Status:
COMPLETED
ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction
Lead Sponsor:
Guided Therapy Systems
Collaborating Sponsors:
More Foundation
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain red...
Detailed Description
Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coa...
Eligibility Criteria
Inclusion
- Chronic Pain (\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Unilateral Pain
- Willingness to complete treatment and post treatment regimen as described.
- Patients who have provided written and verbal informed consent.
Exclusion
- Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Key Trial Info
Start Date :
July 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03255733
Start Date
July 14 2015
End Date
March 13 2017
Last Update
November 17 2017
Active Locations (1)
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1
The More Foundation
Phoenix, Arizona, United States, 85023