Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orthopedic Devices Associated With Misadventures
- Sponsor
- Virtua Health, Inc.
- Enrollment
- 90
- Locations
- 5
- Primary Endpoint
- Background: Ultrasound-guided Percutaneous Tenotomy Technique
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
During the initial screening visit, the physician will obtain your medical history and perform a physical exam. If you pass the screening, you will be randomized into either Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. It will be a 50% chance. It will be compared to flipping a coin. Once you have been placed in your treatment group, your treatment will be scheduled. You will then undergo your procedure and provided referral for physical therapy. You will also have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 5 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. You will also be requested to complete two patient questionnaires about your progress at visits 3-7.
Investigators
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).
Outcomes
Primary Outcomes
Background: Ultrasound-guided Percutaneous Tenotomy Technique
Time Frame: 3 months
Background: Ultrasound-guided Percutaneous Tenotomy Technique