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NCT02283996 · ClinicalTrials.gov registry record · Phase 4
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
A Phase 4 study of Frozen Shoulder and Adhesive Capsulitis, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 260
- Enrollment target
- 1
- Study location
NCT02283996 is a Phase 4 study of Frozen Shoulder and Adhesive Capsulitis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 260 participants, above the 130-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (100% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02283996, a Phase 4 study of Frozen Shoulder and Adhesive Capsulitis, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 260 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.
Conditions Studied
Interventions
- OTHER Physical Therapy
- DRUG Depot Methylprednisolone
Study Locations (1)
Massachusetts
- MGH, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2014-11 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02283996
The ClinicalTrials.gov registry entry for NCT02283996 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 3 other Frozen Shoulder trials with a reported enrollment target (100% higher). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Frozen Shoulder appearing as the primary indexed condition, and to 2 interventions - of which Physical Therapy is the first listed.
NCT02283996 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02283996 about?
NCT02283996 is a clinical study titled "Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment". The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective s...
What is the current status of trial NCT02283996?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 260 participants. The study started on 2014-11. Estimated completion is 2027-12.
What conditions does trial NCT02283996 study?
This clinical trial studies the following conditions: Frozen Shoulder, Adhesive Capsulitis, Shoulder Frozen.
What interventions are being tested in trial NCT02283996?
The interventions under investigation include: Physical Therapy (OTHER), Depot Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT02283996?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02283996 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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