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:

  • ● 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 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)

Exclusion Criteria:

  • ● 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 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

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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National University of Natural Medicine

Portland, Oregon, United States, 97201