STEPPT for Back Pain

(STEPPT PILOT Trial)

Overseen By Jason Van Dyke, MSPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Non-musculoskeletal spine pain, urgent conditions, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to reduce disparities in how Hispanic and Non-Hispanic White patients with spine pain are referred to and follow through with physical therapy. The trial tests a program called STEPPT Pilot, which includes educating healthcare providers, changing referral processes, and offering support to patients, particularly Hispanic patients, to overcome challenges in attending therapy. Participants must have neck or back pain and identify as either Hispanic or Non-Hispanic White. The goal is to improve care by ensuring everyone receives the physical therapy they need. As an unphased trial, this study provides a unique opportunity to contribute to enhancing healthcare equity and access for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the STEPPT intervention is safe for addressing ethnic disparities in physical therapy referrals and adherence?

Research shows that the STEPPT program for back pain is generally easy for people to handle. Studies of similar care methods have shown good results, with many patients reporting improvements in pain and mobility. These methods focus on personalized care, ensuring patients receive treatment tailored to their specific needs. While the research doesn't specifically mention any negative effects, the emphasis on education and customized care suggests a low risk of harm. The program aims to enhance how patients receive and adhere to physical therapy, a non-invasive treatment. This approach typically has fewer side effects than medications or surgeries. Overall, the STEPPT program appears to be a safe option for treating back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEPPT intervention for back pain because it aims to tackle ethnic disparities in healthcare, specifically focusing on improving physical therapy access and adherence for Hispanic patients with spine pain. Unlike traditional treatments that don't address these disparities, STEPPT includes educating providers about the importance of equitable referrals and uses electronic health record (EHR) modifications to streamline culturally tailored patient education materials. Additionally, it offers enhanced patient health navigation to help overcome barriers to attending physical therapy, making it a potentially transformative approach in reducing healthcare inequality.

What evidence suggests that the STEPPT intervention could be effective for reducing ethnic disparities in physical therapy referrals and adherence for spine pain?

This trial will compare the STEPPT intervention with standard care for back pain. Research has shown that the STEPPT program aims to improve referral rates and follow-through with physical therapy for individuals with spine pain, particularly among Hispanic patients. Participants in the STEPPT intervention arm will receive education for healthcare providers and staff about disparities in referrals and the benefits of physical therapy. The program also uses electronic health records (EHR) to automate referrals and provides culturally relevant educational materials. Additionally, it offers enhanced patient support to help Hispanic patients overcome challenges in attending physical therapy. By focusing on these areas, STEPPT is expected to reduce ethnic disparities in referrals and adherence, leading to better outcomes for spine pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Katrina Monroe, PT, PhD

Principal Investigator

San Diego State University

Sara Gombatto, PT, PhD

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for Hispanic and Non-Hispanic White patients experiencing various types of spine pain, including back and neck pain. It's designed to see if a new intervention called STEPPT can improve physical therapy referrals and adherence among these groups.

Inclusion Criteria

Ethnicity/Race: Participants must identify as either Hispanic or Non-Hispanic White ethnicity/race

I have signed a consent to use my health information for research.

Patients seeking care within the designated Federally Qualified Health System Adult or Adult Walk-in primary care clinic

Exclusion Criteria

I do not need immediate medical intervention for a serious condition.

My spine pain is not due to infection, cancer, bladder problems, or pregnancy.

I have not been referred to physical therapy outside my current healthcare system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention

3 months

Intervention Phase

Implementation of the STEPPT intervention, including education of providers, EHR modifications, and enhanced patient health navigation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including qualitative interviews to assess acceptability and potential impact

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• STEPPT Pilot

Trial Overview

The study compares the new STEPPT intervention with standard care over six months. It will look at how well the clinic adopts STEPPT, gather feedback from staff and patients, and measure any changes in ethnic disparities regarding physical therapy referrals.

How Is the Trial Designed?

Group I: STEPPT Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. The goal is to reduce ethnic disparities by improving physical therapy referral and adherence rates for Hispanic patients with spine pain.

