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ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction (ITU)

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ClinicalTrials.gov Identifier: NCT03255733
Recruitment Status : Completed
First Posted : August 21, 2017
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
More Foundation
Information provided by (Responsible Party):
Guided Therapy Systems

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 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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Device: Intense Therapeutic Ultrasound Treatment Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.
Primary Purpose: Treatment
Official Title: Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction
Actual Study Start Date : July 14, 2015
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intense Therapeutic Ultrasound Treatment
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
Other Names:
  • Guided Therapy Systems, Ardent Sound, GTS, ITU
  • Actisound




Primary Outcome Measures :
  1. Percentage of Patients Reporting at Least 25% Overall Pain Reduction [ Time Frame: 12 weeks after 1st Treatment ]
    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).


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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255733


Locations
United States, Arizona
The More Foundation
Phoenix, Arizona, United States, 85023
Sponsors and Collaborators
Guided Therapy Systems
More Foundation
Investigators
Principal Investigator: John A Kearney, MD The More Foundataion
  Study Documents (Full-Text)

Documents provided by Guided Therapy Systems:
Study Protocol  [PDF] May 4, 2015
Statistical Analysis Plan  [PDF] March 2, 2015
Informed Consent Form  [PDF] March 2, 2015


Publications:

Responsible Party: Guided Therapy Systems
ClinicalTrials.gov Identifier: NCT03255733     History of Changes
Other Study ID Numbers: GTS-ITU Epicondylosis 01
First Posted: August 21, 2017    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Guided Therapy Systems:
Chronic Lateral Epicondylitis
Tennis Elbow
Intense Therapeutic Ultrasound (ITU)
Guided Therapy Systems (GTS)
Ardent Sound, Inc.
Actisound

Additional relevant MeSH terms:
Musculoskeletal Pain
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Elbow Tendinopathy
Tendinopathy
Arm Injuries
Wounds and Injuries
Tendon Injuries