Physical Therapy for Osteoarthritis
(TeMPO Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Chuck Washabaugh, PhD
Principal Investigator
National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
Eligibility Criteria
This trial is for adults aged 45-85 with knee pain from a meniscal tear and osteoarthritis, confirmed by MRI or X-ray. Candidates must have had knee pain for at least 21 days if it's due to injury. Exclusions include inflammatory arthritis, recent knee surgery, pregnancy, MRI contraindications, strong opioid use, recent joint therapy, nursing home residents, dementia history or worker's compensation claimants.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- In-Clinic Exercise Therapy (Behavioral Intervention)
- In-Clinic Topical Therapy (Behavioral Intervention)
- Motivational SMS Messages (Behavioral Intervention)
- TeMPO Home Exercise Program (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Dr. William Curry
Brigham and Women's Hospital
Chief Medical Officer
MD from Columbia University College of Physicians and Surgeons
Dr. Scott Schissel
Brigham and Women's Hospital
Chief Executive Officer since 2021
MD from Columbia University College of Physicians and Surgeons
State University of New York at Buffalo
Collaborator
Dr. Jonathan Slonin
State University of New York at Buffalo
Chief Medical Officer since 2020
MD from University of Miami, MBA from George Washington University
Stacy Knapper
State University of New York at Buffalo
Chief Executive Officer since 2023
BSEE from University of Puerto Rico-Mayagüez, MS in Management from Rensselaer Polytechnic Institute
National Institutes of Health (NIH)
Collaborator
Dr. Jeanne Marrazzo
National Institutes of Health (NIH)
Chief Medical Officer
MD from University of California, Los Angeles
Dr. Jay Bhattacharya
National Institutes of Health (NIH)
Chief Executive Officer
MD, PhD from Stanford University
Boston University
Collaborator
Sophie Kornowski
Boston University
Chief Executive Officer since 2022
MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University
Dr. Patrizia Cavazzoni
Boston University
Chief Medical Officer
MD from McGill University
The Cleveland Clinic
Collaborator
David Peter
The Cleveland Clinic
Chief Medical Officer
MD, board-certified in Hospice and Palliative Medicine
Tomislav Mihaljevic
The Cleveland Clinic
Chief Executive Officer since 2018
MD from University of Zagreb School of Medicine
University of Pittsburgh
Collaborator
David Apelian
University of Pittsburgh
Chief Executive Officer since 2019
PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University
Pamela D. Garzone
University of Pittsburgh
Chief Medical Officer
PhD in Clinical Science from the University of Pittsburgh
University of Melbourne
Collaborator
Dr. Krassimira
University of Melbourne
Chief Medical Officer since 2023
MD certified in Anaesthesiology and Intensive Care
Professor Duncan Maskell
University of Melbourne
Chief Executive Officer since 2018
Master of Arts and Doctor of Philosophy from the University of Cambridge