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

Conditions

• Adhesive Capsulitis
• Frozen Shoulder
• Shoulder Frozen

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Physical Therapy — OTHER
  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
• Depot Methylprednisolone — DRUG
  40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine

Study Details

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.

Key Dates

Start date

Nov 30, 2014

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire [ Time Frame: November 2014 to November 2023 ]

Central Contacts

• Scott D Martin, MD
  617-732-5329
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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