Clinical trial NCT03059004: Comparing Different Types of Physical Therapy for Treating People With a Meniscal Tear and Osteoarthritis
Official title: Treatment of Meniscal Problems in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Meniscal Degeneration
Osteoarthritis, Knee
Keywords: physical therapy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: State University of New York at Buffalo
name: The Cleveland Clinic
name: University of Pittsburgh
name: University of Melbourne
name: Boston University
First posted: 2017-02-23
Enrollment: 879
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four arm parallel randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: 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: 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

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

Primary outcomes:
measure: Change in Pain
timeFrame: Randomization to 3 months
Secondary outcomes:
measure: Change in function
timeFrame: Randomization to 3 months
measure: Change in quality of life
timeFrame: Randomization to 3 months
measure: Binary treatment failure indicator
timeFrame: Randomization to 3 months
measure: Forty meter fast-paced walk
timeFrame: Randomization to 3 months
measure: 30-second sit to stand
timeFrame: Randomization to 3 months
measure: Strength of quadriceps, hamstrings, gluteus medius
timeFrame: Baseline to 3 months
measure: Single Leg Balance
timeFrame: Baseline to 3 months
measure: Durability of pain relief
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Buffalo
country: United States
facility: University at Buffalo Medical Department
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
name: Chuck Washabaugh, PhD
role: STUDY_CHAIR
References:
citation: Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. 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 Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.
citation: Sullivan JK, Irrgang JJ, Losina E, Safran-Norton C, Collins J, Shrestha S, Selzer F, Bennell K, Bisson L, Chen AT, Dawson CK, Gil AB, Jones MH, Kluczynski MA, Lafferty K, Lange J, Lape EC, Leddy J, Mares AV, Spindler K, Turczyk J, Katz JN. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial. BMC Musculoskelet Disord. 2018 Dec 1;19(1):429. doi: 10.1186/s12891-018-2327-9.