CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 879 enrolled
Drug / intervention
TeMPO Home Exercise Program +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03059004
NCT03059004N/ACompleted

Treatment of Meniscal Problems in Osteoarthritis

Brigham and Women's Hospital·interventional·Posted Feb 23, 2017·Updated Jul 3, 2025

In Brief

A clinical study evaluating TeMPO Home Exercise Program, Motivational SMS Messages, and 2 other interventions for Meniscal Degeneration and Osteoarthritis, Knee. Completed, enrolled 879 participants across 4 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartFeb 6, 2018
Primary CompletionOct 1, 2023
Study CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 9.4 years ago

Interventions

TeMPO Home Exercise Programbehavioral

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

Motivational SMS Messagesbehavioral

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

In-Clinic Topical Therapybehavioral

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.

In-Clinic Exercise Therapybehavioral

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.