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

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

4039 Participants Needed

Trial Summary

What is the purpose of this trial?

The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.

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 data supports the effectiveness of this treatment for lower back pain?

Research shows that using clinical guidelines in physical therapy for lower back pain can improve patient outcomes, such as physical functioning and coping strategies. Tracking outcomes helps therapists monitor and enhance the effectiveness of treatments for lower back pain. ^{1 2 3 4 5}

Is guideline-based physical therapy for lower back pain safe for humans?

Guideline-based physical therapy, which includes exercises and advice, is generally considered safe for managing lower back pain. It is recommended as a first-line treatment in various guidelines and is associated with improved function and reduced disability. ^{6 7 8 9 10}

How is guideline-based physical therapy for lower back pain different from other treatments?

Guideline-based physical therapy for lower back pain is unique because it follows specific clinical guidelines to tailor therapeutic exercises to each patient's needs, focusing on either motor control or general exercise approaches. This personalized approach aims to improve outcomes by adhering to evidence-based practices, unlike some other treatments that may not follow such structured guidelines. ^{2 7 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Guide to outcomes measurement for patients with low back pain syndromes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Physical therapy for patients with low back pain in Germany: a survey of current practice. [2021]

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

Therapeutic Alliance: Patients' Expectations Before and Experiences After Physical Therapy for Low Back Pain-A Qualitative Study With 6-Month Follow-Up. [2021]

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

Does the implementation of clinical practice guidelines for low back and neck pain by physical therapists improve patient outcomes? A systematic review. [2022]

5. 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]

6. Scotland pubmed.ncbi.nlm.nih.gov

Physiotherapists' use of advice and exercise for the management of chronic low back pain: a national survey. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Exercise Parameters, Considerations and Recommendations for the Treatment of Non-Specific Low Back Pain: International DELPHI Study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Development of a guideline for rehabilitation of patients with low back pain-- phase 2: analysis of data of the classification of therapeutic procedures]. [2019]

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

Physical impairment index: reliability, validity, and responsiveness in patients with acute low back pain. [2015]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Physical Therapy Approaches in the Treatment of Low Back Pain. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Management of low back pain: Treatment provision within private practice in the UK in the context of clinical guidelines. [2022]

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

Core stabilization exercise prescription, part 2: a systematic review of motor control and general (global) exercise rehabilitation approaches for patients with low back pain. [2022]

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

Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. [2023]