Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
Condition: Adhesive Capsulitis; Adhesive Capsulitis of Unspecified Shoulder; Frozen Shoulder
MeSH terms: Bursitis
Intervention: Methylprednisolone Injectable Product; Doxycycline Injection
Intervention description: 3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks; 3 intra-articular injections of Doxycycline Injection spaced every two weeks
Intervention MeSH terms: Doxycycline; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. The Vanderbilt Investigational Pharmacy will provide the doxycycline and the steroid solutions and will be in charge of patient randomization.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double Blind Masking
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.