Group II: Standard Care (Control) Active Control 1 Intervention

Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention, will be the active comparator arm. Ethnic disparities in referral and adherence rates will be compared between the 3-month baseline period and the 3-month intervention period to estimate the effect size of the pilot STEPPT intervention for reducing ethnic disparities in physical therapy referral and adherence outcomes.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Family Health Centers of San Diego

Collaborator

Trials

9

Recruited

15,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A pilot study involving 28 patients with non-specific chronic low back pain showed that a multimodal treatment (MMT) significantly reduced pain more than usual physiotherapy treatment (UPT), with a moderate effect size of 0.66.

Patients adhered to the treatment well, with over 80% compliance in both groups, indicating that MMT is feasible for further investigation in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect on pain and function of neurophysiological education and sensorimotor retraining compared to usual physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot randomized controlled trial. Wälti, P., Kool, J., Luomajoki, H.[2022]

The STarT Back Tool (SBT) demonstrated excellent concurrent validity when compared to the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) in identifying subgroups of low back pain patients, with a strong correlation score of 0.80 based on a study of 130 patients.

The SBT is shorter and easier to use than the OMPSQ while effectively identifying high-risk patients, making it a practical alternative for clinicians in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subgrouping low back pain: a comparison of the STarT Back Tool with the Orebro Musculoskeletal Pain Screening Questionnaire. Hill, JC., Dunn, KM., Main, CJ., et al.[2022]

In a study of 214 patients undergoing physical therapy for low back pain, the STarT Back Screening Tool (SBT) effectively categorized patients into low, medium, and high-risk groups based on their initial pain and disability levels, with 33.2% low risk, 47.7% medium risk, and 19.2% high risk.

Patients in the high-risk category showed the greatest improvements in pain and disability scores over the course of treatment, suggesting that the SBT can help physical therapists tailor interventions based on individual risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between categorization with the STarT Back Screening Tool and prognosis for people receiving physical therapy for low back pain. Fritz, JM., Beneciuk, JM., George, SZ.[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]

The pilot study involving 50 patients with chronic low back pain demonstrated that custom-made shoe orthotics can significantly reduce pain and disability after 6 weeks of use compared to a wait-list control group.

Improvements in pain and functional health status were maintained at the 12-week follow-up, suggesting that shoe orthotics may provide lasting benefits, although further research with a larger sample size is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoe orthotics for the treatment of chronic low back pain: a randomized controlled pilot study. Cambron, JA., Duarte, M., Dexheimer, J., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06835439

Study Details | NCT06835439 | Development of STEPPT

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9529058/

Evidence-based interventions to treat chronic low back pain

There was moderate evidence that both epidural steroid and lumbar facet injections offer moderate effects on pain. With an onset time of 1 to 2 ...

3.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06549-w

Effectiveness of spinal manipulation and biopsychosocial self ...

Primary outcomes analyses. Average pain over 12 months post-randomization, average low back disability over 12 months post-randomization and ...

4.

bio.as.uky.edu

bio.as.uky.edu/bibcite/reference/3063

Outcome of non-invasive treatment modalities on back pain

There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, ...

5.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1435504/full

Focused extracorporeal shockwave therapy for the ...

The results revealed that all treated patients had significantly reduced pain and improved functional impairment immediately after the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7678800/

Risk-stratified and stepped models of care for back pain ...

In low back pain, the most widely known approach is based on risk stratification, where patients with higher predicted risk of poor outcome are ...

7.

qualitysafety.bmj.com

qualitysafety.bmj.com/content/30/10/825

a stepped-wedge, cluster-randomised trial

Patient-reported outcomes were back pain intensity measured on a 0–10 Numeric Pain Rating Scale, with 0 indicating no pain and 10 the worst possible pain ...

8.

jospt.org

jospt.org/doi/10.2519/jospt.2021.0304

Interventions for the Management of Acute and Chronic ...

Results favored movement control exercise versus control or general exercise after 3 to 4 weeks and after 12 weeks for pain and disability,,, ...

9.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-13-1088

Prevention of low back pain and its consequences among ...

When conducting a stepped wedge design, the intervention period is prolonged. This can be an extra risk factor for a high drop-out rate due ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5115680/

Improving pain care through implementation of the ...

Models to improve pain outcomes have been developed, but not formally implemented in safety net practices where pain is particularly common.