Evaluating physical therapy and steroid injections for frozen shoulder treatment
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
PHASE4 · Massachusetts General Hospital · NCT02283996
This study is testing whether combining physical therapy with steroid injections helps people with frozen shoulder feel better compared to just getting steroid injections and waiting to see what happens.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02283996 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the effectiveness and financial implications of physical therapy combined with steroid injections versus steroid injections followed by watchful waiting in patients diagnosed with adhesive capsulitis, commonly known as frozen shoulder. Participants aged 18 and older will be randomized into two groups: one receiving physical therapy and corticosteroid injections, and the other receiving only corticosteroid injections with subsequent observation. The study will assess patient outcomes over a year to determine if the additional costs of physical therapy are justified. The research follows standard care protocols without introducing experimental treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 or older diagnosed with adhesive capsulitis who are willing to participate in randomization.
Not a fit: Patients who have previously undergone surgery for adhesive capsulitis or are non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for adhesive capsulitis, potentially improving patient outcomes and reducing unnecessary healthcare costs.
How similar studies have performed: While similar studies have explored treatment options for adhesive capsulitis, this specific comparison of physical therapy versus watchful waiting with steroid injections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- MGH, Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Scott D Martin, MD — Massachusetts General Hospital
- Study coordinator: Scott D Martin, MD
- Email: sdmartin@partners.org
- Phone: 617-732-5329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adhesive Capsulitis, Frozen Shoulder, Shoulder Frozen, Physical Therapy, Corticosteroid Injections, Hydrodilation, Hydro-dilation, Watchful Waiting, Prospective