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

Who is this study for? Adult patients with idiopathic adhesive capsulitis
What treatments are being studied? Physical Therapy+Depot Methylprednisolone
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Patient must be 18 years or older

• Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder

• Must be amenable to randomization into either cohort

Locations
United States
Massachusetts
MGH, Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Scott D Martin, MD
sdmartin@partners.org
617-732-5329
Time Frame
Start Date: 2014-11
Estimated Completion Date: 2027-12
Participants
Target number of participants: 260
Treatments
Experimental: Physical Therapy with Steroid Injection
Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.
Experimental: Watchful Waiting with Steroid Injection
Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov