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Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

ABSTRACT: Chronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual.Pragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with ??=?5 %, ? = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations.A pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice.Clinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.

SUBMITTER: Dekker C

PROVIDER: S-EPMC4964076 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

Dekker Carolien C Goossens Mariëlle E J B ME Bastiaenen Caroline H G CH Verbunt Jeanine A M C F JA

BMC musculoskeletal disorders 20160728

<h4>Background</h4>Chronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with ...[more]

PMID: 27464953

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Project description:BACKGROUND:Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). OBJECTIVE:The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. METHODS:A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. RESULTS:Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample size of 99. The MMR+WEB intervention was effective over time (time*group) compared to MMR for the two-item CSQ catastrophizing subscale (P=.003), with an effect size of 0.61 (Cohen d) at 12 months. There were no significant between-group differences over time (time*group) regarding pain intensity, self-efficacy (pain, other symptoms, and general), or regarding six subscales of the two-item CSQ. Improvements over time (time) for the whole study group were found regarding mean (P<.001) and maximum (P=.002) pain intensity. The mean time spent in the Web-based program was 304 minutes (range 0-1142). Participants rated the items of Web-BCPA feasibility between 68/100 and 90/100. Participants in the MMR+WEB group were more satisfied with their MMR at 4 months (P<.001) and at 12 months (P=.003). CONCLUSIONS:Adding a self-guided Web-based intervention with a focus on behavioral change for activity to MMR can reduce catastrophizing and increase satisfaction with MMR. Patients in MMR may need more supportive coaching to increase adherence in the Web-BCPA to find it valuable. CLINICALTRIAL:Clinicaltrials.gov NCT01475591; https://clinicaltrials.gov/ct2/show/NCT01475591 (Archived by WebCite at http://www.webcitation.org/6kUnt7VQh).

Project description:BackgroundMusculoskeletal (MSK) pain disproportionately affects people from different ethnic backgrounds through higher burden and less access to care. Digital care programs (DCPs) can improve access and help reduce inequities. However, the outcomes of such programs based on race and ethnicity have yet to be studied.ObjectiveWe aimed to assess the impact of race and ethnicity on engagement and outcomes in a multimodal DCP for MSK pain.MethodsThis was an ad hoc analysis of an ongoing decentralized single-arm investigation into engagement and clinical-related outcomes after a multimodal DCP in patients with MSK conditions. Patients were stratified by self-reported racial and ethnic group, and their engagement and outcome changes between baseline and 12 weeks were compared using latent growth curve analysis. Outcomes included program engagement (number of sessions), self-reported pain scores, likelihood of surgery, Generalized Anxiety Disorder 7-item scale, Patient Health Questionnaire 9-item, and Work Productivity and Activity Impairment. A minimum clinically important difference (MCID) of 30% was calculated for pain, and multivariable logistic regression was performed to evaluate race as an independent predictor of meeting the MCID.ResultsA total of 6949 patients completed the program: 65.5% (4554/6949) of them were non-Hispanic White, 10.8% (749/6949) were Black, 9.7% (673/6949) were Asian, 9.2% (636/6949) were Hispanic, and 4.8% (337/6949) were of other racial or ethnic backgrounds. The population studied was diverse and followed the proportions of the US population. All groups reported high engagement and satisfaction, with Hispanic and Black patients ranking first among satisfaction despite lower engagement. Black patients had a higher likelihood to drop out (odds ratio [OR] 1.19, 95% CI 1.01-1.40, P=.04) than non-Hispanic White patients. Hispanic and Black patients reported the highest level of pain, surgical intent, work productivity, and impairment in activities of daily living at baseline. All race groups showed a significant improvement in all outcomes, with Black and Hispanic patients reporting the greatest improvements in clinical outcomes. Hispanic patients also had the highest response rate for pain (75.8%) and a higher OR of meeting the pain MCID (OR 1.74, 95% CI 1.24-2.45, P=.001), when compared with non-Hispanic White patients, independent of age, BMI, sex, therapy type, education level, and employment status. No differences in mental health outcomes were found between race and ethnic groups.ConclusionsThis study advocates for the utility of a DCP in improving access to MSK care and promoting health equity. Engagement and satisfaction rates were high in all the groups. Black and Hispanic patients had higher MSK burden at baseline and lower engagement but also reported higher improvements, with Hispanic patients presenting a higher likelihood of pain improvement.

Project description:IntroductionChronic musculoskeletal pain is a prevalent condition impacting around 20% of people globally; resulting in patients living with pain, fatigue, restricted social and employment capacity, and reduced quality of life. Interdisciplinary multimodal pain treatment programs have been shown to provide positive outcomes by supporting patients modify their behavior and improve pain management through focusing attention on specific patient valued goals rather than fighting pain.MethodsGiven the complex nature of chronic pain there is no single clinical measure to assess outcomes from multimodal pain programs. Using Centre for Integral Rehabilitation data from 2019-2021 (n = 2,364), we developed a multidimensional machine learning framework of 13 outcome measures across 5 clinically relevant domains including activity/disability, pain, fatigue, coping and quality of life. Machine learning models for each endpoint were separately trained using the most important 30 of 55 demographic and baseline variables based on minimum redundancy maximum relevance feature selection. Five-fold cross validation identified best performing algorithms which were rerun on deidentified source data to verify prognostic accuracy.ResultsIndividual algorithm performance ranged from 0.49 to 0.65 AUC reflecting characteristic outcome variation across patients, and unbalanced training data with high positive proportions of up to 86% for some measures. As expected, no single outcome provided a reliable indicator, however the complete set of algorithms established a stratified prognostic patient profile. Patient level validation achieved consistent prognostic assessment of outcomes for 75.3% of the study group (n = 1,953). Clinician review of a sample of predicted negative patients (n = 81) independently confirmed algorithm accuracy and suggests the prognostic profile is potentially valuable for patient selection and goal setting.DiscussionThese results indicate that although no single algorithm was individually conclusive, the complete stratified profile consistently identified patient outcomes. Our predictive profile provides promising positive contribution for clinicians and patients to assist with personalized assessment and goal setting, program engagement and improved patient outcomes.

Dataset Information

Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

Publications

Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

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