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

Massachusetts General Hospital · NCT02283996

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
260
US sites recruiting
1
Study start
November 2014
Record last updated
October 27, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Physical Therapy; Depot Methylprednisolone

Conditions: Adhesive Capsulitis; Frozen Shoulder; Shoulder Frozen

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Non-English speaking patients
  • Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)
  • Patients who had previously undergone operative therapy for the condition

Recruiting US locations

  • MGH, Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Scott D Martin, MD · SDMARTIN@partners.org

Study contacts (from the official record)

  • Scott D Martin, MD · 617-732-5329 · sdmartin@partners.org
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Adhesive Capsulitis: Prospective Analysis of Efficacy and… (NCT02283996) | Bored Studies