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NCT Number: NCT03059004

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. 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.

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Key information

Conditions

Meniscal Degeneration Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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:

  • Home Exercise Program
  • Home Exercise Program + Motivational SMS messages
  • Home Exercise Program + Motivational SMS messages + In-Clinic topical therapy
  • Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Motivational SMS Messages

Behavioral

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

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.

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.

Primary outcomes

  1. Change in Pain

    Time frame: Randomization to 3 months

    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)

Secondary outcomes

  1. Change in function

    Time frame: Randomization to 3 months

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

  2. Change in quality of life

    Time frame: Randomization to 3 months

    Difference between arms in change in quality of life measured with the EQ-5D scale over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)

  3. Binary treatment failure indicator

    Time frame: Randomization to 3 months

    Difference between arms in treatment failure defined as either not reaching improvement of >=8 points on KOOS Pain or receiving injection or undergoing index knee surgery within three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)

  4. Forty meter fast-paced walk

    Time frame: Randomization to 3 months

    Difference between arms in change in 40 m fast-paced walk (seconds) over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)

  5. 30-second sit to stand

    Time frame: Randomization to 3 months

    Difference between arms in number of repetitions (of sit to stand) over 30 seconds

  6. Strength of quadriceps, hamstrings, gluteus medius

    Time frame: Baseline to 3 months

    Difference between arms in strength (pounds-cm) between arms, measured at three sites (quadriceps, hamstrings, gluteus medius)

  7. Single Leg Balance

    Time frame: Baseline to 3 months

    Difference between arms in number of seconds participant can stand on single leg without moving hands off hips, stepping or stumbling, abducting or flexing hip beyond 30 deg, lifting heel or forefoot off ground.

  8. Durability of pain relief

    Time frame: 3-12 months

    Difference between arms in proportion of subjects who maintain through 12 months the benefit (in KOOS Pain) achieved at 3 months. (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3 )

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston University
  • National Institutes of Health (NIH)
  • State University of New York at Buffalo
  • The Cleveland Clinic
  • University of Melbourne
  • University of Pittsburgh

Registry information

Official study title

Treatment of Meniscal Problems in Osteoarthritis

Acronym: TeMPO

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Feb 23, 2017
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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