ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction

Study Overview
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Brief Summary
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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.

Detailed Description
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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 coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction. ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide have been treated using this technology. Clinical studies have shown that 85% of patients receiving this treatment on facial skin tissue showed an improvement in facial lifting with no significant pain, erythema, inflammation or scarring by creating the same coagulative changes to the connective tissue under the skin. Histologically, it has been shown that ITU induces the production of dermal collagen with thickening of the dermis and straightening of the elastic fibers in the reticular dermis. On-going research in laboratory studies has shown that ITU can improve healing of damaged Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta 1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated with ITU compared to injured, untreated rabbit tendons.

Official Title
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Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction

Conditions
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Tennis Elbow

Intervention / Treatment
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* Device: Intense Therapeutic Ultrasound Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intense Therapeutic Ultrasound Treatment<br>Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart. | Device: Intense Therapeutic Ultrasound Treatment<br> <br> * Other names: Actisound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Reporting at Least 25% Overall Pain Reduction | Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10). | 12 weeks after 1st Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities | Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%) | 12 weeks after 1st Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lateral Epicondylitis, Tennis Elbow, Intense Therapeutic Ultrasound (ITU), Guided Therapy Systems (GTS), Ardent Sound, Inc., Actisound