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

Laura E Simons, Lauren E Harrison, Shannon F O'Brien, Marissa S Heirich, Nele Loecher, Derek B Boothroyd, Johan W S Vlaeyen, Rikard K Wicksell, Deborah Schofield, Korey K Hood, Michael Orendurff, Salinda Chan, Sam Lyons, Laura E Simons, Lauren E Harrison, Shannon F O'Brien, Marissa S Heirich, Nele Loecher, Derek B Boothroyd, Johan W S Vlaeyen, Rikard K Wicksell, Deborah Schofield, Korey K Hood, Michael Orendurff, Salinda Chan, Sam Lyons

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.

Keywords: Adolescents; Behavioral exposure; Chronic pain; Physical therapy; Single-case experimental design.

© 2019 The Authors.

Figures

Fig. 1
Fig. 1
Study Flowchart.Eligibility Screnning: Once a potential adolescent is referred to the GET Living trial, the research coordinator confirms eligibility and schedules the baseline assessment. Baseline: At the baseline assessment the adolescent and parent begin daily diaries, adolescents begin wearing the Actigraph watch, and biomechanical assessment is completed. At the baseline visit the adolescent and parent receive a treatment start date and schedule for sessions (arm allocation is not revealed). Active Treatment: Adolescent and one caregiver/parent present (as developmentally appropriate) for 12 sessions of treatment scheduled over the course of 6–8 weeks, taking into account holidays and vacations. Discharge assessment occurs at the conclusion of treatment. Actigraph is returned to the research team and daily diaries end. Follow-up: Adolescents and parents are sent a battery of questionnaires and daily diaries via REDCap for a 7-day period at 3-month and 6-month follow-up.

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