Stepped Care Management for Lower Back Pain
(SMART LBP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the best way to manage chronic lower back pain by comparing different treatments. Participants will begin with either physical therapy or the Move 2 Health (M2H) program, which emphasizes healthy habits like exercise and nutrition. Those who don't improve after six weeks will try additional treatments, including a possible mindfulness program. This trial suits active-duty military personnel or their family members who have experienced lower back pain for over three months and can attend treatment sessions for 16 weeks.
As an unphased trial, this study offers a unique opportunity to explore various treatment options tailored to participants' needs.
Do I need to stop my current medications for 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 trial coordinators or your healthcare provider.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that physical therapy is generally safe and effective for treating low back pain. Studies indicate that physical therapy, especially when combined with exercise, can significantly improve pain and mobility. For instance, a review of several studies found that exercise reduces the risk of low back pain and aids long-term movement.
Mindfulness practices, such as the MORE Mindfulness treatment, have also proven effective and safe. A large review of studies found that mindfulness meditation reduced chronic pain more effectively than other therapies, suggesting mindfulness as a useful and safe pain management option.
Specific safety information for the Move 2 Health (M2H) program is limited. However, M2H aims to encourage healthy lifestyle changes and, as part of Army Medicine's health system, is generally considered safe. This trial is in the "Not Applicable" phase, indicating early testing to assess safety and effectiveness. Overall, these treatments appear well-tolerated, but discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to treating lower back pain by combining traditional and innovative methods. Unlike standard care options like medication or surgery, this trial includes a personalized physical therapy plan and the Move 2 Health (M2H) program that emphasizes holistic lifestyle changes. Additionally, the trial uniquely incorporates a mindfulness component, the Mindfulness-Oriented Recovery Enhancement (MORE), specifically designed to address chronic pain in military personnel. This approach not only targets physical symptoms but also addresses mental and emotional factors, potentially providing a more comprehensive and effective management of lower back pain.
What evidence suggests that this trial's treatments could be effective for lower back pain?
Research has shown that physical therapy, one of the treatments in this trial, can greatly reduce pain for people with long-term low back pain. Studies have found that those who engage in physical therapy experience less pain compared to those who do not exercise. In this trial, some participants will receive physical therapy as their initial treatment.
Mindfulness-based methods, such as MORE Mindfulness, another treatment option in this trial, also help ease pain and improve mobility. Many participants report feeling less pain after mindfulness sessions. Participants in this trial may receive MORE Mindfulness as a Phase II intervention.
The Move 2 Health program, developed by the US Army, is also under study in this trial. It addresses low back pain from a whole-body perspective, focusing on healthy habits like good nutrition and regular physical activity. Although less research exists on Move 2 Health compared to other treatments, its emphasis on lifestyle changes may help manage pain. Participants may receive Move 2 Health as an initial treatment or in combination with other treatments in Phase II.678910Who Is on the Research Team?
Julie M Fritz, PhD
Principal Investigator
University of Utah
Daniel Rhon, PhD
Principal Investigator
Brooke Army Medical Center
Are You a Good Fit for This Trial?
This trial is for active duty military, reservists on active duty, their family members, or Tricare beneficiaries with chronic low back pain. Participants must be aged 18-65 and able to attend treatment sessions over a 16-week period. Exclusions include recent lumbar spine surgery, pending military discharge for medical reasons, serious causes of back pain like fractures or neoplasms, pregnancy, and certain treatments received in the past 6 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive either physical therapy (PT) or Move to Health (M2H) interventions for 6 weeks
Phase II Treatment
Non-responders to Phase I are randomized to receive either mindfulness or a combined PT+M2H intervention for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MORE Mindfulness
- Move 2 Health (M2H)
- Physical Therapy
Trial Overview
The study tests two initial treatments for chronic low back pain: physical therapy or Move 2 Health (M2H). Those not improving after six weeks enter Phase II where they either add the other initial treatment they didn't receive or start MORE Mindfulness intervention. The process involves random assignment and participants are monitored for one year.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Sequential Randomization: Participants randomized to receive mindfulness as a Phase II intervention will discontinue their Phase I treatment. The Mindfulness-Oriented Recovery Enhancement (MORE) treatment was designed specifically to address symptoms and underlying mechanisms of chronic pain in the military context and is led over 8 individual sessions.
Sequential Randomization: Participants randomized to receive a combination of PT and M2H as a Phase II intervention will continue their Phase I treatment (either M2H or PT). The participant will begin the treatment component that was not part of their Phase I intervention.
Initial Randomization: The initial PT treatment session will occur within 7 days of enrollment in the study. Precise dosage (i.e, number of PT sessions) will be at the discretion of the physical therapist directing the participant's care, up to a maximum of 2-3 sessions per week over the 6-week Phase I treatment period.
Initial Randomization: M2H is a key component of Army Medicine's "System for Health", along with the Performance Triad. It is a person-centered, holistic, and experience-centric approach to promoting healthy behaviors (nutrition, physical activity, sleep, instrinsic factors, extrinsic factors). Precise dosage (i.e, number of M2H sessions) will be at the discretion of the health coaches. Sessions may be delivered in-person or utilize technology including text messaging, telephone, e-mail, video chat, app-based self-management etc.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brooke Army Medical Center
Lead Sponsor
University of Utah
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Madigan Army Medical Center
Collaborator
Tripler Army Medical Center
Collaborator
59th Medical Wing
Collaborator
Published Research Related to This Trial
Citations
Effectiveness of mindfulness meditation on pain and quality ...
The findings showed MBSR was effective in reduction of pain severity and the patients who practiced 8 sessions meditation reported significantly lower pain than ...
Effect of Mindfulness-Based Stress Reduction vs Cognitive ...
Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.
Mindfulness and cognitive behavioral therapy may improve ...
Eight weeks of mindfulness or cognitive behavioral therapy were associated with improved pain, physical function and quality of life and ...
The effectiveness of mindfulness-based stress reduction ...
MBSR therapy improves physical function at 8 weeks and 6 months follow-up in CLBP individuals. Further high-quality RCTs are warranted for the long-term effect.
Mindfulness-based Interventions for Chronic Low Back Pain
The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. Conclusions: MBIs ...
Meditation and Mindfulness: Effectiveness and Safety | NCCIH
A 2017 analysis of 30 studies (2,561 participants) found that mindfulness meditation was more effective at decreasing chronic pain than several ...
Meditation-Based Therapy for Chronic Low Back Pain ...
In 10 trials, meditation-based therapies significantly reduced the CLBP pain intensity compared with nonmeditation therapies (standardized mean ...
Mindfulness vs Cognitive Behavioral Therapy for Chronic ...
Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...
Mindfulness Meditation for Chronic Low Back Pain in Older ...
These data will allow a detailed examination of the temporal association of the individual weeks of the 8-week MBSR program with the primary outcomes of pain ...
Telehealth Mindfulness-Based Interventions (MBIs) for ...
Two versions of a telehealth mindfulness-based intervention (MBI) are each more effective than usual care in relieving chronic pain.
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