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

198 Participants Needed

Trial Summary

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.

How is the STEPPT treatment for back pain different from other treatments?

The STEPPT treatment for back pain is unique because it likely involves a structured, step-by-step approach to managing pain, potentially incorporating non-drug methods to promote self-management, which is different from traditional treatments that may rely more on medication or standard physiotherapy. ^{1 2 3 4 5}

What is the purpose of this trial?

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.

Research Team

Katrina Monroe, PT, PhD

Principal Investigator

San Diego State University

Sara Gombatto, PT, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Subgrouping low back pain: a comparison of the STarT Back Tool with the Orebro Musculoskeletal Pain Screening Questionnaire. [2022]

2. United States 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. [2022]

3. 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]

4. England 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. [2022]

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

Shoe orthotics for the treatment of chronic low back pain: a randomized controlled pilot study. [2022]