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

Osteoarthritis, Knee Clinical Trial

— TeMPO  

Official title:

Treatment of Meniscal Problems in Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059004
• Other study ID #: 1U01AR071658-01
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: Jeffrey N Katz, MD, MSc
• Phone: 6177325338
• Email: jnkatz[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscal Degeneration
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Motivational SMS Messages
The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University at Buffalo Medical Department	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston University, National Institutes of Health (NIH), State University of New York at Buffalo, The Cleveland Clinic, University of Melbourne, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Difference between arms in change in the KOOS Pain score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1. Arm 4 vs. Arm 3)	Randomization to 3 months
Secondary	Change in function	Difference between arms in change in the KOOS ADL score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)	Randomization to 3 months
Secondary	Change in quality of life	Difference between arms in change in quality of life measured with the EQ-5D scale over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)	Randomization to 3 months
Secondary	Binary treatment failure indicator	Difference between arms in treatment failure defined as either not reaching improvement of >=8 points on KOOS Pain or receiving injection or undergoing index knee surgery within three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)	Randomization to 3 months
Secondary	Forty meter fast-paced walk	Difference between arms in change in 40 m fast-paced walk (seconds) over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)	Randomization to 3 months
Secondary	30-second sit to stand	Difference between arms in number of repetitions (of sit to stand) over 30 seconds	Randomization to 3 months
Secondary	Strength of quadriceps, hamstrings, gluteus medius	Difference between arms in strength (pounds-cm) between arms, measured at three sites (quadriceps, hamstrings, gluteus medius)	Baseline to 3 months
Secondary	Single Leg Balance	Difference between arms in number of seconds participant can stand on single leg without moving hands off hips, stepping or stumbling, abducting or flexing hip beyond 30 deg, lifting heel or forefoot off ground.	Baseline to 3 months
Secondary	Durability of pain relief	Difference between arms in proportion of subjects who maintain through 12 months the benefit (in KOOS Pain) achieved at 3 months. (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3 )	3-12 months