Move-MORE for Lumbosacral Radiculopathy

This study is testing a program called Move-MORE for people with lumbosacral radiculopathy (sciatica), which is pain radiating from the lower back into the leg. Move-MORE combines mindfulness training, gentle physical activity, and motivational interviewing to help you manage pain, improve movement, and build confidence in making healthy changes. The researchers want to see if this online program is practical to use, enjoyable, and how it affects your pain, physical function, and daily activities. You might be able to join if you are between 18 and 65 years old, can stand for 10 minutes, and have had lumbosacral radicular pain below the knee for at least 12 weeks. The main way they will measure success is by looking at your Oswestry Disability Index scores, which measure how much your back pain affects your daily life, over 20 weeks. The current status of this study is unclear, and they plan to enroll 32 participants.

Study design
This is an interventional study testing a multicomponent behavioral program. It plans to enroll 32 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 20 weeks, with assessments at Week 0, Week 4, Week 8, and Week 20.

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NCT07125027

A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE

Recruiting
NAAges 18–75InterventionalTreatment
National University of Natural Medicine
~32 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Move-MORE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Proportion
Measured over End of study
+5 more outcomes measured
Lumbosacral Radiculopathy
Sciatica
Chronic Low Back Pain With a Neuropathic Component
Radiculopathy Lumbar
Chronic Pain (Back / Neck)
1 sites across 1 states
Oregon1
  • Ryan S Wexler, ND, MS · PRINCIPAL_INVESTIGATOR · National University of Natural Medicine

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Eligibility criteria

Inclusion

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 at least 12 weeks' duration, AND
Tampa Scale of Kinesiophobia score ≥ 23. If TSK \< 23, the participant must endorse at least two of the following experiences in the past month on a structured cognitive interview:
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)
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

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 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. 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 keep the device deactivated for the duration of study enrollment, unless reactivation is medically necessary. Individuals who reactivate spinal cord stimulation during the intervention period may be withdrawn from the study.
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 or meditation training (e.g., completion of a structured mindfulness-based program, meditation retreat, or equivalent training). Casual awareness of breathing, brief relaxation exercises, prayer, yoga without meditation, general stress-management strategies, or mindful awareness during routine activities do not meet this exclusion criterion unless they are part of a regular formal mindfulness meditation practice.
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 Investigator, may interfere with study participation, increase participant risk, or plausibly explain the participant's lumbosacral radicular pain. Participants with a history of cancer that has been treated and is currently stable, in remission, or under routine surveillance are eligible. Localized non-melanoma skin cancers (e.g., basal cell carcinoma or squamous cell carcinoma) do not meet this exclusion criterion unless they are expected to interfere with study participation.
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
  • Recruitment ProportionEnd of study

    The proportion of patients contacted who consent to screening

  • RetentionEnd of study

    Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit

  • Client Satisfaction QuestionnaireWeek 4, Week 8, Week 20

    Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.

  • AdherenceEnd of study

    The proportion of participants completing at least 5 intervention sessions

  • Adverse EventsEnd of study

    The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring during the study.

  • Intervention SatisfactionWeek 4, Week 8

    Satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report measure designed to assess satisfaction with health services.