Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain.

Alicia A Heapy,Caroline R Richardson,Rebecca A Czlapinski,Diana M Higgins,John D Piette,Kathryn M Lachappelle,Joseph L Goulet,Joseph Kirlin,Sarah L Krein,Eugenia Buta,Robert D Kerns

doi:10.1186/s12891-016-0924-z

Abstract

BackgroundThe Institute of Medicine report “Relieving Pain in America” recommends the promotion of patient self-management of pain for all people with pain. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidence-based treatments designed to facilitate self-management of chronic pain conditions. Although CBT is efficacious, many patients have limited or no access to CBT. Technology-assisted delivery of CBT may improve access while maintaining efficacy.Methods/DesignWe describe a randomized non-inferiority trial of interactive voice response (IVR)-based CBT for patients with chronic low back pain. This intervention uses daily IVR monitoring and weekly pre-recorded therapist feedback, based on patient-reported information, to provide treatment for patients at home. A total of 230 patients with chronic low back pain are being identified from a single statewide health system serving US military veterans. Participants are randomized to receive either ten weeks of in-person CBT or IVR-based CBT. The primary outcome is pain intensity as measured by the Numeric Rating Scale immediately post-treatment. Secondary outcomes include pain-related interference, emotional functioning, and quality of life measured immediately post treatment, and 6 and 9 months post recruitment. Exploratory objectives of the study are to examine: (1) potential mediators of impact on clinical outcomes (treatment retention, self-reported skill practice ratings, IVR call adherence, and treatment satisfaction); and (2) moderators of treatment engagement, adherence to therapist recommendations for pain coping skill practice, and effects on clinical outcomes.DiscussionThis non-inferiority trial may identify an alternative to resource intensive in-person CBT that allows many more patients to receive care while also increasing retention of those enrolled in the program.Trial registrationClinicalTrials.gov: NCT01025752. Registered 3 December 2009.

Highlights

Present rationale for treatment, explain pain cycle and introduce goal setting.- Complete one exercise each day in the “Your Guide to Setting Meaningful Activity Goals” section StretchingIntroduce stretching, its benefits, explain-Practice stretches provided in the handbook daily acute vs. chronic pain, beliefs about pain and provide suggested stretches to practice.-Set/ work on meaningful activity goalMovement, Walking & Body Mechanics Instructions for walking, body mechanics, -Practice body mechanics increasing activity and preventing injuries. -Increase daily steps +10 % of prior week’s steps- Set/ work on Meaningful activity goal-Continue to practice prior week’s skill Deep BreathingInstructions for diaphragmatic breathing and its benefits
Heapy et al BMC Musculoskeletal Disorders (2016) 17:85 (Continued from previous page). This non-inferiority trial may identify an alternative to resource intensive in-person cognitive behavioral therapy (CBT) that allows many more patients to receive care while increasing retention of those enrolled in the program
Need for pain self-management A recent Institute of Medicine (IOM) report estimates that approximately 100 million people in the US experience chronic pain at any one point in time [1]

Summary

Introduction

Present rationale for treatment, explain pain cycle and introduce goal setting.- Complete one exercise each day in the “Your Guide to Setting Meaningful Activity Goals” section StretchingIntroduce stretching, its benefits, explain-Practice stretches provided in the handbook daily acute vs. chronic pain, beliefs about pain and provide suggested stretches to practice.-Set/ work on meaningful activity goalMovement, Walking & Body Mechanics Instructions for walking, body mechanics, -Practice body mechanics increasing activity and preventing injuries. -Increase daily steps +10 % of prior week’s steps- Set/ work on Meaningful activity goal-Continue to practice prior week’s skill Deep BreathingInstructions for diaphragmatic breathing and its benefits. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidencebased treatments designed to facilitate self-management of chronic pain conditions. Need for pain self-management A recent Institute of Medicine (IOM) report estimates that approximately 100 million people in the US experience chronic pain at any one point in time [1]. The report highlights the frequent barriers to care experienced by individuals with pain and encourages the development of strategies to address those barriers. Relevant to these two recommendations are investigations of novel ways to provide access to evidencebased self-management interventions. A Cochrane review found combined cognitive and relaxation-based treatments were superior to a wait list control condition and resulted in moderate reductions in pain intensity [3]

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