Physical Therapy for Back Pain

Overseen By Sarah E Gullbrand, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prior spinal surgery, Claustrophobia, Pregnancy, 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: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of physical therapy on spinal discs in people with back pain. Back pain is a major issue, especially among Veterans, and the study aims to determine if changes in spinal discs can predict the effectiveness of physical therapy. Participants will engage in a 6-week physical therapy program, including weekly office visits and daily home exercises. It suits individuals with ongoing back pain that limits activity, who have not undergone spinal surgery and are comfortable with MRI scans. As an unphased trial, this study offers a unique opportunity to contribute to understanding back pain treatment and potentially improve participants' conditions.

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 prior data suggests that this physical therapy regimen is safe for back pain?

Research has shown that physical therapy is generally safe and well-tolerated for treating back pain. Many studies have found that exercise and physical therapy can reduce pain and improve mobility. For instance, one review found that exercise therapy significantly relieved pain for 83% of patients. Another study demonstrated that exercise improved movement abilities both in the short term and long term compared to usual care.

No major side effects are commonly reported with physical therapy. Since this trial focuses on physical therapy, a standard treatment, its safety is well-established. Participants can feel confident that physical therapy is a safe option for managing back pain based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this physical therapy approach for back pain because it combines manual therapy with the McKenzie method, which could offer a fresh perspective on managing the condition. Unlike standard treatments that might focus on medications or passive therapies, this regimen actively engages patients in their recovery through supervised exercises and daily home routines. The high-velocity, low amplitude thrust mobilization and repeated motion exercises could potentially improve spinal movement and reduce pain more effectively than traditional methods, offering a promising alternative for back pain sufferers.

What evidence suggests that physical therapy is effective for back pain?

Research has shown that physical therapy, which participants in this trial will receive, can greatly reduce back pain and improve mobility. For example, one study found that exercise relieved pain more effectively than other simple treatments, with a clear drop in pain levels. Another review demonstrated that exercise therapy significantly reduced pain for more than 80% of patients. Physical therapists often use exercises to strengthen core muscles, aiding both sudden and long-term back pain. These findings suggest that physical therapy is a promising option for those dealing with back pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Sarah E. Gullbrand, PhD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

This trial is for individuals with back pain or degenerative disc disease who are stable enough for physical therapy. They must not have had prior spinal surgery, and should be free of metal implants, severe kidney issues, or allergies to MRI contrast. Pregnant individuals and those with certain electronic devices like pacemakers cannot participate.

Inclusion Criteria

You are currently pregnant.

I am experiencing symptoms.

You have an implanted electronic device.

Exclusion Criteria

I have had surgery on my spine before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week physical therapy regimen with weekly in-office visits and daily home exercises

6 weeks

6 visits (in-person), daily home exercises

Follow-up

Participants are monitored for changes in disc health and pain levels after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview The study is looking at how physical therapy affects the spinal discs in patients with back pain by using MRI scans to see if changes in the spine can predict improvement from the therapy.

How Is the Trial Designed?

Group I: Physical therapy Experimental Treatment 1 Intervention

Subjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34580864/

Exercise therapy for chronic low back pain Compared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S277252942500205X

Does preoperative physical therapy/prehabilitation affect ... All included studies reported short-term improvements in pain, functional outcomes, and psychological readiness following prehabilitation. However, these ...

4. 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).

5. mdpi.com mdpi.com/2077-0383/14/17/5942

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% ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1877065722000239

Physical activity and low back pain: A critical narrative review In a recent systematic review, exercise improved function both at the end of treatment and in the long-term compared with usual care. Exercice also reduced work ...

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

Exercise Therapy for Treatment of Acute Non-specific Low ... The primary outcomes were back pain, back-specific functional status, and recovery. Data Extraction. Two review authors independently conducted the study ...