Lumbosacral Radiculopathy study: Move-MORE
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
- This study is testing whether a combined mindfulness, gentle movement, and motivational interviewing program can help people with lumbosacral radiculopathy.
- Who it's for
- You may be able to join if you have sciatica or chronic low back pain that involves nerve pain.
- What's involved
- You will join online lessons about mindfulness, gentle exercises, and motivation. You will fill out short surveys, do brief daily phone check‑ins, wear a small activity monitor on your hip, and take a pain‑sensitivity test. At the end you will share your thoughts in an interview.
- Time commitment
- The study runs for several weeks with weekly online sessions and regular check‑ins, plus wearing the monitor the whole time.
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 75
You may be able to join if
- Adults age 18-75 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...
- Avoids movement due to fear of injury
- Believes pain indicates harm/damage
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...
- 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...
- Presence of moderate to severe foot drop, defined as noticeable weakness in ankle dorsiflexion that interferes with walking or requires the use of an...
See the full eligibility criteria
Who can join
- Adults age 18-75 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...
- Avoids movement due to fear of injury
- Believes pain indicates harm/damage
- Believes that movement is unsafe despite clinician reassurance
- Reports limiting or modifying activity because of fear (not just pain)
- 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;
- 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.
- 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).
- Current use of a spinal cord stimulator. Individuals with an implanted spinal cord stimulator may be eligible if the device has been deactivated for at least 4 weeks prior to enrollment and the participant agrees to...
- Have received a lumbosacral nerve ablation in the prior 3 months
- 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 regular mindfulness meditation practice, defined as formal seated, lying, or walking meditation practiced at least once per week for the past 4 weeks or longer, and/or a history of substantial formal mindfulness...
- Active malignancy requiring ongoing systemic treatment (e.g., chemotherapy, immunotherapy, targeted therapy, or radiation therapy), or malignancy that, in the judgment of the Principal Investigator or Clinical...
- 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
- 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 is enrolling
- 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, but 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.