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Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis (DOXY)

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ClinicalTrials.gov Identifier: NCT03479502
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
Nicholas Dantzker, Vanderbilt University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Adhesive Capsulitis of Unspecified Shoulder Frozen Shoulder Drug: Methylprednisolone Injectable Product Drug: Doxycycline Injection Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Primary Purpose: Treatment
Official Title: Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Active Comparator: Methylprednisolone
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) with 20 patients in each group. Injections will be administered by the treating physician.
Drug: Methylprednisolone Injectable Product
3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks
Other Name: Prednisone

Active Comparator: Doxycycline
Patients meeting the inclusion criteria will be randomized 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.
Drug: Doxycycline Injection
3 intra-articular injections of Doxycycline Injection spaced every two weeks
Other Name: Doxy




Primary Outcome Measures :
  1. Change in American Shoulder and Elbow Score (ASES) [ Time Frame: Baseline and 12 months ]
    The ASES questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies

  2. Change in Range of motion(ROM) measurements [ Time Frame: Baseline and 12 months ]
    The ROM measurements will include forward flexion, abduction, external rotation at the side and at 90 degrees abduction, and internal rotation at the side and at 90 degrees abduction recorded by the treating physician at follow up visits


Secondary Outcome Measures :
  1. number of medical co-morbidities [ Time Frame: Baseline ]
    number of medical co-morbidities per participant

  2. Duration of symptoms [ Time Frame: Baseline ]
    Length of time participants have experienced shoulder symptoms

  3. Changes in Pain [ Time Frame: Baseline ]
    Number of participants with current dominant symptom and/or dominant symptom with disease onset

  4. Pain with sitting [ Time Frame: Baseline ]
    Number of patients that have pain while sitting or have ever had pain while sitting will be recorded using patient-reported survey and review of the patient's electronic medical record in Epic.

  5. Stiffness [ Time Frame: Baseline ]
    Number of participants with current dominant symptom and/or dominant symptom with disease onset



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479502


Contacts
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Contact: Rosemary A Sanders, BA 615-322-7126 rosemary.a.sanders@vanderbilt.edu
Contact: Nicholas J Dantzker, MD nicholas.j.dantzker@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Rosemary A Sanders, BA    615-322-7126    rosemary.a.sanders@vanderbilt.edu   
Principal Investigator: John E Kuhn, MD         
Sub-Investigator: Nicholas J Dantzker, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Orthopedic Research and Education Foundation
Investigators
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Study Director: John E Kuhn, MD Study Director

Publications of Results:

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Responsible Party: Nicholas Dantzker, Resident, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03479502     History of Changes
Other Study ID Numbers: 172011
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Doxycycline
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents