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Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.

ABSTRACT: Chronic musculoskeletal pain in adolescence is a significant public health concern with 3-5% of adolescents suffering from significant pain-related disability. Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment. To address this need, we developed graded exposure treatment for youth with chronic pain (GET Living). We describe the rationale, design, and implementation of a two-group randomized controlled trial (RCT) enhanced with single-case experimental design (SCED) methodology with a sample of 74 adolescents with chronic musculosketal pain and their parent caregivers. GET Living includes education, behavioral exposures, and parent intervention jointly delivered by pain psychology and physical therapy providers. The multidisciplinary pain management control group includes pain psychology delivered education and pain self-management skills training (e.g., relaxation, cognitive skills) and separate physical therapy. Assessments include brief daily diaries (baseline to discharge, 7-days at 3-month and 6-month follow-up), comprehensive in-person evaluations at baseline and discharge, and questionnaire across all time points (baseline, discharge, 3-month and 6-month follow-up). Primary outcome is pain-related fear avoidance. Secondary outcome is functional disability. We also outline all additional outcomes, exploratory outcomes, covariates, and implementation measures. The objective is to offer a mechanism-based, targeted intervention to youth with musculoskeletal pain to enhance likelihood of return to function.

SUBMITTER: Simons LE

PROVIDER: S-EPMC6804549 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.

Simons Laura E LE Harrison Lauren E LE O'Brien Shannon F SF Heirich Marissa S MS Loecher Nele N Boothroyd Derek B DB Vlaeyen Johan W S JWS Wicksell Rikard K RK Schofield Deborah D Hood Korey K KK Orendurff Michael M Chan Salinda S Lyons Sam S

Contemporary clinical trials communications 20190910

Chronic musculoskeletal pain in adolescence is a significant public health concern with 3-5% of adolescents suffering from significant pain-related disability. Pain-related fear and avoidance of activities has been found to have a significant influence on pain outcomes in children and adolescents and is a risk factor for less favorable response to treatment. To address this need, we developed graded exposure treatment for youth with chronic pain (GET Living). We describe the rationale, design, a ...[more]

PMID: 31650069

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Project description:Quasi-experimental clinical trial.This study compared outcomes from graded exercise and graded exposure activity prescriptions for patients participating in a multidisciplinary rehabilitation program for chronic low back pain. Our primary purpose was to investigate whether pain and disability outcomes differed based on treatment received (graded exercise or graded exposure). Our secondary purpose was to investigate if changes in selected psychological factors were associated with pain and disability outcomes.Behavioral interventions have been advocated for decreasing pain and disability from low back pain, yet relatively few comparative studies have been reported in the literature.Consecutive sample with chronic low back pain recruited over a 16-month period from an outpatient chronic pain clinic. Patients received physical therapy supplemented with either graded exercise (n=15) or graded exposure (n=18) principles. Graded exercise included general therapeutic activities and was progressed with a quota-based system. Graded exposure included specific activities that were feared due to back pain and was progressed with a hierarchical exposure paradigm. Psychological measures were pain-related fear (Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, Fear of Pain Questionnaire), pain catastrophizing (Coping Strategies Questionnaire), and depressive symptoms (Beck Depression Inventory). Primary outcome measures were pain intensity (visual analog scale) and self-report of disability (modified Oswestry Disability Questionnaire).Statistically significant improvements (P<.01) were observed for pain intensity and disability at discharge. The rate of improvement did not differ based on behavioral intervention received (P>.05 for these comparisons). Overall, 50% of patients met criterion for minimally important change for pain intensity, while 30% met this criterion for disability. Change in depressive symptoms was associated with change in pain intensity, while change in pain catastrophizing was associated with change in disability.Physical therapy supplemented with graded exercise or graded exposure resulted in equivalent clinical outcomes for pain intensity and disability. The overall treatment effects were modest in this setting. Instead of being associated with a specific behavioral intervention, reductions in pain and disability were associated with reductions in depressive symptoms and pain catastrophizing, respectively.Therapy, level 2b–.

