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Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis

NCT03479502 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-01-18

Study results available
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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.

Conditions

  • Adhesive Capsulitis
  • Adhesive Capsulitis of Unspecified Shoulder
  • Frozen Shoulder

Interventions

DRUG

Methylprednisolone Injectable Product

3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks

DRUG

Doxycycline Injection

3 intra-articular injections of Doxycycline Injection spaced every two weeks

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • John E Kuhn, MD · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2022-02-08
Completion
2022-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479502 on ClinicalTrials.gov