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?

The purpose of this research study is to examine the effects of physical therapy on the spinal discs. Back pain is the number one cause of disability in the US, and the spine is the most common location of chronic pain in Veterans. Physical therapy is often very effective at improving patients' back pain, but it does not work for everyone, and it is not understood how physical therapy alters the tissues within the spine. With this research the investigators hope to learn if the investigative team can measure changes to the spinal discs on MRI scans that might predict if a patient's back pain will improve with physical therapy or not.

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+