Lateral Epicondylitis Clinical Trial
Official title:
Evaluating the Feasibility of Subantimicrobial-dose Doxycycline for Elbow Tendinopathy
Verified date | December 2023 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primarily a feasibility study of SD-doxycycline as an adjunctive treatment for elbow tendinopathy (Compliance) | Compliance: At the end of the study, compliance will be calculated using the number of self-reported doses taken divided by the number of prescribed doses (twice daily x 7 days per week x 12 weeks = 168 doses). | 12 weeks | |
Primary | Receptiveness | The number of patients who enroll in study divided by the number eligible patients minus the number of patients who decline due to reasons unrelated to the prescribed treatment, e.g., unable to return for second study visit. This will be measured at time of study recruitment. | 12 weeks | |
Secondary | Clinical outcomes - qDASH | quick Disabilities of the Arm Shoulder and Hand score (by qDASH score) at baseline, 4, 8, and 12 weeks | 12 weeks | |
Secondary | Clinical outcomes - PRTEE | Patient-Rated Tennis Elbow Evaluation (by PRTEE test ) at baseline, 4, 8, and 12 weeks | 12 weeks | |
Secondary | Secondarily, clinical outcomes will be measured to provide preliminary data to power a future randomized controlled trial. (Ultrasound tendinopathy grade) | Ultrasound tendinopathy grade at baseline at 12 weeks - by ultrasound | 12 weeks | |
Secondary | Clinical outcomes - Grip strength | Grip strength at baseline and 12 weeks - measure by hand-held dynamometer | 12 weeks | |
Secondary | Clinical outcomes - MMP | Matrix metalloproteinase (MMP) inhibition activity and collagen production/connective tissue anabolism at baseline and 12 weeks - measure by blood test | 12 weeks |
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