NCT02283996 Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
| NCT ID | NCT02283996 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Adhesive Capsulitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2014-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 260 participants in total. It began in 2014-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Scott D Martin, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT02283996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adhesive Capsulitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02283996 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02283996 currently recruiting?
Yes, NCT02283996 is actively recruiting participants. Contact the research team at sdmartin@partners.org for enrollment information.
Where is the NCT02283996 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT02283996 clinical trial?
NCT02283996 is sponsored by Massachusetts General Hospital. The principal investigator is Scott D Martin, MD at Massachusetts General Hospital. The trial plans to enroll 260 participants.