Actively Recruiting

Phase Not Applicable
Age: 18Years - 66Years
All Genders
NCT07125027

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

Led by National University of Natural Medicine · Updated on 2025-11-12

32

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

Sponsors

N

National University of Natural Medicine

Lead Sponsor

O

Oregon Health and Science University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 66Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults age 18-65 years at the time of enrollment
  • Ability to stand for 10 minutes
  • Lumbosacral radicular pain in the past week extending below the knee for at least 12 weeks
  • Tampa Scale of Kinesiophobia score of 23 or higher
  • At least one positive physical exam finding consistent with lumbosacral radiculopathy (positive straight leg raise test, Valsalva maneuver, slump test, or neurological deficit in lumbar nerve root distribution)
  • Daily internet access via phone, tablet, or computer
  • Willing to engage with Move-MORE program 4-5 times per week
  • Willing to attend weekly two-hour virtual Zoom meetings for eight weeks
  • Willing to attend two in-person study visits and a follow-up visit
  • Willing to complete 18 questionnaires about pain, quality of life, and psychosocial experiences
  • Willing to wear an actigraphy device all day and night during the study and keep it charged
  • Willing to respond to a daily online survey during the study
  • Able to speak, read, and understand English
  • Able to provide written informed consent
  • Moderately motivated to participate (rating 4 or higher on a 10-point scale)
Not Eligible

You will not qualify if you...

  • Clinical signs or symptoms of lumbosacral radiculopathy with progressive neurological deficits or intolerable pain
  • Signs or symptoms suggestive of cauda equina syndrome (new urinary retention, fecal incontinence, new saddle anesthesia, severe bilateral lower extremity weakness)
  • Moderate to severe foot drop affecting walking or requiring assistive device
  • Current use of a spinal cord stimulator
  • Received epidural steroid injection in the past 3 months
  • Had surgical intervention for low back pain or lumbosacral radiculopathy within the past 6 months
  • Active mindfulness meditation practice at least once weekly or prior formal mindfulness training
  • Diagnosis of cancer
  • Unmanaged or uncontrolled mental illness causing psychosis (schizophrenia, schizotypal disorders, bipolar I with psychosis, major depression with psychosis)
  • Diagnosis of Borderline Personality Disorder or score above 6 on the McLean Screening Instrument
  • Started or changed an exercise regimen within 2 weeks prior to screening or enrollment
  • Major medical or surgical event requiring hospitalization within 3 months before screening or planned within 5 months after enrollment
  • Participation in another interventional research study within 2 weeks prior to screening
  • Any condition deemed by investigators to increase risk if enrolled

AI-Screening

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Trial Site Locations

Total: 1 location

1

National University of Natural Medicine

Portland, Oregon, United States, 97201

Actively Recruiting

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Research Team

R

Ryan S Wexler, ND, MS

CONTACT

S

Study Coordinator, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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