Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
CompletedNot applicableNCT03482856
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. The current strategies for treating CSP are not yet optimal in reducing pain and related disability, urging the need for improvement. A possible problem is that the current approaches are often to limited and only address pain. Current treatments for CSP do not address associated complaints like sleeping problems which are however important issues. If present, sleeping problems may contribute to CSP severity and related disability. If left untreated, they represent a barrier for effective CSP management. Up to now, however, sleeping problems are hardly addressed and if so, it is mostly limited to sleeping medication. This is a problem since the efficacy and safety of drug treatment has not been established. Therefore, within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene, altering sleeping patterns, and teaching relaxation skills. The objectives of the study are to examine if CBT-I combined with the modern physical therapy approach (education about pain followed by exercise therapy) is more effective than the modern physical therapy approach alone for reducing pain, improving sleep and functionality in CSP patients with sleeping problems. Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2 treatment programs (60 per group) and will be assessed before and after their 14-week therapy program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep quality and functionality.
Study details
- Official title
- Cognitive Behavioural Therapy for Insomnia in Patients With Chronic Spinal Pain: a Multi-center Randomized Controlled Trial
- Conditions
- Chronic Low Back Pain
- Chronic Neck Pain
- Insomnia Chronic
- Interventions
- Behavioral: MNA plus CBT-I
- Behavioral: MNA alone
- Sponsor
- University Ghent
- Collaborators
- Vrije Universiteit Brussel; Universitair Ziekenhuis Brussel; University Hospital, Ghent; Research Foundation Flanders
- Start date
- 2018-03-29
- Primary completion
- 2022-07-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Nonspecific spinal pain for at least 3 months' duration, at least 3 days per week * Seeking care because of neck pain or low back pain * Native Dutch speaker * Having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as \> 30 minutes of sleep latency and/or minutes awake after sleep onset for \> 3 days / week for \> 6 months * Living or working within a radius of 50 km around the therapy location * Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state) * Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments * Nonspecific failed back surgery \> 3 years are permitted * Not undertaking exercise (\> 3 metabolic Equivalents) 3 days before the assessments Exclusion Criteria: * Severe underlying sleep pathology (identified through baseline data of polysomnography) * Neuropathic pain * Chronic widespread pain * Being pregnant or pregnancy (including given birth) in the preceding year * History of specific spinal surgery * Thoracic pain in absence of neck or low back pain * Shift workers * Diagnosed depression * Body Mass Index below 30
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03482856