Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
Completed · Phase 4
Conditions studied: Adhesive Capsulitis, Adhesive Capsulitis of Unspecified Shoulder, Frozen Shoulder
In brief
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.
Key facts
- Study ID
- NCT03479502
- Run by
- Vanderbilt University Medical Center
- People needed
- 1
- Starts
- 2018-03-05
- Expected to finish
- 2022-02-08
- Last updated by the study team
- 2024-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 years of age and older,
- diagnosis of stage II adhesive capsulitis as determined by clinical examination of the treating physician, and
- absence of abnormal findings on X-ray.
You may not qualify if…
- allergy to Doxycycline or Methylprednisolone,
- pregnancy,
- diagnosis,
- Inflammatory arthritis or diabetes,
- secondary adhesive capsulitis (history of significant trauma, rotator cuff tear injury, stroke)
- evidence of arthritis on x-ray,
- current infectious disease, and
- any previous treatment for the for adhesive capsulitis of the affected shoulder.
Where it is running
- Vanderbilt Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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