The results of arthroscopic capsular release in the treatment of frozen shoulder - two-year follow-up.
Michał Waszczykowski, Jarosław Fabiś
https://pubmed.ncbi.nlm.nih.gov/20675863/Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2025-10-27
260
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
S
Scott D Martin, MD
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Massachusetts General Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Physical therapy + steroid injection | Watchful waiting + steroid injection | Standard care: PT + corticosteroid injection |
|---|---|---|---|
| What it is | Combination of physical therapy and a depot methylprednisolone injection as studied in the trial | Watchful waiting (no structured physical therapy) with a depot methylprednisolone injection as studied in the trial | Use of physical therapy combined with corticosteroid injection is commonly recommended as first‑line treatment for adhesive capsulitis |
| Primary use | To improve shoulder function and reduce symptoms in adhesive capsulitis | To assess the effect of delayed or minimal intervention combined with steroid injection on shoulder outcomes | To restore shoulder range of motion and function in frozen shoulder using combined conservative treatments |
| How it is given or performed | Depot methylprednisolone injection plus protocol‑based physical therapy | Depot methylprednisolone injection without structured physical therapy | Corticosteroid injection typically followed by a course of physical therapy |
| Evidence status | Efficacy under evaluation by the trial; results not posted yet | Efficacy under evaluation by the trial; results not posted yet | Physical therapy combined with corticosteroid injection has shown benefit for improving function and range of motion |
| Important limitations | Results not yet available; comparative benefit and cost‑effectiveness are unknown | No PT may delay functional recovery; trial results pending | Evidence exists mainly from observational and short‑term studies; long‑term comparative effectiveness is less certain |
| Patient impact | Not yet established; trial ongoing | Not yet established; trial ongoing | Demonstrated improvements in pain, function, and range of motion in many patients |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/19270045/Massachusetts General Hospital
Lead Sponsor