANL alone or in combination with S-1 in patients with advanced HCC. To the best of our knowledge, this is the first controlled study to evaluate ANL alone or in combination with S-1 in patients with advanced HCC. The results showed that...
PMC10476909
Conclusions
ANL, HCC
ADVERSE REACTIONS
In conclusion, ANL monotherapy is effective in the treatment of advanced HCC, and adverse reactions can be tolerated. However, ANL combined with S-1 did not improve ORR and DCR or prolong PFS and OS in advanced HCC patients.
PMC10476909
Acknowledgments
Funding: Beijing Medical and Health Public Welfare Foundation, Medical Science Research Foundation Project (YWJKJJHKYJJ-F3054D), Guangxi Medical and Health Key Discipline Construction Project.Disclosure: No potential conflicts of interest were disclosed.
PMC10476909
References
PMC10476909
Background
Web-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues.
PMC10134014
Objective
weight loss, overweight or obesity
This study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with ov...
PMC10134014
Methods
weight-related behaviors, weight loss
Parent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children’s weight loss goals (session contents included energy ba...
PMC10134014
Results
Using a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA...
PMC10134014
Conclusions
The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families.
PMC10134014
Trial Registration
ClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067
PMC10134014
Introduction
PMC10134014
Background
weight loss
CHILDHOOD OBESITY
Childhood obesity remains a major public health concern, especially for racial and ethnic minority youth who experience significantly higher rates of overweight and obesity than their non-Hispanic White peers [Efforts to understand the best practices for engaging African American families in behavioral weight loss prog...
PMC10134014
Objective
weight loss, overweight or obesity
SECONDARY
This study aimed to address this gap by evaluating a multitheoretical approach to engaging African American families in a tailored web-based weight loss program, including a novel focus on positive parenting practices. The Family Systems Theory highlights the importance of nurturance and positive parenting practices fo...
PMC10134014
Methods
PMC10134014
Overview of the FIT Trial
weight loss, overweight or obesity
The FIT trial was a randomized group cohort study that tested the efficacy of a motivational plus family-based weight loss (M+FWL) intervention compared with a comprehensive health education control group for reducing BMI among African American adolescents with overweight or obesity and their caregivers [In phase 1, fa...
PMC10134014
Participants
EVENTS
Participants were recruited through community partnerships, culturally relevant advertisements, and community events [
PMC10134014
Ethics Approval
This study was reviewed and approved by the Institutional Review Board of the University of South Carolina (approval no. Pro00016136). The parents signed informed consent forms, and adolescents provided verbal assent.
PMC10134014
Overview of the Web-Based Program
weight loss
After completing the phase 1 of the intervention, all participants (adolescents and parents) completed a tailoring questionnaire before being randomized to the web-based tailored intervention or the web-based comparison program. The tailoring questionnaire was used in the intervention to provide an individually tailore...
PMC10134014
Web-Based Tailored Intervention
PMC10134014
Overview of the Program
’s behavior, weight loss
The web-based intervention was tailored on numerous constructs from both parents and adolescents, including parenting, behavior, and cultural variables (Overview of the content and tailoring strategies used in the web-based intervention.The program began with a welcome session in week 1, which included an overview of t...
PMC10134014
Description of Content Sessions
adolescent-reported, weight loss
Each content session involved behavior-specific content, a check-in on barriers to autonomy-supportive parenting, introduction of a new positive parenting practice, a worksheet to practice parenting skills, conversation practice with a brief video and worksheet, and the development of an action plan for the upcoming we...
PMC10134014
Measures
All measures were collected by trained measurement staff (blinded to condition) at baseline, postintervention time point (8 weeks), and post–web-based intervention time point (16 weeks).
PMC10134014
Log-in Status and Duration
For the web-based tailored intervention only, program use data were used to evaluate whether participants logged into a given session and how long they spent logged in. Log-in status was defined based on whether a participant logged into a given session at all. The log-in duration was calculated based on the time stamp...
PMC10134014
BMI Measurements
Height (cm) and weight (kg) measurements were obtained using a Seca 880 digital scale and Shorr height board. BMI values were calculated using the standard BMI formula (kg/m
PMC10134014
PA Measurements
MVPA measurements were obtained using 7-day estimates from omnidirectional Actical accelerometers. For the adolescents, cut points developed for use in youth populations were used [
PMC10134014
Analysis Plan
To evaluate the effect of engagement with different types of tailored behavioral content, a hierarchical mixed model approach was used. Specifically, model 1 tested the effects of total log-in duration; total number of sessions completed (0-8); and covariates, including baseline MVPA, baseline BMI, demographics (income...
PMC10134014
Results
PMC10134014
PA Results
PMC10134014
Parents
In model 1, which included the total log-in duration, total number of sessions completed, and covariates, there was a positive effect of total log-in duration such that parents who spent more time logged in during the 8-week program had greater MVPA (In summary, parents who logged into the PA session had lower MVPA, bu...
PMC10134014
Adolescents
For adolescents, model 1 revealed a negative effect of total log-in duration (
PMC10134014
Discussion
PMC10134014
Principal Findings
This study investigated whether engagement with different tailored behavioral sessions, measured in terms of log-in status and duration, was associated with improvements in MVPA among African American families. Among parents, logging into the PA session was not associated with greater MVPA. However, consistent with our...
PMC10134014
Implications for Future Research
weight-related behaviors
This study has several important implications for future tailored web-based interventions. First, this is one of the first studies to demonstrate a behavior-specific pathway between engagement with tailored content and behavioral outcomes. Although previous studies have highlighted the importance of adherence by evalua...
PMC10134014
Strengths and Limitations
This study has several strengths, including the use of a multitheoretical framework, deep-level cultural tailoring, an underrepresented racial minority sample, and an objective measure of PA. The study design allowed us to compare the effects of engagement with different types of tailored behavioral sessions (eg, diet-...
PMC10134014
Conclusions
The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of web-based tailored interventions, especially for improving PA in African American families. Among parents, MVPA did increase with greater log-in duration for the PA and sedenta...
PMC10134014
Abbreviations
Weight Loss interventionmoderate
Families Improving TogetherMotivational and Family-Based Weight Loss interventionmoderate to vigorous physical activityphysical activity
PMC10134014
Background
toxicity, GCA
GCA, GIANT CELL ARTERITIS
Giant cell arteritis (GCA) is primarily treated with glucocorticoids (GCs), which have substantial toxicity. Tocilizumab, an interleukin-6-receptor inhibitor (IL-6Ri), showed beneficial effects in GCA, leading to its approval. This study investigated the efficacy and safety of sarilumab (another IL-6Ri) in GCA
PMC10577982
Methods
RECRUITMENT, REMISSION, GCA
This Phase 3, double-blind study comprised a 52-week treatment period and a 24-week follow-up phase. Eligible GCA patients were randomized to receive sarilumab 200 mg (SAR200 + 26W) or 150 mg (SAR150 + 26W) with a 26-week GC taper, or placebo with a 52-week (PBO + 52W) or 26-week (PBO + 26W) GC taper. The primary effic...
PMC10577982
Results
Of the planned 360 subjects, only 83 were randomized and 36 were included in the week 52 analysis. At week 52, 46% (
PMC10577982
Conclusions
Owing to the small sample size due to the early termination, it is difficult to draw clear conclusions from this study. There were no unexpected safety findings.
PMC10577982
Trial registration
ClinicalTrials.gov NCT03600805. Registered on July 26, 2018.
PMC10577982