Evaluating the Feasibility of Subantimicrobial-dose Doxycycline for Elbow Tendinopathy

2020-1582

To evaluate the feasibility of subantimicrobial -dose (SD) doxycycline to improve outcomes of nonsurgical management of elbow tendinopathy via matrix metalloproteinase (MMP) inhibition as well as evaluate if participants will be compliant to with prescribed medication and exercise treatment. Our working hypothesis is that patients with elbow tendinopathy will be receptive to treatment with SD-doxycycline and compliant with the prescribed treatment.

2020-12-03

2024-11-01

2024-11-01

Active (not recruiting)

Early phase I

25

Inclusion Criteria: * Males and females ages of 18 and up * Atraumatic unilateral elbow pain of ≥ 6 weeks duration * Diagnosed clinically as lateral or medial elbow tendinopathy * Activity-related lateral or medial elbow pain * Tenderness of the lateral or medial epicondyle * Pain with gripping and/or resisted wrist extension with the elbow extended * Pain with passive wrist flexion and finger with the elbow extended * Internet access to complete electronic surveys Exclusion Criteria: * Prior surgery of the affected elbow * Prior injection of the affected lateral or medial epicondyle or extensor tendons * Prior extracorporeal shockwave therapy to the affected elbow * Suspicion for radial tunnel syndrome (tenderness distal to the lateral epicondyle in the area of the supinator muscle dorsally, pain with resisted supination with the elbow extended, and/or weakness of the extensor digitorum communis) * Separate upper extremity injury or condition that would interfere with full participation in the home exercise program * Fluoroquinolone-associated tendinopathy * Ligamentous laxity on exam * Evidence of osteoarthritis or osteochondral lesion on radiographs * Autoimmune condition * Pregnant, intend to become pregnant, or breastfeeding * Premenopausal women who are not using contraception * Allergy to doxycycline or other tetracyclines * Current esophagitis or peptic ulcer disease * Current use of medication for which there is a drug interaction with doxycycline * Who do not speak English

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The plan for achieving the specific aims is to first assess patient receptiveness by screening patients with symptomatic lateral or medial elbow tendinopathy for eligibility and tracking the proportion of eligible patients who decline participation in the study due to not wanting to take an extended course of SD-doxycycline. 25 subjects will given SD-doxycycline and have the tendinopathy grade measured by ultrasound. The medication will be prescribed for 12 weeks during which time logs will be used to track compliance and monitor side effects. This will be done in combination with usual care, which includes a home exercise program, a counterforce brace, and over-the-counter pain medication to use as needed. Clinical effectiveness outcomes will include patient reported outcomes, ultrasound tendinopathy grade, grip strength, and markers of MMP activity and collagen production/connective tissue anabolism.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

2023-12-13