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Physical Therapy vs Home Exercise for Shoulder Arthritis

N/A

Waitlist Available

Led By Grant E Garrigues, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Subjects who have RSA for cuff tear arthropathy, massive irreparable rotator cuff tear with pseudoparalysis, or primary osteoarthritis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years postoperatively

Awards & highlights

Study Summary

This trial is comparing outcomes of two different types of therapy after reverse shoulder surgery - formal, clinic-based physical therapy vs. surgeon-directed home therapy. Pain, range of motion, function, and other measures will be compared at 6 weeks, 3, 6, 12, and 24 months after surgery. The trial will also look at whether physical therapy is associated with a higher risk of postoperative complications like stress fractures or dislocation.

Who is the study for?

This trial is for individuals who have undergone reverse total shoulder arthroplasty (RSA) due to cuff tear arthropathy, massive irreparable rotator cuff tears, or primary osteoarthritis. Participants must be able to speak, read, and write English without cognitive deficits that limit following directions. They should not require skilled nursing facilities or in-patient rehab post-surgery.Check my eligibility

What is being tested?

The study compares formal clinic-based physical therapy (PT) with surgeon-directed home therapy (HT) after RSA. It measures pain relief, range of motion, and functional outcomes using specific scores over a period up to 24 months postoperatively. The risk of complications like acromial stress fractures or dislocation is also assessed.See study design

What are the potential side effects?

While the trial itself does not involve medication with side effects, there may be risks associated with PT such as increased discomfort or injury during exercises. Home therapy could potentially lead to less optimal recovery if not performed correctly.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having shoulder replacement for specific shoulder issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years postoperatively for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Elbow

Patient-reported functional outcome- Single Assessment Numeric Evaluation score

Postoperative Pain: Numerical Rating Scale

+1 more

Secondary outcome measures

Complication rates

Cost of Care

Postoperative Pain Medication Prescription Refills

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Therapy (PT) GroupExperimental Treatment1 Intervention

Subjects will attend formal physical therapy after surgery.

Group II: Home Therapy (HT) GroupActive Control1 Intervention

Subjects will receive instruction from clinical staff regarding home therapy exercises after surgery.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,331 Total Patients Enrolled

1 Trials studying Shoulder Arthritis

200 Patients Enrolled for Shoulder Arthritis

Orthopedic Research and Education FoundationOTHER

19 Previous Clinical Trials

11,200 Total Patients Enrolled

Grant E Garrigues, MDPrincipal InvestigatorRush University Medical Center

Media Library

Home Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03719859 — N/A

Shoulder Arthritis Research Study Groups: Home Therapy (HT) Group, Physical Therapy (PT) Group

Shoulder Arthritis Clinical Trial 2023: Home Therapy Highlights & Side Effects. Trial Name: NCT03719859 — N/A

Home Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03719859 — 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 numerous sites operating this experiment throughout the state?

"Presently, this trial is running across 7 different clinical sites located in Chicago, Denver and Leonardtown as well as several other locations. To reduce time spent travelling, it's important to select the centre nearest you if you decide to participate."

Answered by AI

Are there any opportunities for patients to get involved with this research endeavor?

"According to clinicaltrials.gov, this medical research is not actively recruiting participants at present time. Despite the study having been posted on January 22nd 2019 and last updated June 30th 2022, it has since concluded its recruitment process; however there are 238 other trials looking for patients now."

Answered by AI

What objectives is this clinical trial attempting to accomplish?

"This clinical trial will be monitored up to two years postoperatively, with its primary outcome being the Patient-reported functional outcome- Single Assessment Numeric Evaluation score. Other key metrics include Postoperative Pain Medication Use Duration, Complication rates and Cost of Care; all these figures are combined in a cost-effectiveness analysis using decision tree modelling."

Answered by AI