ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction (ITU)
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| ClinicalTrials.gov Identifier: NCT03255733 |
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Recruitment Status :
Completed
First Posted : August 21, 2017
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tennis Elbow | Device: Intense Therapeutic Ultrasound Treatment | Not Applicable |
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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Intense Therapeutic Ultrasound Treatment
Other Names:
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- 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).
- 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 |
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.
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
| United States, Arizona | |
| The More Foundation | |
| Phoenix, Arizona, United States, 85023 | |
| Principal Investigator: | John A Kearney, MD | The More Foundataion |
Documents provided by Guided Therapy Systems:
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:
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Chronic Lateral Epicondylitis Tennis Elbow Intense Therapeutic Ultrasound (ITU) |
Guided Therapy Systems (GTS) Ardent Sound, Inc. Actisound |
Additional relevant MeSH terms:
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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 |