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Unravelling the Neurobiological Mechanisms Underlying the Bidirectional Relationship Between Chronic Sleep Disturbances and Pain Sensitivity in People With Non-specific Chronic Low Back Pain and Chronic Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• 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.

• Currently pain free, defined as having no pain that affects daily living/functioning and/or which has led to a consultation with a healthcare practitioner.

• No episode of low back pain that interfered with daily functioning/living and/or which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.

• No history of chronic low back pain.

• Low back pain reported on most days (≥50%), every week, for more than 3 months.

• Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.

• Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).

• Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).

• A Pittsburgh Sleep Quality Index ≤5.

• An Insomnia Severity Index ≤7.

• An Epworth Sleepiness Scale ≤10.

• Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.

• No episode of sleep disturbances that interfered with daily functioning/living and/or which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.

• No history of chronic insomnia.

• Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).

• An Insomnia Severity Index ≥15.

Locations
Other Locations
Belgium
UZ/KU Leuven
RECRUITING
Leuven
Contact Information
Primary
Iris Coppieters, PT, PhD
iris.coppieters@vub.be
+32 497 92 90 32
Backup
Elin Johansson, PT, MSc
elinmarie.johansson@kuleuven.be
+46 702 05 54 52
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2026-10
Participants
Target number of participants: 80
Treatments
Pain-free with good sleep habits (healthy controls)
Meeting all General inclusion/exclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for pain-free and good sleeper.
Non-specific chronic low back pain with good sleep habits
Meeting all General inclusion/exclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for chronic low back pain and good sleeper.
Pain-free with chronic insomnia
Meeting General inclusion/exclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for pain-free and chronic insomnia.
Non-specific chronic low back pain with comorbid chronic insomnia
Meeting all General inclusion/exclusion criteria and Pharmacological exceptions criteria, plus the specific inclusion criteria for chronic low back pain and chronic insomnia.
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel
Collaborators: Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek), Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov