A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE (NCT07125027) | Clinical Trial Compass
RecruitingNot Applicable
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
United States32 participantsStarted 2025-08-15
Plain-language summary
The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes.
The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.
The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
Who can participate
Age range
18 Years – 66 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:
* ● Adults age 18-65 years at the time of enrollment
* Ability to stand for 10 minutes
* Presence of lumbosacral radicular pain within the past week that extends below the knee (i.e., pain radiating from the low back into the leg in a nerve root distribution) with or without accompanying low back pain, of at least 12 weeks' duration, AND
* Tampa Scale of Kinesiophobia score ≥ 23
* At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
* Positive straight leg raise test (eliciting radicular pain below the knee at ≤70 degrees of elevation);
* Positive Valsalva maneuver (eliciting radiculcar pain below the knee);
* Positive slump test;
* Neurological deficit in a lumbar nerve root distribution, including at least one of the following:
* Dermatomal sensory loss,
* Myotomal weakness, or
* Reduced or absent deep tendon reflexes (e.g., patellar or Achilles reflex) corresponding to the affected nerve root.
* Daily access to the internet via cell phone, tablet, or computer
* Willing to engage with Move-MORE 4-5 times per week on your own
* Willing to attend a two-hour-long virtual Zoom meeting once per week for eight weeks
* Willing to attend two in-person study visits and a follow-up visit
* Willing to complete 18 questionnaires pertaining to your pain symptoms, quality of life, psychosocial experiences, and your experiences in th…
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.