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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-66
SponsorNational University of Natural Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

● 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

Disqualifiers

● 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.

New-onset urinary retention or overflow incontinence not attributable to other known causes;

Fecal incontinence;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 groups

32 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oswestry Disability Index

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

Time frame
Week 0, Week 4, Week 8, Week 20

Secondary outcomes

1

painDETECT Questionnaire

Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes.

Time frame
Week 0, Week 4, Week 8, Week 20
2

Client Satisfaction Questionnaire

Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.

Time frame
Week 4, Week 8, Week 20
3

Visual Analog Scale

Pain Intensity. Min = 0, Max = 10. Higher score = worse pain

Time frame
Daily

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Natural Medicine

Lead sponsor

Oregon Health and Science University

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator