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NCT03479502 · ClinicalTrials.gov registry record · Phase 4
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03479502: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT03479502 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03479502, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40 patients will be randomized, with 20 in the control group of 3 intra-articular injections of 40mg Methylprednisolone spaced every two weeks, and 20 in the experimental group of 3 intra-articular injection of 50mg doxycycline spaced every two weeks. Both groups will begin a standardized physical therapy program within a pain-free range of motion 4 weeks after the initiation of treatment. We will prospectively follow patients for one year, with follow-up at 6 weeks, 12 weeks, 6 months, and 12 months after the initiation of treatment. Outcomes will be measured using the American Shoulder and Elbow Score (ASES) and objective measurements of shoulder range of motion, which will be collected by the treating physician. Both the patients and physicians participating in the study will be blinded.
Primary Outcome
The American Shoulder and Elbow Score questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. ASES results are in the 0 to 100 range, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the lower the score, the greater the level of shoulder disability. Transforming the pain and the ADLs domains into the final score relies on the following formula
Interventions
- DRUG Methylprednisolone Injectable Product
- DRUG Doxycycline Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2022-02-08 |
| Phase | Phase 4 |
What the finished NCT03479502 record still lists
NCT03479502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone Injectable Product is the first listed.
NCT03479502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03479502 about?
NCT03479502 is a clinical study titled "Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis". We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40 patients will be randomized, with 20 in the control group of 3 intra-articular injections of 40mg Methylprednisolo...
What is the current status of trial NCT03479502?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2018-03-05. Estimated completion is 2022-02-08.
What interventions are being tested in trial NCT03479502?
The interventions under investigation include: Methylprednisolone Injectable Product (DRUG), Doxycycline Injection (DRUG).
Who is sponsoring clinical trial NCT03479502?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03479502's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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