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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 66
Healthy Volunteers: f
View:

• ● 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)

Locations
United States
Oregon
National University of Natural Medicine
RECRUITING
Portland
Contact Information
Primary
Ryan S Wexler, ND, MS
morestudy@nunm.edu
503-552-1741
Backup
Study Coordinator, MA
morestudy@nunm.edu
503-552-1752
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-11
Participants
Target number of participants: 32
Treatments
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
Sponsors
Collaborators: Oregon Health and Science University, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: National University of Natural Medicine

This content was sourced from clinicaltrials.gov