An interventional study of Intense Therapeutic Ultrasound Treatment in Tennis Elbow, sponsored by Guided Therapy Systems. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Guided Therapy Systems · Not applicable, Interventional, and Treatment
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.
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.
297 studies on the registry are indexed under Tennis Elbow; 63 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 263 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Guided Therapy Systems is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Also known as: Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound
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).
Time frame: 12 weeks after 1st Treatment
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%)
Time frame: 12 weeks after 1st Treatment
| Milestone | Intense Therapeutic Ultrasound Treatment |
|---|---|
| Started | 29 |
| Completed | 25 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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).
| percentage of patients with less pain | Intense Therapeutic Ultrasound Treatment |
|---|---|
| Percentage of Patients Reporting at Least 25% Overall Pain Reduction | 88 |
Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)
| percentage of reported pain change | Intense Therapeutic Ultrasound Treatment |
|---|---|
| Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities | -58 (-100 to 100) |
Collected over 2 Years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intense Therapeutic Ultrasound Treatment | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Intense Therapeutic Ultrasound Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Intense Therapeutic Ultrasound Treatment |
|---|---|
| Female | 12 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | Intense Therapeutic Ultrasound Treatment |
|---|
| Region of Enrollment(Participants) | Intense Therapeutic Ultrasound Treatment |
|---|---|
| United States | 29 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2015 to primary completion in Mar 2017, 19 months.
Results were first posted in Nov 2017, 8 months after primary completion.
Of 150 interventional studies with no phase under Tennis Elbow, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's 19 months is above that.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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