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Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia

CompletedNCT03796481
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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)

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 45 people with chronic spinal pain without insomnia.

Study details

Official title
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia Compared to People With Chronic Spinal Pain Without Insomnia.
Sponsor
University Ghent
Collaborators
Vrije Universiteit Brussel; University Hospital, Ghent; Universitair Ziekenhuis Brussel; Research Foundation Flanders
Start date
2019-01-08
Primary completion
2022-07-28
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 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 …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03796481