RecruitingPhase 4NCT02283996

Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

Sponsor

Massachusetts General Hospital

Enrollment

260 participants

Start Date

Nov 1, 2014

Study Type

INTERVENTIONAL

Conditions

Adhesive Capsulitis Shoulder Frozen Frozen Shoulder

Summary

The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how effective physical therapy is — and how much it costs — in treating adhesive capsulitis, commonly known as frozen shoulder. Participants are randomly assigned to a physical therapy program or another treatment approach, and their recovery is tracked over time. You may be eligible if... - You are 18 years of age or older - You have been diagnosed with adhesive capsulitis (frozen shoulder) — a painful condition where scar tissue forms in the shoulder joint, causing pain and limited movement - You are willing to be randomly assigned to either treatment group You may NOT be eligible if... - You do not speak English - You are pregnant (women of childbearing potential will be asked to undergo regular pregnancy testing) - You have previously had surgery for frozen shoulder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPhysical Therapy

The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions. Brigham and Women's/Massachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis: http://www.brighamandwomens.org/Patients\_Visitors/pcs/rehabilitationservices/Physical%20Therapy%20Standards%20of%20Care%20and%20Protocols/Shoulder%20-%20Adhesive%20capsulitis.pdf

DRUGDepot Methylprednisolone

40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine