Status:
RECRUITING
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Lead Sponsor:
National University of Natural Medicine
Collaborating Sponsors:
Oregon Health and Science University
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Lumbosacral Radiculopathy
Sciatica
Eligibility:
All Genders
18-66 years
Phase:
NA
Brief 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 part...
Detailed Description
Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, ...
Eligibility Criteria
Inclusion Criteria:
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● Adults age 18-65 years at the time of enrollment
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Ability to stand for 10 minutes
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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
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Tampa Scale of Kinesiophobia score ≥ 23
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At least one positive physical examination finding consistent with lumbosacral radiculopathy, including at least one of the following:
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Positive straight leg raise test (eliciting radicular pain below the knee at ≤70 degrees of elevation);
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Positive Valsalva maneuver (eliciting radiculcar pain below the knee);
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Positive slump test;
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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.
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Daily access to the internet via cell phone, tablet, or computer
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Willing to engage with Move-MORE 4-5 times per week on your own
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Willing to attend a two-hour-long virtual Zoom meeting once per week for eight weeks
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Willing to attend two in-person study visits and a follow-up visit
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Willing to complete 18 questionnaires pertaining to your pain symptoms, quality of life, psychosocial experiences, and your experiences in the trial
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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
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Willing to respond to a daily online survey for the duration of study participation
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Able to speak, read, and understand the English language
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Able to provide written informed consent
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Moderately motivated to participate as reported on a numeric rating scale (≥ 4/10)
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Exclusion Criteria:
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● 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.
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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:
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New-onset urinary retention or overflow incontinence not attributable to other known causes;
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Fecal incontinence;
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New onset of saddle anesthesia (loss of sensation in the buttocks, perineum, and inner thighs);
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Severe or progressive bilateral lower extremity weakness;
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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 suspected or worsening foot drop will be referred for further evaluation and are not eligible for study participation.
- 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 weeks (i.e., five months) after enrollment
- Currently participating in another interventional research study or participated in another interventional 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
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Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07125027
Start Date
August 15 2025
End Date
November 1 2026
Last Update
November 12 2025
Active Locations (1)
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1
National University of Natural Medicine
Portland, Oregon, United States, 97201