CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1 enrolled
Drug / intervention
Methylprednisolone Injectable Product +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03479502
NCT03479502Phase 4Completed

Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis

Vanderbilt University Medical Center·interventional·Posted Mar 27, 2018·Updated Jan 18, 2024

In Brief

A Phase 4 clinical trial evaluating Methylprednisolone Injectable Product and Doxycycline Injection for Adhesive Capsulitis and 2 related conditions. Completed, enrolled 1 participant across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartMar 5, 2018
Primary CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.3 years ago

Interventions

Methylprednisolone Injectable Productdrug

3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks

Doxycycline Injectiondrug

3 intra-articular injections of Doxycycline Injection spaced every two weeks