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.
Adults age 18-75 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
Avoids movement due to fear of injury
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.
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);
Single group
Move-MORE
BehavioralMove-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.
Recruitment Proportion
The proportion of patients contacted who consent to screening
Retention
Retention will be assessed by tracking the percentage of participants who complete their primary endpoint visit
Client Satisfaction Questionnaire
Intervention Satisfaction. Min = 8, Max = 32. Higher score = greater satisfaction.
Adherence
The proportion of participants completing at least 5 intervention sessions
Oswestry Disability Index
Activities of daily living. Min = 0%, Max = 100%. Higher score = worse outcomes.
painDETECT Questionnaire
Neuropathic Pain. Min = -1, Max = 38. Higher score = worse outcomes.
Visual Analog Scale
Pain Intensity. Min = 0, Max = 10. Higher score = worse pain
Complex Medical Symptoms Inventory
A questionnaire to assess pain hypersensitivity and allodynia. The CMSI inquires about participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Currently, no direct measures of self-reported nociplastic pain exist, thus measures of central sensitization can be used as surrogate measures for this construct. The CSI has previously been shown to have strong test-retest reliability in chronic pain patients.
Actigraph LEAP 2.0
Biometric tracking will take place via the wearing of an actigraphy device. The device will track activity level and several parameters of sleep. This is a research grade actigraphy device. All participant data will be uploaded to a secure platform stored exclusively on a computer at Helfgott Research Institute. Only participant study IDs will be used within the data collection platform.
Michigan Visual Aversion Stress Test (M-VAST 3)
Visual Stressors will probe mechanisms of global or generalized sensory sensitivity that bypass somatic peripheral receptors and the spinal cord, and are increased in many chronic pain patients. For visual testing, participants will be presented with a flashing annular checkerboard pattern at varying illumination levels as performed previously. Participants will be acclimated to a dark room and exposed to a high resolution, calibrated LED monitor displaying the visual stimulus. Each visual stimulus intensity level and the entire task will be rated on both sensory intensity and unpleasantness scales with overall task ratings and stimulus-response curves generated for analysis. Participants who report being diagnosed with or self-report visual-evoked migraines will not participate in the visual testing.
Algometry (Pressure Pain Threshold) - Wagner FPX-25
Objective measure of pain to assess participants' response to pressure. Algometers are designed to quantify and document levels of tenderness via pressure pain threshold measurement and pain sensitivity via pressure pain tolerance measurement. Overall, digital algometers have been shown good validity in patients with migraine and low back pain.
Pinprick (Mechanical Pain Threshold)
Pinprick testing assesses mechanical pain threshold (MPT), a measure of nociceptive sensitivity to punctate mechanical stimuli. Standardized, weighted pinprick stimulators, 256 millinewtons will be applied perpendicularly to the skin at a non-painful site (volar forearm or upper trapezius, lower back, and the area of most pain). This test is used to evaluate central sensitization. Pinprick testing is non-invasive, well-tolerated, and commonly included in quantitative sensory testing (QST) protocols to assess changes in mechanical pain sensitivity.
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
