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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	45 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03059004
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Brigham and Women's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chuck Washabaugh, PhD
Principal Investigator Affiliation	National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meniscal Degeneration, Osteoarthritis, Knee

Additional Details

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

Arms & Interventions

Arms

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).

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.

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.

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.

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Faith Selzer, PhD

[email protected]

617-525-8617

University at Buffalo Medical Department, Buffalo, New York

Status