ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction

Completed · Not applicable

Conditions studied: Tennis Elbow

In brief

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 reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Key facts

Study ID

NCT03255733

Run by

Guided Therapy Systems

People needed

29

Starts

2015-07-14

Expected to finish

2017-03-13

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The More Foundation — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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