RecruitingNot Applicable

The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

Belgium100 participantsStarted 2024-01-15

Plain-language summary

Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with non-specific low back pain: * Aged 18-60 years * Non-specific low back pain without radicular leg pain * Mechanical low back pain with episodes of \<4 on the numerical pain rating scale and episodes of \>6 on the numerical pain rating scale * Non-specific low back pain for three months or more * Score of 20% or more on the Modified Low Back Pain Disability Questionnaire * Informed consent to participate Healthy controls: * Aged 18-60 years * No history of low back pain needing medical treatment or resulting in a limited activity level * No low back pain in the previous six months * Informed consent to participate Exclusion Criteria: * Pregnancy * Previous trauma or surgery to the spine, pelvis or lower limbs * Structural spinal deformity (e.g., scoliosis) * Neurological, neuromuscular, respiratory or systemic disease * Central sensitization: score of 50/100 or more on the Central Sensitization Inventory * Specific vestibular or balance problems * Acute lower limb or neck problems * Body mass index of 30 kg/m² or more

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proprioceptive postural control at baseline 1 (t= 0 weeks)

Timeframe: At baseline 1 (t= 0 weeks)

Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)

Timeframe: At baseline 2 (t= 8 weeks)

Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)

Timeframe: After 8 weeks of training (t= 16 weeks)

Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)

Timeframe: After 16 weeks of training (t= 24 weeks)

Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients)

Timeframe: 16 weeks after the end of training (t= 40 weeks)

Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)

Timeframe: At t= 0 weeks

Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)

Trial details

NCT IDNCT05851196

SponsorHasselt University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Lotte Janssens, PhD

+3211292174 lotte.janssens@uhasselt.be

View on ClinicalTrials.gov More Low Back Pain trials