Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT03482856
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03482856
Study Brief:
Protocol Section:
NCT03482856