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

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.

Conditions

• Meniscal Degeneration
• Osteoarthritis, Knee

Interventions

BEHAVIORAL

TeMPO Home Exercise Program

This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.

BEHAVIORAL

Motivational SMS Messages

The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.

BEHAVIORAL

In-Clinic Topical Therapy

Subjects will be assigned to a physical therapist and will attend 14 in-clinic topical therapy sessions. Sessions will include application of ultrasound, gel, and manual therapy.

BEHAVIORAL

In-Clinic Exercise Therapy

Subjects will be assigned to a physical therapist and will attend 14 in-clinic exercise and manual therapy sessions. Sessions will include the same exercises from the Home Exercise Program but the in-clinic therapy setting will allow for more personalization.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• State University of New York at Buffalo

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Boston University

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Chuck Washabaugh, PhD · National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-06

Primary Completion

2023-10-01

Completion

2024-12-01

Countries

• United States

Study Locations