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

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ClinicalTrials.gov Identifier: NCT03059004
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
State University of New York at Buffalo
The Cleveland Clinic
University of Pittsburgh
University of Melbourne
Boston University
Information provided by (Responsible Party):
Jeffrey Neil Katz, MD, Brigham and Women's Hospital

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.


Condition or disease Intervention/treatment Phase
Meniscal Degeneration Osteoarthritis, Knee Behavioral: TeMPO Home Exercise Program Behavioral: Motivational SMS Messages Behavioral: In-Clinic Topical Therapy Behavioral: In-Clinic Exercise Therapy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Four arm parallel randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will not be appraised of treatment arm.
Primary Purpose: Treatment
Official Title: Treatment of Meniscal Problems in Osteoarthritis
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Gelusil

Arm Intervention/treatment
Experimental: 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).
Behavioral: 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.

Experimental: 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.
Behavioral: 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.

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

Experimental: 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.
Behavioral: 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.

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

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.

Experimental: 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.
Behavioral: 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.

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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 )



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059004


Contacts
Contact: Jeffrey N Katz, MD, MSc 6177325338 jnkatz@partners.org
Contact: Faith Selzer, PhD 6175258301 fselzer@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Faith Selzer, PhD    617-525-8617    fselzer@bwh.harvard.edu   
Contact: James K Sullivan, BA    617 732 4313    jsullivan76@bwh.harvard.edu   
Principal Investigator: Jeffrey N Katz, MD         
United States, New York
University at Buffalo Medical Department Recruiting
Buffalo, New York, United States, 14215
Contact: Melissa Kluczynski, MS    716-829-2561    mk67@buffalo.edu   
Principal Investigator: Leslie Bisson, MD         
Principal Investigator: John Leddy, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jen Turczyk    216-444-2924    turczyk@ccf.org   
Principal Investigator: Morgan Jones, MD, MPH         
Sub-Investigator: Kurt Spindler, MD         
Sub-Investigator: Elaine Husni, MD, MPH         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Jill Tarr, LCSW, ACSW    412-432-3721    tarrja@upmc.edu   
Principal Investigator: Jay Irrgang, PhD, PT         
Sub-Investigator: Aaron Mares, MD         
Sub-Investigator: Ale Gil, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Institutes of Health (NIH)
State University of New York at Buffalo
The Cleveland Clinic
University of Pittsburgh
University of Melbourne
Boston University
Investigators
Study Chair: Chuck Washabaugh, PhD National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)

Responsible Party: Jeffrey Neil Katz, MD, Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03059004     History of Changes
Other Study ID Numbers: 1U01AR071658-01 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Neil Katz, MD, Brigham and Women's Hospital:
physical therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TEMPO
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs