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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up november 2014 to november 2023

Awards & highlights

Study Summary

This trial is testing whether physical therapy in addition to steroid injections is better than just steroid injections for treating adhesive capsulitis (aka frozen shoulder). They think there might not be a difference in outcome and that the extra physical therapy will add extra financial burden with no benefits.

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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Elbow

Secondary outcome measures

Functional outcome based on the Constant shoulder score sheet

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,198,054 Total Patients Enrolled

Scott D Martin, MDPrincipal Investigator - Massachusetts General Hospital

Cedars-Sinai Medical Center

Medical School - Northwestern University

Harvard University, Residency in Otolaryngology and Head and Neck Surgery

2 Previous Clinical Trials

510 Total Patients Enrolled

Media Library

Depot Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02283996 — Phase 4

Frozen Shoulder Research Study Groups: Watchful Waiting with Steroid Injection, Physical Therapy with Steroid Injection

Frozen Shoulder Clinical Trial 2023: Depot Methylprednisolone Highlights & Side Effects. Trial Name: NCT02283996 — Phase 4

Depot Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02283996 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what scenarios is Physiotherapy regularly applied?

"Physiotherapeutic techniques are routinely used to treat ophthalmia, sympathetic and other illnesses such as scalp structure, temporal arteritis, and lupus erythematosus."

Answered by AI

How many participants is this trial set to include?

"Affirmative. The information posted on clinicaltrials.gov verifies that the study is actively recruiting patients, which began recruitment in November 1st 2014 and was last updated on November 13th 2022. 260 participants are needed across one medical centre."

Answered by AI

Is enrollment now open for this experiment?

"Affirmative. Per the clinicaltrials.gov information, this trial is actively seeking participants; it was initially posted on November 1st 2014 and recently updated on November 13th 2022. The research team needs to enroll 260 people in one location for the study to be completed successfully."

Answered by AI

What other research programs have investigated the effectiveness of Physical Therapy?

"Currently, there are 150 concurrent studies exploring the benefits of Physical Therapy. Out of those, 39 have progressed to Phase 3 trials. Although most locations researching this treatment are situated in Houston, Texas; 6845 sites across the United States administer these treatments."

Answered by AI

Has the FDA endorsed Physical Therapy as an effective treatment?

"Our team at Power has assessed physical therapy to be of the utmost safety, scoring it a 3. This is due to this treatment having reached Phase 4 in its clinical trials and being approved for use."

Answered by AI

Recent research and studies

British Journal of Sports MedicineJournal

Physical Examination Tests of the Shoulder: A Systematic Review with Meta-analysis of Individual Tests

Hegedus, E J, A Goode, S Campbell, A Morin, M Tamaddoni, C T Moorman, and C Cook. 2007. “Physical Examination Tests of the Shoulder: A Systematic Review with Meta-analysis of Individual Tests”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsm.2007.038406.

Journal of Orthopaedic & Sports Physical TherapyJournal

Frozen Shoulder: Evidence and a Proposed Model Guiding Rehabilitation

Kelley, Martin J., Phillip W. Mcclure, and Brian G. Leggin. 2009. “Frozen Shoulder: Evidence and a Proposed Model Guiding Rehabilitation”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2009.2916.

Archives of Physical Medicine and RehabilitationJournal

Randomized Controlled Trial for Efficacy of Intra-articular Injection for Adhesive Capsulitis: Ultrasonography-guided Versus Blind Technique

Lee, Hong-Jae, Kil-Byung Lim, Dug-Young Kim, and Kyung-Tae Lee. 2009. “Randomized Controlled Trial for Efficacy of Intra-articular Injection for Adhesive Capsulitis: Ultrasonography-guided Versus Blind Technique”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2009.07.025.

Journal of Shoulder and Elbow SurgeryJournal