← Back to Search

Physical Therapy for Osteoarthritis (TeMPO Trial)

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

TeMPO Trial 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.Check my eligibility

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.See study design

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.

TeMPO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My doctor diagnosed me with a torn meniscus.

Select...

I am between 45 and 85 years old.

TeMPO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain

Secondary outcome measures

30-second sit to stand

Binary treatment failure indicator

Change in function

+5 more

TeMPO 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloOTHER

247 Previous Clinical Trials

48,672 Total Patients Enrolled

1 Trials studying Osteoarthritis

300 Patients Enrolled for Osteoarthritis

Brigham and Women's HospitalLead Sponsor

1,618 Previous Clinical Trials

11,470,850 Total Patients Enrolled

16 Trials studying Osteoarthritis

29,013 Patients Enrolled for Osteoarthritis

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,506,426 Total Patients Enrolled

20 Trials studying Osteoarthritis

4,008 Patients Enrolled for Osteoarthritis

Media Library

TeMPO Home Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT03059004 — N/A

Osteoarthritis Research Study Groups: 4. In-Clinic Exercise Therapy, 3. In-Clinic Topical Therapy, 1. Home Exercise Program, 2. Home Exercise Program + SMS Messages

Osteoarthritis Clinical Trial 2023: TeMPO Home Exercise Program Highlights & Side Effects. Trial Name: NCT03059004 — N/A

TeMPO Home Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03059004 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently any openings to participate in this research?

"Affirmative. Per the information provided on clinicaltrials.gov, this medical experiment is still searching for participants; it was initially posted on February 6th 2018 and edited most recently on September 13th 2022. The study necessitates 860 patients to be recruited from 4 different locations."

Answered by AI

Is this experiment including elderly participants over the age of 85?

"This clinical trial specified an age range for enrollment, which is 45 years old and up to 85."

Answered by AI

To what extent is this experiment impacting patient health?

"To properly complete this clinical trial, 860 participants who meet the set criteria need to be recruited. These prospective patients can find a recruitment site at Brigham and Women's Hospital located in Boston or University of Pittsburgh Medical Center which is situated in Pennsylvania."

Answered by AI

How many research centers are conducting this experiment?

"This study is currently enrolling at 4 clinical sites, located in Boston, Pittsburgh, Cleveland and a few other cities. Choosing the closest location to you will make your participation more convenient by reducing travel requirements."

Answered by AI