Guideline-Based Physical Therapy for Lower Back Pain

(RESOLVE Trial)

Overseen By Sara Gorczynski, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emma Beisheim-Ryan

Disqualifiers: Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specific guidelines for physical therapy can reduce pain and disability from low back pain and decrease future healthcare needs. It compares usual care with a new approach that includes additional training for therapists and feedback on treatment success. Individuals currently receiving outpatient physical therapy for low back pain might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative physical therapy approaches that could improve future treatment options.

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.

What prior data suggests that this physical therapy protocol is safe for treating lower back pain?

Research has shown that physical therapy is generally safe for treating low back pain. Studies have found that combining physical therapy with exercises can reduce pain and improve movement. Some reviews mention minor side effects, such as soreness or a temporary increase in pain after exercise, but these are uncommon. Overall, physical therapy is well-tolerated and considered safe for individuals with low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how physical therapy is delivered for lower back pain. Unlike typical treatments that may not always incorporate the latest guidelines, this trial tests a more structured approach by integrating Clinical Practice Guidelines (CPG) with a Psychologically Informed Physical Therapy (PIPT) strategy. This method includes education and feedback loops to ensure therapists are using the best practices consistently. By focusing on both physical and psychological aspects, this approach could potentially lead to better patient outcomes compared to usual care.

What evidence suggests that this trial's treatments could be effective for low back pain?

Research has shown that Psychologically Informed Physical Therapy (PIPT), studied in this trial, can effectively treat low back pain, particularly for those at high risk of poor recovery. Participants may receive PIPT, which uses cognitive-behavioral techniques to improve patient-reported outcomes compared to regular physical therapy. Several randomized trials have demonstrated that PIPT helps patients become more active, even with ongoing low back pain. This approach combines physical therapy with psychological methods to enhance recovery and reduce pain. Overall, evidence suggests PIPT can be a valuable tool in managing low back pain effectively. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for military service members and veterans who are currently receiving outpatient physical therapy for low back pain. It aims to help them reduce pain, disability, and the need for further healthcare.

Inclusion Criteria

I am currently getting physical therapy for low back pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy with adherence to Clinical Practice Guidelines (CPG) for up to 12 weeks

12 weeks

Every two weeks

Follow-up

Participants are monitored for changes in analgesic medication use and healthcare utilization

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview The study tests if following Clinical Practice Guidelines in physical therapy can improve outcomes for low back pain. It also includes training with audit/feedback on psychologically informed practices.

How Is the Trial Designed?

Group I: Usual Care Condition Active Control 1 Intervention

During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines.

Group II: CPG+PIPT Condition Active Control 1 Intervention

An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes

Who Is Running the Clinical Trial?

Emma Beisheim-Ryan

Lead Sponsor

Trials

1

Recruited

4,000+

VA New York Harbor Healthcare System

Collaborator

Trials

25

Recruited

14,400+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Naval Health Research Center

Collaborator

Trials

21

Recruited

177,000+

James A. Haley Veterans Administration Hospital

Collaborator

Trials

21

Recruited

13,200+

Marine Corps Base Camp Pendleton

Collaborator

Trials

4

Recruited

4,500+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Published Research Related to This Trial

Physical therapists must effectively track outcomes for patients with low back pain to monitor treatment effectiveness, and this article reviews various measurement tools to aid in that process.

The article discusses the reliability and validity of common outcome measures, such as the SF-36 and Oswestry Questionnaire, providing practical guidelines for their selection and use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guide to outcomes measurement for patients with low back pain syndromes. Resnik, L., Dobrzykowski, E.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8665872/

Implementation of Psychologically Informed Physical ... They found that PIPT is likely effective for low back pain, especially when it is targeted toward patients who are at high risk of poor outcomes ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590024006461

Psychologically Informed Physical Therapy Management of ... Copsey, et al. Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice?

3. journals.lww.com journals.lww.com/painrpts/fulltext/2020/10000/psychologically_informed_physical_therapy_for.19.aspx

Psychologically informed physical therapy for... : PAIN ... Several randomized trials have been conducted examining the efficacy of PIPT compared to standard physical therapy on important patient-reported outcomes of ...

4. academic.oup.com academic.oup.com/ptj/article/91/5/765/2735762

Psychologically Informed Interventions for Low Back Pain This article is intended to describe how therapists can help patients to return to more-active lifestyles despite persistent LBP.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7808677/

Psychologically informed physical therapy for musculoskeletal ... Randomized trials have examined the efficacy of psychologically informed physical therapy methods including graded activity or graded exposure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6709610/

Effectiveness of physical therapy and exercise on pain ... These results show that physiotherapy combined with medical therapy and exercise leads to better improvements in pain and functional status at three months ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429691/

Impact of Exercise Therapy on Outcomes in Patients with ... Reduction of pain emerged as the primary measured outcome in systematic reviews (81.8%, n = 72), and these studies showed significant improvement rates of 83.0% ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S209525462500016X

Review Benefits and harms of exercise therapy ... Minor adverse events, including post-exercise soreness and temporary pain increases, were reported in less than 31% of reviews, predominantly linked to yoga ...

9. jospt.org jospt.org/doi/10.2519/jospt.2021.0304

Interventions for the Management of Acute and Chronic ... Physical therapists can use exercise training interventions, including specific trunk muscle activation, for patients with acute low back pain (LBP).

10. archives-pmr.org archives-pmr.org/article/S0003-9993(24)00845-1/fulltext

Exercise Therapy for Treatment of Acute Non-specific Low ... Conclusion. Exercise therapy compared with sham/placebo and no treatment may have no clinically relevant effect on pain or functional status in the short term ...