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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.
Must not have
Subjects who have cognitive deficits limiting ability to follow directions
Subjects who had RSA and require discharge to skilled nursing facility, in-patient rehabilitation placement, or use of home health therapy prior to progressing in recovery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years postoperatively
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am having shoulder replacement for specific shoulder issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have difficulty understanding or following instructions due to cognitive issues.
Select...
I had surgery and need skilled care or rehab before getting better.
Select...
I have had a specific shoulder replacement or surgery that did not involve reversing the joint.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Elbow
Patient-reported functional outcome- Single Assessment Numeric Evaluation score
Postoperative Pain: Numerical Rating Scale
+1 more
Secondary study objectives
Complication rates
Cost of Care
Postoperative Pain Medication Prescription Refills
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,164 Total Patients Enrolled
Orthopedic Research and Education FoundationOTHER
20 Previous Clinical Trials
5,470 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
56 Patients Enrolled for Rotator Cuff Tears
Grant E Garrigues, MDPrincipal InvestigatorRush University Medical Center

Media Library

Home Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03719859 — N/A
Rotator Cuff Tears Research Study Groups: Home Therapy (HT) Group, Physical Therapy (PT) Group
Rotator Cuff Tears 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
~0 spots leftby Dec 2024
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