Stepped Care Management for Lower Back Pain

(SMART LBP Trial)

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

850 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Stepped Care Management for Lower Back Pain?

The research suggests that a stepped care model, which includes non-drug treatments like physical therapy and mindfulness, can be effective for managing low back pain by promoting self-management and improving physical functioning. Additionally, using tools like the STarT Back Screening Tool can help tailor treatments to individual needs, potentially improving outcomes. ^{1 2 3 4 5}

Is Stepped Care Management for Lower Back Pain safe for humans?

The research articles reviewed do not provide specific safety data for Stepped Care Management for Lower Back Pain or its related treatments like MORE Mindfulness, Move 2 Health, or Physical Therapy. However, physical therapy is generally considered safe for humans when conducted under professional guidance. ^{6 7 8 9 10}

How is the Move 2 Health (M2H) and Physical Therapy treatment for lower back pain different from other treatments?

The Move 2 Health (M2H) and Physical Therapy treatment for lower back pain is unique because it combines physical therapy with a focus on self-management and regular physical activity, which can improve overall physical function and quality of life. This approach is different from standard treatments as it emphasizes patient engagement and the use of digital tools to support self-care and exercise. ^{11 12 13 14 15}

What is the purpose of this trial?

This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo a subsequent sequential randomization. This will be Phase II of the study intervention. Patients in Phase II will be randomized to receive 1 of 2 treatments (addition of physical therapy or Move 2 Health, whichever one they did not receive OR the MORE Mindfulness intervention). Patients will be followed for 1 year after enrollment.

Research Team

Julie M Fritz, PhD

Principal Investigator

University of Utah

Daniel Rhon, PhD

Principal Investigator

Brooke Army Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

STarT back tool retained its predicting abilities in patients with acute and sub-acute low back pain after a transcultural adaptation and validation to Hebrew. [2021]

2. England 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Implementation of clinical guidelines on physical therapy for patients with low back pain: randomized trial comparing patient outcomes after a standard and active implementation strategy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prognostic ability of STarT Back Screening Tool combined with work-related factors in patients with low back pain in primary care: a prospective study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

If you Build it, Will they Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Responsiveness of the numeric pain rating scale in patients with low back pain. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Responsiveness Analysis of the Subgroups for Targeted Treatment (STarT) Back Screening Tool in Patients With Nonspecific Low Back Pain. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of patients with spinal operation according to functional mobility. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The effects of exercise interventions on physical function tests and glycemic control in adults with type 2 diabetes: A systematic review. [2022]

12. England 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Psychometric properties of 2-minute walk test: a systematic review. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Centers for Medicare and Medicaid Services Policy Regarding Supervised Exercise for Patients With Intermittent Claudication: The Good, the Bad, and the Ugly. [2019]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Selfcare to better manage musculoskeletal pain and chronic disease]. [2022]