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

NCT03059004 | Completed DMC

• 1 other identifier: 1U01AR071658-01
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 4

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.

Conditions

Meniscal Degeneration; Osteoarthritis, Knee

Keywords

physical therapy

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Difference between arms in change in the KOOS Pain score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1. Arm 4 vs. Arm 3)

  Randomization to 3 months

Secondary Outcomes (8)

• Change in function

  Randomization to 3 months

• Change in quality of life

  Randomization to 3 months

• Binary treatment failure indicator

  Randomization to 3 months

• Forty meter fast-paced walk

  Randomization to 3 months

• 30-second sit to stand

  Randomization to 3 months

Study Arms (4)

1. Home Exercise Program

EXPERIMENTAL

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).

Behavioral: TeMPO Home Exercise Program

2. Home Exercise Program + SMS Messages

EXPERIMENTAL

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.

Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages

3. In-Clinic Topical Therapy

EXPERIMENTAL

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.

Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages; Behavioral: In-Clinic Topical Therapy

4. In-Clinic Exercise Therapy

EXPERIMENTAL

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.

Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages; Behavioral: In-Clinic Exercise Therapy

Interventions

TeMPO Home Exercise Program BEHAVIORAL

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

1. Home Exercise Program; 2. Home Exercise Program + SMS Messages; 3. In-Clinic Topical Therapy; 4. In-Clinic Exercise Therapy

Motivational SMS Messages BEHAVIORAL

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

2. Home Exercise Program + SMS Messages; 3. In-Clinic Topical Therapy; 4. In-Clinic Exercise Therapy

In-Clinic Topical Therapy 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.

3. In-Clinic Topical Therapy

In-Clinic Exercise Therapy 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.

4. In-Clinic Exercise Therapy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator
• State University of New York at Buffalo: collaborator
• The Cleveland Clinic: collaborator
• University of Pittsburgh: collaborator
• University of Melbourne: collaborator
• Boston University: collaborator

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University at Buffalo Medical Department

Buffalo, New York, 14215, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (3)

• 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.

  PMID: 41160820 DERIVED

• 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.

  PMID: 31684921 DERIVED

• 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.

  PMID: 30501629 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chuck Washabaugh, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not be appraised of treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School

Model Details: Four arm parallel randomized controlled trial.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: February 6, 2018
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 12 months after publication of primary trial manuscript
• Access Criteria: note to PI, jnkatz@bwh.harvard.edu with rationale, significance analysis plan.

Locations

US (4)