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Physical Therapy for Back Pain

N/A

Waitlist Available

Led By Sarah E. Gullbrand, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

acute kidney injury

chronic severe kidney disease

Must not have

Documented history of prior spinal surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if physical therapy can help improve back pain by measuring changes in the spinal discs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Physical therapy may cause temporary soreness or discomfort in some patients as they perform exercises designed to improve their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have sudden kidney damage.

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I have a long-term severe kidney problem.

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My body has trouble removing certain MRI contrast dyes.

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I have kidney problems that existed before my current treatment.

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I have low back pain that limits my activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my spine before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Disc T1 relaxation time

Change in Disc T2 relaxation time

Change in Lumbar Range of Motion

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Physical therapyExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1280

0 / 6Eligibility criteria met