Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | January 5, 2018 |
| End Date: | June 2021 |
| Contact: | Rosemary A Sanders, BA |
| Email: | rosemary.a.sanders@vanderbilt.edu |
| Phone: | 615-322-7126 |
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.
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.
Adhesive capsulitis, also known as frozen shoulder, is a common condition of the shoulder
joint affecting 2-5% of the adult population and characterized by progressive, painful loss
of both passive and active range of motion of shoulder [1,2]. Individuals affected by this
condition find it increasingly difficult to perform activities of daily living that require
overhead movement or rotation of the affected shoulder. The natural history of frozen
shoulder follows a predictable progression of symptoms, lasting from 9-24 months before
complete resolution, and results in significant loss of productivity and quality of life for
those affected [3]. Despite the significant number of patients affected by adhesive
capsulitis and the extensive literature focused on the progression and natural history of the
condition, the true underlying etiology remains poorly understood. In light of this poor
understanding of the condition, it is not surprising that a number of conservative and
invasive modalities exist as accepted treatments. These include non-steroidal
anti-inflammatory drugs (NSAIDS), oral steroids, intra-articular steroid injections, Physical
Therapy (PT), and benign neglect as well as more invasive treatments such as hydroxylation,
manipulation under anesthesia, and arthroscopic capsular release [2]. These treatments have
all be shown to have short-term benefit in pain relief, but none have proven to be superior
nor alter the long-term natural history of adhesive capsulitis.
Over the past decade, however, there has been a growing body of literature suggesting that
Propionibacterium acnes infection may play a significant role in a variety of pathological
conditions affecting the native shoulder, most notably frozen shoulder [4,5]. Our goal is to
employ a treatment strategy focused on eradicating P acnes infection as a conservative
treatment of adhesive capsulitis. Through this project, we aim to complete a prospective
randomized pilot study to examine the hypothesis that administration of intra-articular
antibiotics effective against P acnes will prove to be a superior treatment of adhesive
capsulitis as compared to current gold standard of intraarticular steroid injection.
joint affecting 2-5% of the adult population and characterized by progressive, painful loss
of both passive and active range of motion of shoulder [1,2]. Individuals affected by this
condition find it increasingly difficult to perform activities of daily living that require
overhead movement or rotation of the affected shoulder. The natural history of frozen
shoulder follows a predictable progression of symptoms, lasting from 9-24 months before
complete resolution, and results in significant loss of productivity and quality of life for
those affected [3]. Despite the significant number of patients affected by adhesive
capsulitis and the extensive literature focused on the progression and natural history of the
condition, the true underlying etiology remains poorly understood. In light of this poor
understanding of the condition, it is not surprising that a number of conservative and
invasive modalities exist as accepted treatments. These include non-steroidal
anti-inflammatory drugs (NSAIDS), oral steroids, intra-articular steroid injections, Physical
Therapy (PT), and benign neglect as well as more invasive treatments such as hydroxylation,
manipulation under anesthesia, and arthroscopic capsular release [2]. These treatments have
all be shown to have short-term benefit in pain relief, but none have proven to be superior
nor alter the long-term natural history of adhesive capsulitis.
Over the past decade, however, there has been a growing body of literature suggesting that
Propionibacterium acnes infection may play a significant role in a variety of pathological
conditions affecting the native shoulder, most notably frozen shoulder [4,5]. Our goal is to
employ a treatment strategy focused on eradicating P acnes infection as a conservative
treatment of adhesive capsulitis. Through this project, we aim to complete a prospective
randomized pilot study to examine the hypothesis that administration of intra-articular
antibiotics effective against P acnes will prove to be a superior treatment of adhesive
capsulitis as compared to current gold standard of intraarticular steroid injection.
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.
We found this trial at
1
site
Nashville, Tennessee 37212
Principal Investigator: John E Kuhn, MD
Phone: 615-322-7126
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