Actively Recruiting
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
N/A
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
Researchers are evaluating a multicomponent mindfulness and movement program called Move-MORE designed for patients with lumbosacral radiculopathy, a condition causing pain, weakness, and numbness in the lower limbs often known as sciatica. The study aims to develop this non-invasive, non-drug treatment by combining mindfulness training, gentle physical activity, and motivational interviewing to help manage pain and improve function. The study will assess the program's feasibility, acceptability, and preliminary effects on pain, disability, and psychological factors. Participants will engage in the Move-MORE program remotely, attending weekly virtual classes for eight weeks. The program includes mindfulness practice, physical activity, and motivational interviewing based on self-determination theory. Between sessions, participants will track their home practice, pain levels, and any adverse events through daily surveys. The intervention is specifically tailored for those with lumbosacral radiculopathy, using feedback from patients and physicians to guide program design. During the study, participants will complete online surveys at baseline, midpoint, post-intervention, and three-month follow-up, including daily pain ratings via ecological momentary assessment. They will wear an activity monitor continuously to measure movement and undergo quantitative sensory testing to assess pain sensitivity. At the end, participants will share their experiences in interviews to help refine the program. The primary outcome measured is disability related to back pain, with additional assessments of pain characteristics and satisfaction.
CONDITIONS
Brief Title
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18-65 years at the time of enrollment
- Ability to stand for 10 minutes
- Lumbosacral radicular pain 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, such as positive straight leg raise test, Valsalva maneuver, slump test, or neurological deficit
- Daily access to the internet via cell phone, tablet, or computer
- Willingness to engage with Move-MORE 4-5 times per week independently
- Willingness to attend weekly two-hour virtual classes for eight weeks
- Willingness to attend two in-person study visits and one follow-up visit
- Willingness to complete 18 questionnaires about pain, quality of life, and trial experiences
- Willingness to wear an activity monitor all day and night during study participation and keep it charged
- Willingness to respond to daily online surveys during study participation
- Ability to speak, read, and understand English
- Ability to provide written informed consent
- Moderate motivation to participate (rating of 4 or higher on a 10-point scale)
You will not qualify if you...
- Clinical signs of lumbosacral radiculopathy with progressive neurological deficits or intolerable pain
- Signs or symptoms suggesting cauda equina syndrome, including new urinary retention, fecal incontinence, saddle anesthesia, or severe bilateral leg weakness
- Moderate to severe foot drop interfering with walking or requiring assistive devices
- Current use of a spinal cord stimulator
- Epidural steroid injection within the past 3 months
- Surgical intervention for low back pain or radiculopathy within the past 6 months
- Active mindfulness meditation practice once a week or more, or history of formal mindfulness training
- Current cancer diagnosis
- Unmanaged or uncontrolled psychotic mental illness (e.g., schizophrenia, bipolar disorder with psychosis)
- Borderline Personality Disorder diagnosis or high score on screening instrument
- Started or changed exercise regimen within 2 weeks before screening
- Major medical or surgical hospitalization within 3 months before screening or planned within 20 weeks after enrollment
- Participation in another interventional study within 2 weeks before screening
- Any condition increasing risk as judged by the study investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 in-person visits
Duration - 8 weeks
Participants attend weekly virtual classes and engage with the Move-MORE program that combines mindfulness, physical activity, and motivational interviewing. They also complete daily surveys about pain and home practice tracking.
Weekly virtual classes for 8 weeks and daily online surveys
Duration - Up to 12 weeks after treatment
Participants complete a final in-person follow-up visit and participate in an exit interview about their experience with the intervention.
1 in-person follow-up visit
Trial Site Locations
Total: 1 location
1
National University of Natural Medicine
Portland, Oregon, United States, 97201
Actively Recruiting
Research Team
R
Ryan S Wexler, ND, MS
S
Study Coordinator, MA
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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