Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID02283996

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

Led by Massachusetts General Hospital · Updated on 2025-10-27

260

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for adhesive capsulitis, also known as frozen shoulder, in adults aged 18 and older. This study compares two approaches: one involving physical therapy combined with steroid injections, and the other using steroid injections followed by watchful waiting. The goal is to determine if adding physical therapy significantly improves patient outcomes and if the extra cost is justified. Adhesive capsulitis causes pain and limited shoulder movement due to inflammation and scar tissue formation. Participants are randomly assigned to one of two groups. The first group receives physical therapy alongside steroid injections during the inflammatory phase, specifically 40 mg of depot methylprednisolone with lidocaine. The second group receives only steroid injections during the inflammatory phase, followed by regular observation without physical therapy. Both interventions follow standard care practices, with no experimental treatments involved. During the study, participants will have scheduled follow-up visits over a period extending up to one year. Researchers will assess functional outcomes using standardized questionnaires such as the American Shoulder and Elbow Surgeons Standardized Questionnaire, the Disabilities of the Arm, Shoulder, and Hand (DASH) score, and the Constant Shoulder Score. The study also evaluates patient satisfaction, physical exam findings, and return to athletics. The aim is to monitor recovery, range of motion, and the financial impact of treatments over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be 18 years or older
  • Must meet the definition of adhesive capsulitis as a self-limiting inflammatory shoulder condition causing pain and limited motion
  • Must be willing to be randomized into either treatment group
Not Eligible

You will not qualify if you...

  • Non-English speaking patients
  • Pregnant women; women of childbearing potential will have regular pregnancy testing
  • Patients who have previously had surgery for adhesive capsulitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year

Participants receive either physical therapy combined with steroid injections or steroid injections followed by watchful waiting according to standard care for adhesive capsulitis.

Regular follow-up visits at scheduled intervals during treatment

Follow-up

Duration - Up to 1 year after treatment

Participants are monitored with scheduled visits to assess functional outcomes and recovery over time.

Scheduled visits at regular intervals for outcome assessments

Trial Site Locations

Total: 1 location

1

MGH, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Scott D Martin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Interventions associated with an increased or decreased likelihood of pain reduction and improved function in patients with adhesive capsulitis: a retrospective cohort study.

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