Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

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. This study proposes the TeMPO (Treatment of Meniscal Problems in Osteoarthritis) Trial to compare different non-operative physical therapy regimens 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 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, and 4) Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy.  The study hypothesizes 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, and 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.

ELIGIBILITY 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

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

University at Buffalo Medical Department, Buffalo, New York, United States, 14215

Cleveland Clinic, Cleveland, Ohio, United States, 44195

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15237

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03059004?term=NCT03059004&rank=1

Last Reviewed: 05/06/2019