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

NCT ID: NCT03059004

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 879 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2024-12-01

Brief 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.

Detailed 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

Conditions

Meniscal Degeneration; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1. Home Exercise Program

The Home Exercise group receives the TeMPO Home Exercise Program (including a set of weights, a DVD showing how to complete the TeMPO exercises, and a pamphlet outlining instructions on how to complete the exercises and how often should they be done).

Group Type: EXPERIMENTAL

TeMPO Home Exercise Program

Intervention Type: BEHAVIORAL

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

2. Home Exercise Program + SMS Messages

Subjects in this arm receive the TeMPO Home Exercise Program and motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise regimen.

Group Type: EXPERIMENTAL

TeMPO Home Exercise Program

Intervention Type: BEHAVIORAL

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

Motivational SMS Messages

Intervention Type: BEHAVIORAL

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

3. In-Clinic Topical Therapy

Subjects in this arm receive the TeMPO Home Exercise Program, motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise Program, and 14 in-clinic sessions with a trained physical therapist. The therapist will apply topical therapies: ultrasound, gel, and manual therapy.

Group Type: EXPERIMENTAL

TeMPO Home Exercise Program

Intervention Type: BEHAVIORAL

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

Motivational SMS Messages

Intervention Type: BEHAVIORAL

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

In-Clinic Topical Therapy

Intervention Type: BEHAVIORAL

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.

4. In-Clinic Exercise Therapy

Subjects in this arm will receive the TeMPO Home Exercise Program, SMS motivational messages to encourage them to adhere to the TeMPO Home Exercise Program and 14 in-clinic sessions with a trained physical therapist. The therapist will supervise the participant in a rigorous set of strengthening and stretching exercises.

Group Type: EXPERIMENTAL

TeMPO Home Exercise Program

Intervention Type: BEHAVIORAL

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

Motivational SMS Messages

Intervention Type: BEHAVIORAL

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

In-Clinic Exercise Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Motivational SMS Messages

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Neil Katz, MD

Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chuck Washabaugh, PhD

Role: STUDY_CHAIR

National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

University at Buffalo Medical Department

Buffalo, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Katz JN, Collins JE, Bisson L, Jones MH, Irrgang JJ, Selzer F, Safran-Norton CE, Spindler KP, Yang HY, Shrestha S, Bennell KL, Sullivan JK, Kluczynski MA, Arant K, Opare-Addo M, Huizinga JL, Zimmerman Z, Sople D, Tonsoline P, Kale M, Wind WM Jr, Chen AF, Freitas M, Lesniak B, Jordan K, Matzkin EG, Dawson C, Farrow L, Musahl V, Leddy JJ, Martin SD, Losina E. A Randomized Trial of Physical Therapy for Meniscal Tear and Knee Pain. N Engl J Med. 2025 Oct 30;393(17):1694-1703. doi: 10.1056/NEJMoa2503385.

Reference Type: DERIVED

PMID: 41160820 (View on PubMed)

Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program. BMC Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.

Reference Type: DERIVED

PMID: 31684921 (View on PubMed)

Sullivan JK, Irrgang JJ, Losina E, Safran-Norton C, Collins J, Shrestha S, Selzer F, Bennell K, Bisson L, Chen AT, Dawson CK, Gil AB, Jones MH, Kluczynski MA, Lafferty K, Lange J, Lape EC, Leddy J, Mares AV, Spindler K, Turczyk J, Katz JN. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial. BMC Musculoskelet Disord. 2018 Dec 1;19(1):429. doi: 10.1186/s12891-018-2327-9.

Reference Type: DERIVED

PMID: 30501629 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1U01AR071658-01

Identifier Type: NIH

Identifier Source: org_study_id

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