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



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 85
Updated:12/6/2018
Start Date:February 6, 2018
End Date:November 1, 2022
Contact:Jeffrey N Katz, MD, MSc
Email:jnkatz@partners.org
Phone:6177325338

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Treatment of Meniscal Problems in 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.

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

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
We found this trial at
4
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jay Irrgang, PhD, PT
Phone: 412-432-3721
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Jeffrey N Katz, MD
Phone: 617-525-8617
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Morgan Jones, MD, MPH
Phone: 216-444-2924
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Buffalo, New York 14215
Principal Investigator: Leslie Bisson, MD
Phone: 716-829-2561
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