NCT03059004: TeMPO

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

Completed NA Last updated 3 July 2025

What this trial tests

NA trial testing TeMPO Home Exercise Program in Meniscal Degeneration in 879 participants. Completed in 1 December 2024.

Timeline

6 February 2018

Primary endpoint
1 October 2023

1 December 2024

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	879
Start date	6 February 2018
Primary completion	1 October 2023
Estimated completion	1 December 2024
Sites	4 locations across United States

Drugs / interventions tested

• TeMPO Home Exercise Program
• Motivational SMS Messages
• In-Clinic Topical Therapy
• In-Clinic Exercise Therapy

Conditions studied

• Meniscal Degeneration — all drugs for Meniscal Degeneration →
• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 45 to 85, any sex, with Meniscal Degeneration or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, et al · · 2019 · cited 17× · PMID 31684921 · DOI 10.1186/s12891-019-2872-x
2. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.
   Sullivan JK, Irrgang JJ, Losina E, Safran-Norton C, et al · · 2018 · cited 10× · PMID 30501629 · DOI 10.1186/s12891-018-2327-9
3. A Randomized Trial of Physical Therapy for Meniscal Tear and Knee Pain.
   Katz JN, Collins JE, Bisson L, Jones MH, et al · · 2025 · cited 2× · PMID 41160820 · DOI 10.1056/nejmoa2503385
4. Methodology and predictive accuracy of the prospective preference assessment for randomized trial enrollment: A literature review.
   Dhani JS, Selzer F, Collins JE, Fox KB, et al · · 2025 · cited 1× · PMID 41367620 · DOI 10.1016/j.ocarto.2025.100696