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New treatment option for Lumbosacral Radiculopathy
Official title A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
ClinicalTrials.gov ID: NCT07125027
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 66
You may be able to join if
- ● 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...
- Tampa Scale of Kinesiophobia score ≥ 23
- At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
You likely can't join if
- ● Participants will be excluded if they have clinical signs or symptoms of lumbosacral radiculopathy with progressive neurologic deficits (loss of...
- Participants with lumbosacral radiculopathy with progressive neurologic deficits will be referred for immediate medical attention, and are not...
- Participants will be excluded if they have clinical signs or symptoms suggestive of cauda equina syndrome, including any of the following:
- New-onset urinary retention or overflow incontinence not attributable to other known causes;
- Fecal incontinence;
- New onset of saddle anesthesia (loss of sensation in the buttocks, perineum, and inner thighs);
See the full eligibility criteria
Who can join
- ● 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...
- 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 the trial
- Willing to wear an actigraphy device all day, every day, and while sleeping, for the duration of study participation and willing to keep it charged
- Willing to respond to a daily online survey for the duration of study participation
- Able to speak, read, and understand the English language
- Able to provide written informed consent
- Moderately motivated to participate as reported on a numeric rating scale (≥ 4/10)
What rules you out
- ● Participants will be excluded if they have clinical signs or symptoms of lumbosacral radiculopathy with progressive neurologic deficits (loss of motor or sensory function) or intolerable pain.
- Participants with lumbosacral radiculopathy with progressive neurologic deficits will be referred for immediate medical attention, and are not eligible for participation in this study.
- Participants will be excluded if they have clinical signs or symptoms suggestive of cauda equina syndrome, including any of the following:
- New-onset urinary retention or overflow incontinence not attributable to other known causes;
- Fecal incontinence;
- New onset of saddle anesthesia (loss of sensation in the buttocks, perineum, and inner thighs);
- Severe or progressive bilateral lower extremity weakness;
- Participants with suspected cauda equina syndrome will be referred for immediate medical attention, and are not eligible for participation in this study.
- Presence of moderate to severe foot drop, defined as noticeable weakness in ankle dorsiflexion that interferes with walking or requires the use of an assistive device (e.g., ankle-foot orthosis). Participants with...
- Current use of a spinal cord stimulator
- Have received epidural steroid injection in the prior 3 months
- Have received a surgical intervention for low back pain or lumbosacral radiculopathy in the previous 6 months
- Current active mindfulness meditation practice 1 time/week or more, and/or history of formal training in mindfulness/meditation practice
- Concurrent diagnosis of cancer
- Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia, schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis
- Diagnosis of Borderline Personality Disorder or score \>6 on the McLean Screening Instrument for Borderline Personality Disorder
- Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment
- Major medical or surgical event requiring hospitalization (for any reason other than a minor scheduled medical procedure) within 3 months prior to screening; or, scheduled or will be scheduled to occur within the 20...
- Currently participating in another treatment research study or participated in another treatment study within 2 weeks prior to screening
- Any reason the Clinical Investigator or Principal Investigator believes confers increased risk to the potential participant, if they were to enroll in the study
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 66 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.