Study Summary
This trial will help us to understand how physical therapy works and what protocol is best for people with knee arthritis and meniscal tears.
Eligible Conditions
- Osteoarthritis, Knee
- Meniscal Degeneration
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 3-12 months
3-12 months
Durability of pain relief
Baseline to 3 months
Single Leg Balance
Strength of quadriceps, hamstrings, gluteus medius
Randomization to 3 months
30-second sit to stand
Binary treatment failure indicator
Change in Pain
Change in function
Change in quality of life
Forty meter fast-paced walk
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
3. In-Clinic Topical Therapy
1 of 4
1. Home Exercise Program
1 of 4
2. Home Exercise Program + SMS Messages
1 of 4
4. In-Clinic Exercise Therapy
1 of 4
Experimental Treatment
860 Total Participants · 4 Treatment Groups
Primary Treatment: Motivational SMS Messages · No Placebo Group · N/A
3. In-Clinic Topical TherapyExperimental Group · 3 Interventions: In-Clinic Topical Therapy, TeMPO Home Exercise Program, Motivational SMS Messages · Intervention Types: Behavioral, Behavioral, Behavioral
1. Home Exercise Program
Behavioral
Experimental Group · 1 Intervention: TeMPO Home Exercise Program · Intervention Types: Behavioral2. Home Exercise Program + SMS MessagesExperimental Group · 2 Interventions: TeMPO Home Exercise Program, Motivational SMS Messages · Intervention Types: Behavioral, Behavioral
4. In-Clinic Exercise TherapyExperimental Group · 3 Interventions: TeMPO Home Exercise Program, Motivational SMS Messages, In-Clinic Exercise Therapy · Intervention Types: Behavioral, Behavioral, Behavioral
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-12 months
Who is running the clinical trial?
University of PittsburghOTHER
1,601 Previous Clinical Trials
6,285,075 Total Patients Enrolled
9 Trials studying Osteoarthritis, Knee
2,812 Patients Enrolled for Osteoarthritis, Knee
Brigham and Women's HospitalLead Sponsor
1,472 Previous Clinical Trials
9,734,405 Total Patients Enrolled
11 Trials studying Osteoarthritis, Knee
2,613 Patients Enrolled for Osteoarthritis, Knee
The Cleveland ClinicOTHER
942 Previous Clinical Trials
1,407,382 Total Patients Enrolled
6 Trials studying Osteoarthritis, Knee
1,125 Patients Enrolled for Osteoarthritis, Knee
State University of New York at BuffaloOTHER
210 Previous Clinical Trials
43,530 Total Patients Enrolled
University of MelbourneOTHER
149 Previous Clinical Trials
1,269,220 Total Patients Enrolled
7 Trials studying Osteoarthritis, Knee
1,829 Patients Enrolled for Osteoarthritis, Knee
National Institutes of Health (NIH)NIH
2,419 Previous Clinical Trials
24,556,906 Total Patients Enrolled
10 Trials studying Osteoarthritis, Knee
1,584 Patients Enrolled for Osteoarthritis, Knee
Boston UniversityOTHER
414 Previous Clinical Trials
10,026,967 Total Patients Enrolled
8 Trials studying Osteoarthritis, Knee
4,850 Patients Enrolled for Osteoarthritis, Knee
Chuck Washabaugh, PhDStudy ChairNational Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Physicians use a variety of methods to diagnose meniscal tears
A recent MRI study looked at the evidence of meniscal tears in the knee
MRI scans and X-rays can be used to look for evidence of osteoarthritis in a person's joints
If you are experiencing knee pain for at least 21 days, regardless of the cause, it is classified as knee pain
About The Reviewer
Michael Gill - B. Sc.
First Published: October 3rd, 2021
Last Reviewed: November 17th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Massachusetts | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Brigham and Women's Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
References
- Sullivan, James K., James J. Irrgang, Elena Losina, Clare Safran-Norton, Jamie Collins, Swastina Shrestha, Faith Selzer, et al.. 2018. “The Tempo Trial (treatment of Meniscal Tears in Osteoarthritis): Rationale and Design Features for a Four Arm Randomized Controlled Clinical Trial”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-018-2327-9.
- Safran-Norton, Clare E., James K. Sullivan, James J. Irrgang, Hannah M. Kerman, Kim L. Bennell, Gary Calabrese, Leigh Dechaves, et al.. 2019. “A Consensus-based Process Identifying Physical Therapy and Exercise Treatments for Patients with Degenerative Meniscal Tears and Knee OA: The Tempo Physical Therapy Interventions and Home Exercise Program”. BMC Musculoskeletal Disorders. Springer Science and Business Media LLC. doi:10.1186/s12891-019-2872-x.
- Jeffrey Neil Katz, MD 2018. "Comparing Different Types of Physical Therapy for Treating People With a Meniscal Tear and Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03059004.
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