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Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * Individuals 18-70 years of age * Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities. * Failed alternative treatment for \> 3 months. Exclusion Criteria: * Surgical procedure on affected extremity within last six months. * Dermatological disorder in affected area * Currently pregnant, confirmed via pregnancy test. * Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders. * Failed prior surgical procedure on the affected joint. * No prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).
About the study
Lateral epicondylitis (Tennis Elbow) can cause pain and keep individuals from completing their daily activities and require them to miss work. There are currently different treatment options to address tennis elbow. However surgeons do not know if one is better than the other. This study will compare two treatment options for tennis elbow. Participants will either be treated by Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. Traditional open surgical debridement is a surgical procedure that requires the surgeon to make an incision to remove the damaged tissue. This procedure is done under anesthesia in a surgery center. In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.
What is being tested
- Tenex Procedure (procedure)
- Open Debridement Surgical Intervention Treatment Plan (procedure)
Sponsor: Sean Mc Millan · Participants: 90 · Started: Feb 9, 2023
Contact the study team
- Donna Hoopes · Phone: 856-355-1206
Official record on ClinicalTrials.gov — NCT05757739
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.