Move-MORE for Sciatica

(Move-MORE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National University of Natural Medicine

Must not be taking: Spinal cord stimulators

Disqualifiers: Cauda equina, Foot drop, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online program called Move-MORE, which combines mindfulness, gentle movement, and motivational support to help people with sciatica manage pain and improve daily activities. Researchers aim to assess the program's ease of use, engagement, and effects on pain and physical function. The trial is fully remote, involving online surveys, daily check-ins, and a small device to track activity. It seeks participants who have experienced sciatica pain radiating below the knee for at least 12 weeks and can stand for 10 minutes. Participants should be ready to engage with the program multiple times a week and attend virtual meetings. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies and contribute to advancing sciatica care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this program is safe for participants?

Research has shown that programs like Move-MORE, which emphasize mindfulness and gentle movement, are generally safe for individuals with conditions such as nerve pain in the lower back. The program includes mindfulness exercises, easy movements, and motivational support. These activities are non-invasive, meaning they don't involve surgery or medications, reducing the risk of serious side effects.

Previous studies on similar non-surgical treatments have not identified any major negative effects. Conducted online, the Move-MORE program avoids risks associated with physical treatments or medications, making it a well-tolerated option for managing pain and improving daily activities. Participants in similar programs have found them safe and helpful for managing their condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Move-MORE is unique because it offers an integrated mind-body approach to treating sciatica, which sets it apart from the standard treatments like pain medications, physical therapy, and sometimes surgery. By combining mindfulness, physical activity, and motivational interviewing, Move-MORE addresses not just the physical but also the psychological aspects of pain. Researchers are excited about this treatment because it is informed by self-determination theory, which emphasizes enhancing one's intrinsic motivation — a potentially powerful tool for long-term pain management and overall well-being.

What evidence suggests that the Move-MORE program is effective for sciatica?

Research has shown that programs like Move-MORE, which emphasize mindfulness and movement, may assist with sciatica, a condition affecting the lower back and legs. Techniques that gently move and stretch the nerves have significantly reduced pain and disability in individuals with this condition. While no single non-surgical treatment is deemed best for long-term sciatica, combining mindfulness, physical activity, and motivational support might offer a balanced approach to managing symptoms. Early results suggest that programs focusing on the mind-body connection can make physical activity more comfortable and improve overall function. Participants in this trial will engage in the multicomponent Move-MORE program, which integrates these elements. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

The Move-MORE trial is for individuals experiencing lumbosacral radiculopathy, commonly known as sciatica or chronic low back pain. Participants should be comfortable using online tools and willing to engage in mindfulness, gentle movement practices, and motivational interviewing remotely.

Inclusion Criteria

Tampa Scale of Kinesiophobia score ≥ 23

Willing to engage with Move-MORE 4-5 times per week on your own

I am between 18 and 65 years old.

Exclusion Criteria

Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment

Any reason the Clinical Investigator or Principal Investigator believes confers increased risk to the potential participant if they were to enroll in the study

I am experiencing symptoms that may indicate cauda equina syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the multicomponent Move-MORE program, which includes mindfulness, physical activity, and motivational interviewing, delivered entirely remotely.

8 weeks

Weekly virtual classes

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at baseline, midpoint, post-intervention, and 3-month follow-up.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Move-MORE

Trial Overview Move-MORE is a digital program combining mindfulness training, movement exercises, and motivational interviewing to manage pain and improve physical function in people with sciatica. The study measures feasibility, engagement levels, impact on pain/function/activity via surveys, daily check-ins, activity monitoring, sensory testing of pain sensitivity.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2219647/

Effectiveness of conservative treatments for the lumbosacral ... The aim of this systematic review was to assess the effectiveness of conservative treatments in the lumbosacral radicular syndrome when compared to placebo, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590025006583

Effectiveness of non-surgical interventions for patients with ... Currently, no high-quality evidence confirms the superior effectiveness of any non-surgical intervention for patients with chronic sciatica.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07125027

NCT07125027 | A Multicomponent Intervention for Patients ... The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy.

4. mdpi.com mdpi.com/2075-1729/13/12/2255

Neural Mobilization for Reducing Pain and Disability in ... Our meta-analysis revealed that the use of NM significantly reduced both pain and disability in lumbar radiculopathy. Regardless of the specific ...

5. thespinejournalonline.com thespinejournalonline.com/article/S1529-9430(17)31148-8/fulltext

Prognosis of sciatica and back-related leg pain in primary ... Results. A total of 609 patients were included. At 12 months, 55% of patients improved in both the total sample and the sciatica group.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11045257/

Understanding How Patients With Lumbar Radiculopathy ... Lumbar radiculopathy, characterized by pain radiating along a nerve root, significantly diminishes the quality of life due to its neuropathic nature.

7. e-neurospine.org e-neurospine.org/journal/view.php?number=1720

Evidence-Based Clinical Practice Guidelines for Patients ... LDH with associated radiculopathy is a commonly encountered musculoskeletal condition, often prompting most adults to seek medical support.

8. emedicine.medscape.com emedicine.medscape.com/article/1144130-overview

Low Back Pain and Sciatica: Overview, Pathophysiology ... An estimated 15-20% develop protracted pain, and approximately 2-8% have chronic pain. Of those individuals who remain disabled for more than 6 ...

9. physio-pedia.com physio-pedia.com/Lumbar_Radiculopathy

Lumbar Radiculopathy Other key points include: Majority of cases are benign and resolve spontaneously; Conservative management is typically the first approach; Diagnostic tools ...