Structural White and Gray Matter Correlates of Impaired Muscle Control and Deficient Pain Processing (NCT06143319) | Clinical Trial Compass
CompletedNot Applicable
Structural White and Gray Matter Correlates of Impaired Muscle Control and Deficient Pain Processing
Belgium80 participantsStarted 2015-10-01
Plain-language summary
Although the cause of persistent non-specific low back pain (LBP) remains unknown, structural and functional alterations of the brain, alterations in the lumbar muscles and dysfunction of the central nervous system have been proposed as underlying mechanisms. In this case-control study, 1) brain structure/function, 2) lumbar muscle function and 3) central pain processing are compared across four groups: 1) healthy participants, 2) recurrent LBP (both during pain flare and during pain remission), 3) chronic LBP and 4) fibromyalgia. According to previous research, healthy participants and fibromyalgia patients are two extremes of a "musculoskeletal pain continuum". Healthy participants representing one extreme of the continuum with no pain and fibromyalgia representing the other extreme of the continuum with chronic widespread pain. It is thought that different LBP populations (i.e. (sub)acute, recurrent, chronic LBP) float between the aforementioned extremes. Past studies already highlighted the need for studies comparing the pathophysiological mechanisms for different pain syndromes to identify common underlying mechanisms across pain syndromes. For this reason, the goal of the current study is to compare alterations in brain structure/function, alterations in lumbar muscle function and alterations in central pain processing across the aforementioned "musculoskeletal pain continuum". It is hypothesized that longer duration of pain (recurrent vs chronic) and the extensiveness of the pain (one location vs widespread pain) are associated with more pronounced alterations in 1) brain structure/function, 2) lumbar muscle function and 3) central pain processing.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
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
. Dutch speaking female participants (age between 18 and 45 years).
. Non-specific recurrent LBP patients experiencing a period of remission at the moment of testing. Patients have to meet the criteria for recurrent LBP (in remission) as described by De Vet et al. (2002) and D'Hooge et al. (2013).
. Non-specific recurrent LBP patients experiencing a pain flare at the moment of testing. Patients have to meet the criteria for recurrent LBP (during pain flare) as described by De Vet et al. (2002) and D'Hooge et al. (2013).
. Participants experiencing non-specific chronic LBP (meeting the International Association for the Study of Pain \[IASP\] criteria)
. Participants diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) criteria (2010)
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
1
Brain structure and function
Timeframe: The entirety of the protocol for each patient is administered in a single day, spanning approximately 4 to 5 hours.
2
Pressure pain thresholds
Timeframe: The entirety of the protocol for each patient is administered in a single day, spanning approximately 4 to 5 hours.
3
Conditioned pain modulation
Timeframe: The entirety of the protocol for each patient is administered in a single day, spanning approximately 4 to 5 hours.
4
Nociceptive flexion reflex thresholds
Timeframe: The entirety of the protocol for each patient is administered in a single day, spanning approximately 4 to 5 hours.
5
Lumbar muscle function
Timeframe: The entirety of the protocol for each patient is administered in a single day, spanning approximately 4 to 5 hours.
. Healthy volunteers with no history of serious respiratory, orthopedic, neurologic or circulatory conditions. No history of low back pain (i.e. low back pain in this case is defined as a period of symptoms lasting a minimum of 2 consecutive days and for which a paramedic is consulted). Participants with a history of spinal surgery, spinal trauma or spinal deformities are also excluded. Healthy participants will be matched for age and BMI with included participants experiencing chronic/recurrent LBP or fibromyalgia.
Exclusion criteria
. Pregnancy or breastfeeding in the past year
. Contraindications for MRI (e.g. electrical/mechanical implants or electrodes in de body, eye/skin injury by metal fragments in the past, etc)
. BMI lower than 18 or higher than 30
. Participant performed specific trunk muscle training in the past year.