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Corticosteroid

Physical Therapy and Steroids for Frozen Shoulder

Phase 4

Recruiting

Led By Scott D Martin, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 not have

Patients who had previously undergone operative therapy for the condition

Non-English speaking patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up november 2014 to november 2023

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two treatments for frozen shoulder: one with physical therapy and steroid injections, and the other with just steroid injections followed by observation. It aims to see if physical therapy offers extra benefits and if the cost is justified. The study focuses on adults with frozen shoulder to find the most effective and economical treatment.

Who is the study for?

Adults over 18 with adhesive capsulitis, also known as frozen shoulder, can join this study. They must understand English and be open to being randomly placed in one of two treatment groups. Pregnant women or those who've had surgery for this condition before cannot participate.

What is being tested?

The trial is testing if physical therapy combined with steroid injections offers better outcomes than just steroid injections followed by observation for treating frozen shoulder. Participants will either receive regular physical therapy and steroids (Arm 1) or only steroids during the inflammation phase plus monitoring (Arm 2).

What are the potential side effects?

Possible side effects include pain at the injection site from the corticosteroids, potential allergic reactions to medication, and discomfort from physical therapy exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with frozen shoulder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for my condition before.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ november 2014 to november 2023

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~november 2014 to november 2023

This trial's timeline: 3 weeks for screening, Varies for treatment, and november 2014 to november 2023 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Elbow

Secondary study objectives

Functional outcome based on the Constant shoulder score sheet

Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Watchful Waiting with Steroid InjectionExperimental Treatment1 Intervention

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.

Group II: Physical Therapy with Steroid InjectionExperimental Treatment2 Interventions

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.

0 / 4Eligibility criteria met