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Brain scans to unravel why poor sleep worsens back pain

NCT ID NCT06973837

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how chronic sleep problems and pain sensitivity are connected in people with long-term low back pain and insomnia. Researchers will use brain imaging, pain tests, and blood/stool samples in 80 adults to understand the underlying brain mechanisms. The goal is to gather knowledge, not to test a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal brain mechanisms linking sleep and pain, pointing toward better treatments for chronic back pain and insomnia.
What could go wrong
This is an observational study, not testing a treatment. It is small (80 people) and early-stage, so findings may not apply broadly or lead directly to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants across all study groups will be recruited from the broad area around Leuven, Belgium, via local flyers and social media. Participants with non-specific chronic low back pain and/or chronic insomnia will also be recruited from the pain and/or sleep center of UZ Leuven, Belgium, as well as via primary care units and patient support groups targeting people in the Leuven area. Participants will be recruited and stratified according to sex and age to enable matching to the primary group of interest (chronic low back pain and comorbid insomnia), and a majority of females (\~two thirds) will be recruited to better represent the sex-distribution within the population representative of this group.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 chronic low back pain. * Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography). * Restless leg syndrome * Central or peripheral neurological disorder/condition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy). * History of spinal surgery. * Major medical (e.g., cardiac disease, cancer) and/or psychiatric disorder/disease (e.g., major depressive disorder, bipolar disorder). * Claustrophobia. * Contraindications for magnetic resonance imaging (e.g., metal/cochlear implants, pacemaker). * Pregnancy or being \<12 months post-natal. Pharmacological exceptions criteria: \- Participants with chronic low back pain and/or (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and/or sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and/or insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and/or occasional use of low-to-moderate doses of over-the-counter medications for pain and/or sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions). Specific inclusion criteria for "pain-free" groups: * 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. Specific inclusion criteria for "chronic low back pain" groups: * 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. Specific inclusion criteria for "good sleeper" groups: * 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. Specific inclusion criteria for "chronic insomnia" groups: * 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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain insomnia Neuroinflammatory Diseases neuronitis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ/KU Leuven

    RECRUITING

    Leuven, 3000, Belgium

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