Doxycycline for Elbow Tendinopathy

NCT04686799 | Completed Phase 1 FDA Drug

• 1 other identifier: 2020-1582
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis, Left Elbow; Lateral Epicondylitis, Right Elbow; Lateral Epicondylitis, Unspecified Elbow; Lateral Epicondylitis; Lateral Epicondylitis (Tennis Elbow) Bilateral; Medial Epicondylitis; Medial Epicondylitis, Right Elbow; Medial Epicondylitis, Left Elbow

Keywords

Feasibility; efficacy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Clinical outcomes - qDASH

  12 weeks

• Clinical outcomes - PRTEE

  12 weeks

• Secondarily, clinical outcomes will be measured to provide preliminary data to power a future randomized controlled trial. (Ultrasound tendinopathy grade)

  12 weeks

• Clinical outcomes - Grip strength

  12 weeks

• Clinical outcomes - MMP

  12 weeks

Study Arms (1)

SD-doxycycline group

EXPERIMENTAL

12 weeks SD-doxycycline: doxycycline hyclate 20 mg tablet by mouth twice daily

Drug: Doxycycline Hyclate 20 MG

Interventions

Doxycycline Hyclate 20 MG DRUG

Subjects will receive doxycycline 20 mg BID

SD-doxycycline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Tennis Elbow; Elbow Tendinopathy

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Brett G Toresdahl, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: December 29, 2020
• Study Start: December 3, 2020
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following study publication. No end date.
• Access Criteria: Any purpose

Locations

US (1)