Actively Recruiting
Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study
Led by Vrije Universiteit Brussel · Updated on 2025-12-15
80
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
V
Vrije Universiteit Brussel
Lead Sponsor
R
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.
CONDITIONS
Official Title
Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 60 years old
- Ability to speak and understand Dutch
- Body mass index less than 30
- No smoking or nicotine use
- Low caffeine intake (3 or fewer cups of coffee/day, 1 or fewer energy drinks/day)
- Low alcohol intake (9 or fewer alcoholic units/week)
- No use of neuro- or psychopharmacological treatments or immunosuppressive agents influencing neuroinflammation unless stopped with sufficient time before study or allowed by exceptions
- Willing to follow pre-test restrictions including avoiding analgesics (unless stable use), caffeine, alcohol, and strenuous physical activity in 24 hours before main test day
- For pain-free groups: currently pain free with no pain affecting daily life or requiring healthcare consultation, no low back pain episodes interfering with daily life in past 12 months, no history of chronic low back pain
- For chronic low back pain groups: low back pain on at least 50% of days weekly for more than 3 months, and pain-related emotional distress or functional disability rated 3 or higher out of 10
- For good sleeper groups: stable sleep schedule between 10 PM and 10 AM, average sleep time 7 to 9 hours, Pittsburgh Sleep Quality Index score 5 or less, Insomnia Severity Index 7 or less, Epworth Sleepiness Scale 10 or less, sleep efficiency 85% or higher during one-night polysomnography, no sleep disturbances interfering with daily life or requiring healthcare consultation in past 12 months, no history of chronic insomnia
- For chronic insomnia groups: chronic insomnia by ICSD-3-TR criteria, Insomnia Severity Index 15 or higher
You will not qualify if you...
- Shift worker
- Use of blood thinners
- Substance dependence or abuse history
- Chronic pain conditions other than chronic low back pain lasting 3 months or more
- Severe intrinsic sleep disorders diagnosed by polysomnography
- Restless leg syndrome
- Central or peripheral neurological disorders (e.g., epilepsy, multiple sclerosis, peripheral neuropathy)
- History of spinal surgery
- Major medical conditions (e.g., cardiac disease, cancer) or major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)
- Claustrophobia
- Contraindications for MRI (e.g., metal or cochlear implants, pacemaker)
- Pregnancy or less than 12 months post-natal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ/KU Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
I
Iris Coppieters, PT, PhD
CONTACT
E
Elin Johansson, PT, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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