IRB Number: 2020-1582
May 20, 2021
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Principal Investigator
Brett G. Toresdahl, MD
Co-Investigators
Scott A. Rodeo, MD
Joshua S. Dines, MD
Harry G. Greditzer IV, MD
John P. DiFiori, MD, FACSM
Andy 0. Miller, MD
Daphne I. Ling, Ph.D
Miguel Otero, Ph.D
Summary
Enrolling 25 participants. Once someone is enrolled in the study, blood will be drawn at baseline and 12 weeks as well as an ultrasound of the affected arm (at HSS main campus). They will also be asked to take a 12-week course of subantimicrobial-dose doxycycline as well as be given a home exercise program to complete weekly. At the end of the study, participants will get paid $75 per visit (up to $150 for the entire study).
Inclusion/Exclusion Criteria
Inclusion:
- Males and females ages of ≥ 18-60
- 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/forearm supination
- Pain with passive wrist flexion
- Internet access to complete electronic surveys
Exclusion:
- 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 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 except for those in a same-sex relationship or who are sexually inactive
- 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, including anticoagulants, penicillins, and methoxyflurane
- Who do not speak English or are unable to complete surveys in English
Contact Information
Brianna Quijano
quijanob@hss.edu
646.797.8458