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

NCT ID: NCT03796481

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2022-07-28

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 45 people with chronic spinal pain without insomnia.

Conditions

Chronic Low Back Pain; Chronic Neck Pain; Chronic Insomnia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cases

People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) with comorbid insomnia

No interventions assigned to this group

Controls

People with chronic spinal pain (i.e. chronic low back pain or chronic neck pain) without comorbid insomnia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vrije Universiteit Brussel

Brussels, , Belgium

Ghent University

Ghent, , Belgium

Countries

Belgium

Other Identifiers

EC/2018/0277/Amend

Identifier Type: -

Identifier Source: org_study_id