Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: Orthopedic Research and Education Foundation
• Treatments: Doxycycline; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.