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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Treatment of Meniscal Problems in Osteoarthritis

Conditions
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Meniscal Degeneration, Osteoarthritis, Knee

Intervention / Treatment
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* Behavioral: TeMPO Home Exercise Program
* Behavioral: Motivational SMS Messages
* Behavioral: In-Clinic Topical Therapy
* Behavioral: In-Clinic Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Four arm parallel randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Home Exercise Program<br>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<br>* This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.<br>|
| Experimental: 2. Home Exercise Program + SMS Messages<br>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<br>* This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.<br>Behavioral: Motivational SMS Messages<br>* The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.<br>|
| Experimental: 3. In-Clinic Topical Therapy<br>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<br>* This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.<br>Behavioral: Motivational SMS Messages<br>* The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.<br>Behavioral: In-Clinic Topical Therapy<br>* 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.<br>|
| Experimental: 4. In-Clinic Exercise Therapy<br>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<br>* This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.<br>Behavioral: Motivational SMS Messages<br>* The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.<br>Behavioral: In-Clinic Exercise Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | 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) | Randomization to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function | 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) | Randomization to 3 months | 
| Change in quality of life | 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) | Randomization to 3 months | 
| Binary treatment failure indicator | 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) | Randomization to 3 months | 
| Forty meter fast-paced walk | 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) | Randomization to 3 months | 
| 30-second sit to stand | Difference between arms in number of repetitions (of sit to stand) over 30 seconds | Randomization to 3 months | 
| Strength of quadriceps, hamstrings, gluteus medius | Difference between arms in strength (pounds-cm) between arms, measured at three sites (quadriceps, hamstrings, gluteus medius) | Baseline to 3 months | 
| Single Leg Balance | 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. | Baseline to 3 months | 
| Durability of pain relief | 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 ) | 3-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy