The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial

Background: Insomnia is a highly prevalent and debilitating comorbidity that is often not addressed in therapy for chronic spinal pain (CSP). Given the close interaction between insomnia and CSP severity and related disability, targeting sleep problems during therapy could improve treatment outcomes in these patients. Objective: Can cognitive behavioral therapy for insomnia (CBT-I) combined with the modern neuroscience approach (i.e. pain neuroscience education and cognition-targeted exercise therapy) reduce pain and improve sleep, physical activity and function in people with CSP and comorbid insomnia? Methods: Participants: One-hundred-twenty participants with chronic spinal pain and comorbid insomnia Intervention: CBT-I combined with the modern neuroscience approach (experimental) compared to the modern neuroscience approach alone (control). Both interventions start with three sessions of pain neuroscience education, followed by six sessions of CBT-I and nine sessions of cognition-targeted exercise therapy in the experimental group, or 15 sessions of cognition-targeted exercise therapy in the control group. Measurements: Primary outcome measure: self-reported pain severity (Brief Pain Inventory). Secondary outcome measures: pain sensitivity (pressure pain thresholds, and online questionnaires), sleep-related outcomes (home-based polysomnography and online questionnaires), physical activity (actigraphy), and function (online questionnaires). Online questionnaires will be completed at baseline, directly post-treatment, and at 3, 6 and 12 months post-treatment. Polysomnography, pressure pain thresholds and actigraphy will be carried out at baseline, post-treatment and at 12 months follow-up. Discussion: Findings may provide (1) a novel therapeutic approach for people with CSP and comorbid insomnia to improve pain, sleep, physical activity and function, and (2) new treatment guidelines for professionals. Trial registration: Clinicaltrials.gov NCT03482856 (https://clinicaltrials.gov/ct2/show/NCT03482856).SCOPUS: ar.j