Status:
COMPLETED
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Vrije Universiteit Brussel
University Hospital, Ghent
Conditions:
Chronic Low Back Pain
Chronic Neck Pain
Eligibility:
All Genders
18-65 years
Brief Summary
This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to...
Eligibility Criteria
Inclusion
- Inclusion criteria cases:
- nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome \> 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
- aged between 18 and 65 years
- 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 test location
- not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain steady state)
- referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
- nonspecific failed back surgery \> 3 years are permitted
- not undertaking exercise (\>3 metabolic equivalents) 3 days before the experiment
- Exclusion criteria cases:
- severe underlying sleep pathology (identified through baseline data of polysomnography)
- neuropathic pain
- chronic widespread pain
- being pregnant or pregnancy (including giving birth) in the preceding year
- history of specific spinal surgery
- thoracic pain in absence of neck or low back pain
- shift workers
- present clinical depression
- BMI ≥ 30
- Inclusion criteria controls:
- native dutch speaking
- 18 to 65 years of age
- having chronic nonspecific chronic spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome \> 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
- referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
- not undertaking exercise (\>3 metabolic equivalents) 3 days before the experiment
- No new medication 6 weeks prior to the assessment
- currently not undergoing any treatment (excl. medication) for chronic spinal pain
- Exclusion criteria controls:
- specific medical conditions (neuropathic pain, specific neck of back surgery, osteoporotic vertebral fractures, or rheumatologic diseases)
- chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
- 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)
- severe underlying sleep pathology
- being pregnant or pregnancy in the preceding year
- thoracic pain in the absence of neck or low back pain
- diagnosed depression
- BMI over 30
Exclusion
Key Trial Info
Start Date :
January 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03796481
Start Date
January 8 2019
End Date
July 28 2022
Last Update
December 1 2022
Active Locations (2)
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1
Vrije Universiteit Brussel
Brussels, Belgium
2
Ghent University
Ghent, Belgium