Physical Therapy for Low Back Pain

Overseen By Kyle R Petrey, DPT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Serious spinal pathology, Neurological disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

57 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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment physical therapy for low back pain?

Research shows that physical therapy can lead to improvements in disability and pain for patients with low back pain, although the effects are often small. Some studies suggest that patients can experience clinical improvement within a few therapy visits, and targeting the hip during therapy may also help reduce pain and disability. ^{1 2 3 4 5}

Is physical therapy safe for humans?

Physical therapy is generally considered safe for humans, as it is a common treatment for various conditions, including low back pain. The research does not report any specific safety concerns related to physical therapy. ^{6 7 8 9 10}

How is physical therapy unique for treating low back pain?

Physical therapy for low back pain is unique because it involves a variety of techniques such as exercise, manual manipulation, and heat application, which can be tailored to individual needs. It also allows for direct access to services, potentially reducing healthcare costs and improving outcomes by starting treatment early. ^{11 12 13 14 15}

What is the purpose of this trial?

Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.

Research Team

Kyle Petrey, DPT

Principal Investigator

BAMC

Eligibility Criteria

This trial is for English-speaking DEERS-eligible individuals aged 18-64 with chronic low back pain lasting over 3 months. Participants must have a disability index of at least 25% and pain intensity score of 3/10 or higher, and commit to six weeks of physical therapy.

Inclusion Criteria

I have had low back pain for more than 3 months.

I can commit to six weeks of physical therapy.

I am eligible for DEERS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a typical physical therapy plan of care to assess improvement in conditioned pain modulation

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Physical therapy

Trial Overview The study tests if standard physical therapy can improve the body's natural pain inhibition (conditioned pain modulation) in people with chronic low back pain. It also examines whether this modulation predicts the success of physical therapy treatment.

Participant Groups

Group I: chronic low back pain Experimental Treatment 1 Intervention

Age 18-64 years with low back pain duration greater than 3 months.

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

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]

In a study of 6,523 patients with low back pain, 42.7% achieved a 30% improvement in disability by the third physical therapy visit, and this increased to 49% by the sixth visit, indicating that many patients benefit from early intervention.

The initial and third visit disability scores were strong predictors of improvement, with excellent diagnostic accuracy (area under the curve values of 0.84 and 0.85) for forecasting significant clinical progress by the sixth visit, highlighting the importance of routine outcome assessments in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. Brennan, GP., Snow, G., Minick, KI., et al.[2023]

Patients with low back pain (LBP) who had symptoms for more than 6 months showed significantly less functional improvement after physical therapy compared to those with symptoms lasting less than 1 month, indicating that longer symptom duration may hinder recovery.

The study found that age, symptom duration, and specific types of exercises (mobilization/manipulation, strengthening, and flexibility) significantly influenced functional improvement, explaining over 55% of the variance in recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in disability following physical therapy intervention for patients with low back pain: dependence on symptom duration. Badke, MB., Boissonnault, WG.[2015]

A systematic review and meta-analysis of six randomized controlled trials involving 387 participants found that hip-targeted physical therapy interventions did not lead to significant reductions in pain or disability for patients with low back pain.

The studies showed a trivial effect size for pain outcomes and a small effect size for disability, indicating that these interventions may not be effective, and all studies had a high risk of bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of hip-targeted physical therapy interventions on low back pain: A systematic review and meta-analysis. Bernet, BA., Peskura, ET., Meyer, ST., et al.[2019]

Early physical therapy (PT) for acute low back pain significantly reduces short-term pain and disability compared to non-PT care, with a moderate effect size based on a meta-analysis of 7 studies involving various participants.

However, early PT does not show significant advantages over delayed PT in terms of pain or disability outcomes, indicating that while early intervention is beneficial compared to no therapy, the timing of PT may not greatly impact long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical therapy timing on patient-reported outcomes for individuals with acute low back pain: A systematic review with meta analysis of randomized controlled trials. McDevitt, AW., Cooper, CG., Friedrich, JM., et al.[2023]

References

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

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

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

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. [2023]

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

Changes in disability following physical therapy intervention for patients with low back pain: dependence on symptom duration. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of hip-targeted physical therapy interventions on low back pain: A systematic review and meta-analysis. [2019]

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

Are Small Effects for Back Pain Interventions Really Surprising? [2017]

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

Physical therapy episodes of care for patients with low back pain. [2022]

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

Distinguishable groups of musculoskeletal low back pain patients and asymptomatic control subjects based on physical measures of the NIOSH Low Back Atlas. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Physical therapy management of low back pain has changed. [2022]

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

Evaluation of Cognitive Behavioral Interventions and Psychoeducation Implemented by Rehabilitation Specialists to Treat Fear-Avoidance Beliefs in Patients With Low Back Pain: A Systematic Review. [2019]

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

Effect of physical therapy timing on patient-reported outcomes for individuals with acute low back pain: A systematic review with meta analysis of randomized controlled trials. [2023]

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

Immediate Physical Therapy Initiation in Patients With Acute Low Back Pain Is Associated With a Reduction in Downstream Health Care Utilization and Costs. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

Pain and functional outcomes after outpatient physiotherapy in patients with low back pain. [2022]

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

Mechanical therapy for low back pain. [2022]

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

Unrestricted Direct Access to Physical Therapist Services Is Associated With Lower Health Care Utilization and Costs in Patients With New-Onset Low Back Pain. [2020]

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

Factors influencing the use of outcome measures for patients with low back pain: a survey of New Zealand physical therapists. [2022]