Project description:BackgroundChronic musculoskeletal (MSK) pain is a prominent health concern, resulting in pain-related disability, loss of functioning, and high health care costs. Physiotherapy rehabilitation is a gold-standard treatment for improving functioning in youth with chronic MSK pain. However, increasing physical activity can feel unattainable for many adolescents because of pain-related fear and movement avoidance. Virtual reality (VR) offers an immersive experience that can interrupt the fear-avoidance cycle and improve engagement in physiotherapy. Despite promising initial findings, data are limited and often lack the rigor required to establish VR as an evidence-based treatment for MSK pain.ObjectiveThis trial evaluates physiorehabilitation with VR in adolescents with MSK pain. This protocol outlines the rationale, design, and implementation of a randomized controlled trial enhanced with a single-case experimental design.MethodsThis study is a 2-group randomized controlled trial assessing the use of physiorehabilitation with VR in adolescents with MSK pain. The authors will collaborate with physical therapists to integrate VR into their standard clinical care. For participants enrolled in standard physiotherapy, there will be no VR integrated into their physical therapy program. Primary outcomes include physical function and engagement in VR. Secondary outcomes include pain-related fear and treatment adherence. Moreover, we will obtain clinician perspectives regarding the feasibility of integrating the intervention into the flow of clinical practice.ResultsThe pilot study implementing physiorehabilitation with VR demonstrated that high engagement and use of physiorehabilitation with VR were associated with improvements in pain, fear, avoidance, and function. Coupled with qualitative feedback from patients, families, and clinicians, the pilot study results provide support for this trial to evaluate physiorehabilitation with VR for youth with chronic MSK pain. Analysis of results from the main clinical trial will begin as recruitment progresses, and results are expected in early 2024.ConclusionsSignificant breakthroughs for treating MSK pain require mechanistically informed innovative approaches. Physiorehabilitation with VR provides exposure to progressive challenges, real-time feedback, and reinforcement for movement and can include activities that are difficult to achieve in the real world. It has the added benefit of sustaining patient motivation and adherence while enabling clinicians to use objective benchmarks to influence progression. These findings will inform the decision of whether to proceed with a hybrid effectiveness-dissemination trial of physiorehabilitation with VR, serving as the basis for potential large-scale implementation of physiorehabilitation with VR.Trial registrationClinicalTrials.gov NCT04636177; https://clinicaltrials.gov/ct2/show/NCT04636177.International registered report identifier (irrid)DERR1-10.2196/40705.

Project description:BackgroundChronic low back pain (cLBP) can interfere with daily activities, and individuals with elevated pain-related fear (also known as kinesiophobia or the fear of injury due to movement) can develop worse long-term disability. Graded exposure (GEXP) protocols use successive participation in avoided activities to help individuals overcome fearful movement appraisals and encourage activity. We sought to develop a series of GEXP virtual reality (VR) walking and reaching scenarios to increase the exposure and engagement of people with high kinesiophobia and cLBP.ObjectiveThis study aims to (1) determine GEXP content validity of the VR application and (2) determine the feasibility of individuals with cLBP performing locomotion-enabled physical activities.MethodsWe recruited 13 individuals with cLBP and high pain-related fear to experience six VR modules, which provide progressive movement exposure over three sessions in a 1 week period. At session 1, participants ranked each module by likelihood to avoid and assigned an expected pain and concern for harming their back rating to each module. Participants provided a rating of perceived exertion (RPE) after experiencing each module. To test feasibility, we administered the system usability scale (SUS) and treatment evaluation inventory (TEI) following the final session. In addition, we measured pain and pain-related fear at baseline and follow-up.ResultsThe 12 participants who completed the study period assigned higher avoidance (P=.002), expected pain (P=.002), and expected concern (P=.002) for session 3 modules compared with session 1 modules. RPE significantly increased from session 1 (mean 14.8, SD 2.3) to session 3 (mean 16.8, SD 2.2; P=.009). The VR application showed positive feasibility for individuals with cLBP through acceptable SUS (mean 76.7, SD 13.0) and TEI (mean 32.5, SD 4.9) scores. Neither pain (P=.20) nor pain-related fear (P=.58) changed significantly across sessions.ConclusionsThe GEXP VR modules provided progressive exposure to physical challenges, and participants found the VR application acceptable and usable as a potential treatment option. Furthermore, the lack of significant change for pain and pain-related fear reflects that participants were able to complete the modules safely.

Project description:IntroductionDifficulties in emotional regulation are key to the development and maintenance of chronic pain. Recent evidence shows internet-delivered dialectic behaviour therapy (iDBT) skills training can reduce emotional dysregulation and pain intensity. However, further studies are needed to provide more definitive evidence regarding the efficacy of iDBT skills training in the chronic pain population.Methods and analysisA single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of a 4-week iDBT-Pain skills training intervention (iDBT-Pain intervention) to reduce emotional dysregulation and pain intensity in individuals with chronic pain. The iDBT-Pain intervention encompasses two components: (1) iDBT-Pain skills training sessions (iDBT-Pain sessions) and (2) the iDBT-Pain skills training web application (iDBT-Pain app). Three individuals with chronic pain will be recruited and randomly allocated to different baseline phases (5, 9 or 12 days). Following the baseline phase, participants will receive six 60-90 min iDBT-Pain sessions approximately 4 or 5 days apart, delivered by a psychologist via Zoom. To reinforce learnings from the iDBT-Pain sessions, participants will have unlimited use of the iDBT-Pain app. A 7-day follow-up phase (maintenance) will follow the intervention, whereby the iDBT-Pain sessions cease but the iDBT-Pain app is accessible. Emotional regulation, as the primary outcome measure, will be assessed using the Difficulties in Emotion Regulation Scale. Pain intensity, as the secondary outcome measure, will be assessed using a visual analogue scale. Generalisation measures will assess psychological state factors (depression, anxiety and coping behaviour), alongside sleep quality, well-being and harm avoidance. SCEDs are increasingly considered effective designs for internet-delivered psychological interventions because SCED enables the investigation of interindividual variability in a heterogeneous population such as chronic pain.Ethics and disseminationThis trial was approved by the University of New South Wales (HC200199). Results will be published in peer-reviewed journals.Trial registration numberACTRN12620000604909.

Dataset Information

Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.

Publications

Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design.

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