Comparing Different Types of Physical Therapy for Treating People With a Meniscal Tear and Osteoarthritis (TeMPO)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    860
  • sponsor
    Brigham and Women's Hospital
Updated on 3 March 2022
pain relief
osteoarthritis
x-rays
knee pain
osteophyte
torn meniscus
knee arthritis

Summary

Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Treatments include surgically removing the damaged part of the meniscus; strengthening exercises to improve pain and function; manual therapy including massage and mobilization; acupuncture; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy is no more effective than physical therapy by itself.

While physical therapy alone has been shown to result in similar pain relief as arthroscopic surgery, researchers have not yet done studies to determine what type of physical therapy is best for people with knee arthritis and meniscal tears. In the "TeMPO" Trial, we will be comparing 4 different, non-operative physical therapy regimens in order to gain a better understanding of how physical therapy works and what regimen will best reduce pain and improve function in persons with meniscal tear and osteoarthritis. The four arms in this randomized trial will contain different combinations of therapeutic treatments including in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be completed at home. Subjects in three of the arms will also receive motivational SMS (text) messages intended to improve adherence to the home exercise regimen.

TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to one of the four arms. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help us to understand what aspects of physical therapy actually make people feel better.

Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a home exercise regimen will experience more pain relief than subjects in each of the other arms. Also, we expect that subjects in the arm that receives the home exercise regimen and SMS messages will experience more pain relief than subjects in the arm that receives home exercise without the SMS messages.

Description

Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to address meniscal tears in the presence of knee arthritis. These include surgically removing the damaged part of the meniscus; strengthening exercises; manual therapy including massage and mobilization; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy leads to similar levels of pain relief as physical therapy alone.

While physical therapy appears to be useful in knee osteoarthritis and meniscal tear, research is needed to determine what type of physical therapy is best for people with these conditions. The "TeMPO" Trial will compare 4 different non-operative regimens in order to gain a better understanding of how physical therapy works and to determine which regimen will best reduce participants' pain and improve their function. The four arms in this trial will contain different combinations of therapeutic treatments including in-clinic supervised exercise therapy, in-clinic topical therapies, and exercises to be completed at home. Some of the arms will also receive text messages designed to improve adherence to assigned exercises. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help identify the aspects of physical therapy that make people feel better.

The four arms in the TeMPO study are as follows:

  1. Home Exercise Program
  2. Home Exercise Program + Motivational SMS messages
  3. Home Exercise Program + Motivational SMS messages + In-Clinic topical therapy
  4. Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy

Details
Condition Meniscal Degeneration, Osteoarthritis, Knee
Treatment TeMPO Home Exercise Program, Motivational SMS Messages, In-Clinic Topical Therapy, In-Clinic Exercise Therapy
Clinical Study IdentifierNCT03059004
SponsorBrigham and Women's Hospital
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Knee pain of at least 21 days duration if traumatic; no minimum duration if non-traumatic
Age 45 -85 years
Physician diagnosis of meniscal tear
Evidence on MRI of meniscal tear
Evidence of osteoarthritic changes on imaging: Cartilage damage on MRI, osteophyte or joint space narrowing on X-ray

Exclusion Criteria

KL-Grade 4
Inflammatory arthritis
Prior APM or TKR on index knee; or any surgery on index knee in prior 6 mo
Pregnancy
Contraindication to MRI
Daily use of strong opioids
Intra-articular therapy in last 4 weeks
Non-English speaking
History of dementia
Currently resides in a nursing home
Current claimant of worker's compensation for this condition
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