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NCT03059004 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
879
Enrollment target

NCT03059004: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT03059004 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 879 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03059004, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
879 participants
Enrollment target

Study 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 subject

Primary Outcome

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)

Interventions

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

Trial Details

FieldValue
Enrollment Target 879 participants
Start Date 2018-02-06
Est. Completion 2024-12-01
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT03059004 record still lists

NCT03059004 is an interventional study that assigns participants to a tested intervention. The registered 879 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 4 interventions - of which TeMPO Home Exercise Program is the first listed.

NCT03059004 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03059004 about?

NCT03059004 is a clinical study titled "Comparing Different Types of Physical Therapy for Treating People With a Meniscal Tear and Osteoarthritis". 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. Treatm...

What is the current status of trial NCT03059004?

This trial is currently completed. It is a NA study. The enrollment target is 879 participants. The study started on 2018-02-06. Estimated completion is 2024-12-01.

What interventions are being tested in trial NCT03059004?

The interventions under investigation include: TeMPO Home Exercise Program (BEHAVIORAL), Motivational SMS Messages (BEHAVIORAL), In-Clinic Topical Therapy (BEHAVIORAL), In-Clinic Exercise Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT03059004?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03059004's enrollment target sits among peer trials

879 130th of 2000 higher than 1,871 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03059004, the US trial registry maintained by the National Library of Medicine. NCT03059004 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.