Physical Therapy for Osteoarthritis

(TeMPO Trial)

No longer recruiting at 3 trial locations

Overseen By Faith Selzer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Strong opioids

Disqualifiers: Inflammatory arthritis, Pregnancy, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best physical therapy methods for individuals with knee osteoarthritis and meniscal tears (a tear in the knee's cartilage). Researchers compare four different therapy plans: the TeMPO Home Exercise Program (a home-based exercise regimen), in-clinic exercise therapy, in-clinic topical therapy, and motivational text messages to boost adherence. The goal is to determine which combination most effectively reduces pain and improves knee function. Individuals with a doctor's diagnosis of a meniscal tear and signs of knee osteoarthritis on imaging may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to explore innovative therapy combinations that could enhance quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using strong opioids daily or have had intra-articular therapy in the last 4 weeks, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have shown that physical therapy and exercise are safe for individuals with knee osteoarthritis, including those with meniscal tears. Research indicates that exercise therapy is a well-tolerated treatment option that helps manage pain and improve function without major side effects.

For exercise therapies conducted in clinics, studies confirm their safety and effectiveness in treating knee osteoarthritis. These therapies are often recommended because they are non-invasive and carry a low risk of side effects.

Topical treatments, such as creams or gels applied to the skin, are also safe and have fewer side effects compared to oral medications, particularly concerning stomach-related issues.

Motivational text messages, used to encourage adherence to exercise routines, have been tested and are safe. They effectively help patients manage their condition by promoting regular physical activity.

Overall, the treatments tested in this trial have a strong safety record based on previous research. Participants can expect these therapies to be safe with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TeMPO Home Exercise Program for osteoarthritis because it offers a structured, at-home physical therapy routine that includes weights, a detailed instructional DVD, and pamphlets. This program goes beyond typical exercise routines by incorporating motivational SMS messages, which aim to boost adherence and engagement. Additionally, some participants benefit from in-clinic sessions where therapists provide personalized guidance and apply topical therapies like ultrasound and gel, potentially enhancing the benefits of the exercises. Unlike many standard care options that focus solely on pain relief, this approach emphasizes building strength and flexibility, which could lead to more sustainable improvements in joint function.

What evidence suggests that this trial's physical therapy regimens could be effective for knee osteoarthritis and meniscal tears?

Research has shown that physical therapy can be as effective as surgery for treating knee osteoarthritis with meniscal tears. Home exercises can significantly relieve pain and improve knee function. In this trial, participants in the Home Exercise Program arm will receive the TeMPO Home Exercise Program. Another arm, Home Exercise Program + SMS Messages, will include motivational text messages to encourage adherence to the exercise regimen.

Studies also indicate that exercising in a clinic can help manage knee pain, and combining these with home exercises might enhance the benefits. Participants in the In-Clinic Exercise Therapy arm will receive both the TeMPO Home Exercise Program and in-clinic sessions with a physical therapist. For treatments applied directly to the skin, evidence supports that gels can effectively reduce pain and stiffness. The In-Clinic Topical Therapy arm will include these topical therapies alongside the TeMPO Home Exercise Program.

While motivational text messages have shown mixed results, some studies suggest they might help people stick to their exercise routines and manage pain better. Overall, each part of the TeMPO program has shown promise in improving symptoms of knee osteoarthritis. ^{1 3 6 7 8}

Who Is on the Research Team?

Chuck Washabaugh, PhD

Principal Investigator

National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)

Are You a Good Fit for This Trial?

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

Evidence on MRI of meniscal tear

Evidence of osteoarthritic changes on imaging: Cartilage damage on MRI, osteophyte or joint space narrowing on X-ray

I have had knee pain for at least 21 days due to an injury, or any duration if not from an injury.

Exclusion Criteria

Current claimant of worker's compensation for this condition

Contraindication to MRI

Currently resides in a nursing home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of four physical therapy regimens, including home exercises, SMS messages, in-clinic topical therapy, and in-clinic exercise therapy

12 weeks

14 in-clinic sessions for some arms

Follow-up

Participants are monitored for changes in pain, function, and quality of life

3 months

Long-term Follow-up

Participants are monitored for durability of pain relief and treatment outcomes

9 months

What Are the Treatments Tested in This Trial?

