Complexity & Distraction in LBP (NCT03633578) | Clinical Trial Compass
CompletedNot Applicable
Complexity & Distraction in LBP
France16 participantsStarted 2018-04-01
Plain-language summary
Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.
The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.
Who can participate
Age range
18 Years – 75 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:
* The patient must have his informed consent and signed the consent form.
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is at least 18 years old and under 75 years old
* Patients with common chronic low back pain for more than 6 months
Exclusion Criteria:
* The subject participates in another interventional study
* The subject is in an exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship
* The subject refuses to sign the consent
* It is impossible to inform the subject
* Chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory)
* Unable to walk for more than 10 minutes (during interrogation)
* Lower limb pain (EVA lower limb (s) ≥ Lumbar EVA)
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
Estimation of the fractal exponent when walking without distraction at preferential speed
Timeframe: Day 0
2
Estimation of the fractal exponent when walking with distraction at preferential speed
Timeframe: Day 0
3
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
Timeframe: Day 0
4
Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed