Recruiting

Mindfulness & Movement

Sponsor:

National University of Natural Medicine

Code:

NCT07125027

Conditions

Lumbosacral Radiculopathy

Sciatica

Chronic Low Back Pain With a Neuropathic Component

Radiculopathy Lumbar

Chronic Pain (Back / Neck)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Move-MORE

Study Details

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 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.

The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.

The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.

Conditions

Lumbosacral Radiculopathy

Sciatica

Chronic Low Back Pain With a Neuropathic Component

Radiculopathy Lumbar

Chronic Pain (Back / Neck)

Study ID

NCT07125027

Start date

Aug 15, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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 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.

o 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. 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Participants will go through the multicomponent Move-MORE program. Move-MORE is an integrated mind-body intervention which combines mindfulness, physical activity, and motivational interviewing informed by the principles of self-determination theory

Interventions

Move-MORE

Move-MORE is a multicomponent intervention which combines mindfulness training, physical activity, and motivational interviewing informed by the principles of self-determination theory. The version of Move-MORE being used in this study is specifically designed for use in patients with lumbosacral radiculopathy.

Primary outcome measure

  • Recruitment Proportion [ Time Frame: End of study ]
  • Retention [ Time Frame: End of study ]
  • Client Satisfaction Questionnaire [ Time Frame: Week 4, Week 8, Week 20 ]
  • Adherence [ Time Frame: End of study ]
  • Adverse Events [ Time Frame: End of study ]
  • Intervention Satisfaction [ Time Frame: Week 4, Week 8 ]

Central Contacts and Locations

Central contacts

Ryan S Wexler, ND, MS

503-552-1741morestudy@nunm.edu

Study Coordinator

503-552-1752morestudy@nunm.edu

Locations

National University of Natural Medicine

Recruiting

Portland, Oregon, United States, 97201

Contacts

Study Coordinator, MA

503-552-1752morestudy@nunm.edu

More Information

Sponsor

National University of Natural Medicine

Last update posted

Aug 26, 2026

Last verified

Nov, 2025

Keywords

  • Mindfulness
  • Physical Activity
  • Motivational Interviewing
  • Meditation
  • Tai Chi/Qi Gong
  • Movement
  • Mindfulness-Oriented Recovery Enhancement
  • Mindfulness-Based Interventions
  • Radiculopathy
  • Lumbosacral Radiculopathy
  • Lumbar Radiculopathy
  • Chronic low back pain
  • Low back pain
  • Back Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2026-08-26.