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

NCT07125027 | Recruiting

• 2 other identifiers: RW6625K12NS130673
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.

  Week 0, Week 4, Week 8, Week 20

Secondary Outcomes (3)

• painDETECT Questionnaire

  Week 0, Week 4, Week 8, Week 20

• Client Satisfaction Questionnaire

  Week 4, Week 8, Week 20

• Visual Analog Scale

  Daily

Study Arms (1)

Treatment

EXPERIMENTAL

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

Behavioral: Move-MORE

Interventions

Move-MORE BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• ● 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

Sponsors & Collaborators

• National University of Natural Medicine: lead
• Oregon Health and Science University: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

RECRUITING

Related Links

• Helfgott Research Institute - Join a Study
• Helfgott Research Institute - Projects

MeSH Terms

Conditions

Sciatica; Chronic Pain; Motor Activity; Radiculopathy; Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ryan S Wexler, ND, MS

CONTACT

503-552-1741; morestudy@nunm.edu

Study Coordinator, MA

CONTACT

503-552-1752; morestudy@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Investigator

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 2027-
• Access Criteria: The data that support the findings of this study are available from the corresponding author, R.S.W., upon reasonable request.

Locations

US (1)