Phase 4
Completed N=1
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
adhesive capsulitis · Adhesive Capsulitis of Unspecified Shoulder · Frozen Shoulder
Source: ClinicalTrials.gov NCT03479502 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Change in American Shoulder and Elbow Score (ASES)
◆ Published Evidence
Highly cited
406citations · ~27 / year
Current review of adhesive capsulitis.
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.
Linked Publications (5)
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Current review of adhesive capsulitis.
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Adhesive capsulitis: a review of current treatment.
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Adhesive capsulitis. A treatment approach.
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Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis?
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Association between Propionibacterium acnes and frozen shoulder: a pilot study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in American Shoulder and Elbow Score (ASES) |
— | — |
| PRIMARY Change in Range of Motion(ROM) Measurements |
— | — |
| SECONDARY Number of Medical Co-morbidities |
— | — |
| SECONDARY Duration of Symptoms |
— | — |
| SECONDARY Changes in Pain |
— | — |
| SECONDARY Pain With Sitting |
— | — |
| SECONDARY Stiffness |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03479502) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.