Interventions

• In-Clinic Exercise Therapy
• In-Clinic Topical Therapy
• Motivational SMS Messages
• TeMPO Home Exercise Program

Trial Overview

The TeMPO Trial compares four non-surgical physical therapy regimens to see which best reduces pain and improves function in people with meniscal tears and osteoarthritis. It includes in-clinic exercises, topical therapies, home exercises and motivational texts. One group will receive placebo treatments to identify effective therapy aspects.

How Is the Trial Designed?

Group I: 4. In-Clinic Exercise Therapy Experimental Treatment 3 Interventions

Subjects in this arm will receive the TeMPO Home Exercise Program, SMS motivational messages to encourage them to adhere to the TeMPO Home Exercise Program and 14 in-clinic sessions with a trained physical therapist. The therapist will supervise the participant in a rigorous set of strengthening and stretching exercises.

Group II: 3. In-Clinic Topical Therapy Experimental Treatment 3 Interventions

Subjects in this arm receive the TeMPO Home Exercise Program, motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise Program, and 14 in-clinic sessions with a trained physical therapist. The therapist will apply topical therapies: ultrasound, gel, and manual therapy.

Group III: 2. Home Exercise Program + SMS Messages Experimental Treatment 2 Interventions

Subjects in this arm receive the TeMPO Home Exercise Program and motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise regimen.

Group IV: 1. Home Exercise Program Experimental Treatment 1 Intervention

The Home Exercise group receives the TeMPO Home Exercise Program (including a set of weights, a DVD showing how to complete the TeMPO exercises, and a pamphlet outlining instructions on how to complete the exercises and how often should they be done).

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

State University of New York at Buffalo

Collaborator

Trials

279

Recruited

52,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Melbourne

Collaborator

Trials

193

Recruited

1,287,000+

Published Research Related to This Trial

A study involving 80 patients with knee osteoarthritis showed that both home exercise programs significantly improved knee range of motion, muscle strength, and overall function, as measured by various health indices.

However, patients who received guidance from a physiotherapist experienced greater improvements compared to those who followed an exercise brochure alone, highlighting the added value of professional support in home exercise therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effectiveness of the home exercise program and the home exercise program taught by physiotherapist in knee osteoarthritis. Yilmaz, M., Sahin, M., Algun, ZC.[2019]

Participants with knee osteoarthritis who attended more physical therapy (PT) visits showed significant improvements in overall knee function and pain, with benefits lasting up to 8 months after treatment, based on a study of 259 individuals.

In contrast, the use of an internet-based exercise training (IBET) program did not lead to significant improvements in any measured outcomes, suggesting that traditional PT may be more effective for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Level of participation in physical therapy or an internet-based exercise training program: associations with outcomes for patients with knee osteoarthritis. Pignato, M., Arbeeva, L., Schwartz, TA., et al.[2019]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40669904/

Effectiveness of exercise therapy in patients with knee ...

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2.

jamanetwork.com

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Implementation of Group Physical Therapy for Knee ...

The estimated rate of patients reporting that their ability to deal with knee pain problems was better at the last than the first class was 53.8 ...

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sciencedirect.com

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A RANDOMIZED CLINICAL CONTROL TRIAL

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bmj.com/content/391/bmj-2025-085242

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pubmed.ncbi.nlm.nih.gov

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Objective: To assess the efficacy and safety of various exercise modalities as therapeutic interventions for managing knee osteoarthritis.

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sciencedirect.com

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Fundamentals of osteoarthritis. Rehabilitation: Exercise, ...

Robust evidence based on randomized clinical trials supports exercise with education and diet as core treatments for OA.

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jospt.org

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Physical Activity and Exercise Therapy Benefit More Than ...

Exercise therapy is a safe and effective solution for managing both OA and a range of other chronic conditions that does not require potentially ...