Stepped Care Management for Lower Back Pain

(SMART LBP Trial)

Not currently recruiting at 3 trial locations

Overseen By Mary Laugesen, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Spine fracture, Pregnancy, Recent surgery, others

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

Compensation: Varies

Number of Visits: 28

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

Who 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

I have lower back pain or a related condition.

I have seen a healthcare provider for lower back pain in the last 30 days.

You are currently serving in the military or are a family member of someone in the military receiving healthcare through a military facility.

Exclusion Criteria

I have undergone pain management procedures in the last 6 months.

My lower back pain is not due to a serious condition like a fracture or cancer.

I have had surgery on my lower back in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive either physical therapy (PT) or Move to Health (M2H) interventions for 6 weeks

6 weeks

Up to 2-3 sessions per week

Phase II Treatment

Non-responders to Phase I are randomized to receive either mindfulness or a combined PT+M2H intervention for 8 weeks

8 weeks

8 individual sessions for mindfulness

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 18 weeks, 6 months, and 12 months

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?

Group I: Phase II: MORE Mindfulness Experimental Treatment 1 Intervention

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.

Group II: Phase II: Combine PT & M2H Experimental Treatment 2 Interventions

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.

Group III: Phase I: Physical Therapy (PT) Experimental Treatment 1 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.

Group IV: Phase I: Move to Health (M2H) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Tripler Army Medical Center

Collaborator

Trials

23

Recruited

27,900+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Published Research Related to This Trial

This study will evaluate the effectiveness of a mobile health (mHealth) program designed to reduce sedentary behavior and increase physical activity among 220 office workers with type 2 diabetes over a 12-month period, potentially improving their health outcomes.

The intervention group will receive real-time feedback and strategies through a smartphone app for 13 weeks, while the control group will continue with usual care, allowing for a comparison of changes in physical activity, glycaemic control, and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a healthcare-based mobile intervention on sedentary patterns, physical activity, mental well-being and clinical and productivity outcomes in office employees with type 2 diabetes: study protocol for a randomized controlled trial. Alòs, F., Colomer, MÀ., Martin-Cantera, C., et al.[2022]

In a cohort study of patients with low back pain undergoing physical therapy, a 2-point change on the Numerical Pain Rating Scale (NPRS) was found to indicate a clinically meaningful improvement, surpassing measurement error.

The study demonstrated that most patients experienced significant pain reduction after 1 and 4 weeks of rehabilitation, with responsiveness metrics showing strong reliability in assessing pain changes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsiveness of the numeric pain rating scale in patients with low back pain. Childs, JD., Piva, SR., Fritz, JM.[2022]

The SMART LBP trial is a multisite study involving military treatment facilities that aims to evaluate the effectiveness of nonpharmacologic treatments for chronic low back pain, focusing on a stepped care model that promotes self-management.

Participants will receive either physical therapy or the Move2Health program initially, and nonresponders will be randomized to additional treatments, including a combination of both or mindfulness-based therapy, to determine the best strategies for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol. Fritz, JM., Rhon, DI., Teyhen, DS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4479890/

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 ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2504811

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.

3. psu.edu psu.edu/news/research/story/mindfulness-and-cognitive-behavioral-therapy-may-improve-chronic-low-back-pain

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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388122000913

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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37942696/

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 ...

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35226059/

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 ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

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- ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00494845

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 ...

10. hsrd.research.va.gov hsrd.research.va.gov/impacts/mbi-pain.cfm

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.