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Physical Therapy for Osteoarthritis (TeMPO Trial)

N/A

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Knee pain of at least 21 days duration if traumatic; no minimum duration if non-traumatic

Physician diagnosis of meniscal tear

Must not have

Daily use of strong opioids

Inflammatory arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Physical therapy side effects may include temporary increased joint pain or muscle soreness following treatment sessions. Topical therapies might cause skin irritation in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My doctor diagnosed me with a torn meniscus.

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I am between 45 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use strong painkillers every day.

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I have inflammatory arthritis.

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I do not speak English.

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I have not had joint injections in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain

Secondary study objectives

30-second sit to stand

Binary treatment failure indicator

Change in function

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: 4. In-Clinic Exercise TherapyExperimental Treatment3 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 TherapyExperimental Treatment3 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 MessagesExperimental Treatment2 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 ProgramExperimental Treatment1 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).

0 / 7Eligibility criteria met