Examining the links between chronic low back pain and insomnia

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

This study is trying to see how chronic low back pain and insomnia are connected by looking at brain changes and how they affect each other in different groups of people.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Vrije Universiteit Brussel (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT06973837 on ClinicalTrials.gov

What this trial studies

This observational study investigates the neurobiological mechanisms that connect chronic low back pain and chronic insomnia, focusing on the role of neuroinflammation. Participants will be divided into four groups based on their health status and sleep patterns, including healthy controls and individuals with varying degrees of pain and insomnia. Over nine days, participants will complete questionnaires, maintain sleep diaries, and undergo pain testing and brain imaging. The study aims to enhance understanding of how sleep disturbances affect pain sensitivity and vice versa.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 who can communicate in Dutch and meet specific health criteria related to pain and sleep.

Not a fit: Patients with chronic pain conditions other than non-specific chronic low back pain or those with significant substance dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from chronic low back pain and insomnia.

How similar studies have performed: Previous studies have indicated a relationship between sleep disturbances and pain sensitivity, suggesting that this approach may yield valuable insights.

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 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.

Where this trial is running

Leuven

• UZ/KU Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: Iris Coppieters, PT, PhD

Conditions Chronic Low Back Pain; Chronic Insomnia; Neuroinflammation; Pain; Chronic pain; Chronic low back pain; Sleep; Insomnia