Contemporary Clinical Trials Communications (Dec 2019)

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

Journal volume & issue
Vol. 16

Abstract

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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: Chronic pain, Adolescents, Physical therapy, Behavioral exposure, Single-case experimental design