Status:
COMPLETED
Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
Conditions:
Chronic Low Back Pain
Chronic Neck Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
Modern pain neuroscience has advanced our understanding of chronic spinal pain (CSP). Despite the scientific progresses with regard to the treatment of chronic spinal pain (CSP), current treatments fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03482856
Start Date
March 29 2018
End Date
July 30 2022
Last Update
December 1 2022
Active Locations (2)
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1
University Hospital Brussels
Brussels, Brussels Capital, Belgium, 1090
2
University Hospital Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000