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Recruiting NCT06973837

Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study

Trial Parameters

Condition Chronic Low Back Pain (CLBP)
Sponsor Vrije Universiteit Brussel
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-10-03
Completion 2026-10
Interventions
Real-life monitoring, experimental pain testing, brain imaging, blood and stool sampling.

Brief Summary

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.

Eligibility Criteria

General inclusion criteria (all groups): * 18-60 years old. * Ability to speak and understand the Dutch Language. * Body mass index \<30. * No smoking or nicotine use. * Low caffeine use (≤3 cups of coffee/day, ≤1 energy drink/day). * Low alcohol use (≤9 alcoholic units/week). * No use of neuro- and/or psychopharmacological treatments and/or immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below). * Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and/or strenuous physical activity (\>3 METs) in the 24 hours preceding the main test day. General exclusion criteria (all groups): * Shift worker. * Use of blood thinners. * (History of) Substance dependence/abuse. * Chronic pain conditions (≥3 months) other than

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