ROME, ITALY, October 8, 2018 /EINPresswire.com/ --
Scrambler Therapy® Technology
The Scrambler Therapy® device is a U.S. FDA 510(k)-cleared (# K142666 for Delta International Services & Logistics) and European CE mark-certified pain therapy medical device for the noninvasive treatment of chronic neuropathic and oncologic pain.
Official Scientific and Clinical Information Site.
Scrambler Therapy® due to its immediate efficacy and absence of side effects is quickly becoming the most effective treatment for severe chronic pain also resistant to opiates, thus contributing to reduce the Opioid Epidemic.
ST is a methodology partly operator dependent and is used very differently from other treatments. Therefore the expected efficacy calls for an appropriate learning curve, and full compliance to protocols. These standards for optimal success are not always met due to lack of information and/or poor knowledge of the method.
To overcome this problem the official web site: https://www.scramblertherapy.org/english.htm provides scientific and clinical information as well as guidelines and standard protocols (registered with FDA) for the optimal usage of ST by physicians, clinical researchers, patients.
We asked Prof. Giuseppe Marineo, the researcher who invented the Scrambler Therapy® about the criticalities that still today need to be overcome for a correct methodology development:
“To date, over 1000 cases have been published in several
clinical trials, most of which were conducted by independent
researchers. This has definitely favored the acceptance of this
new method, but to insert ST in the insurance system some
Randomized controlled trials (RCT) are still needed. It is
however necessary to acknowledge that the treatment is operator
dependent. And for this reason only partial double blind or
single blind RCTs can be carried out. Attempts to do a complete
double blind automatically determines substantial changes in the
standard treatment protocol. These changes prevent the operator
to follow the normal procedures registered in the healthcare
authorizations and can erase or certainly extremely reduce the
efficacy of the treatment, consequently invalidating the
scientific data. This methodology problem is present (even more
broadly) in many other medical validated treatments such as for
example implanted stimulators. To date, from a merely scientific
point of view, to avoid the introduction of Bias which makes the
clinical outcomes unreliable the available solutions are:
- RCT vs sham / TENS partially double blind (ST operator
cannot be blind)
- RCT vs validated protocol therapies
- Double Blind with single arm sham to analitically determine the placebo effect. The following treatment of the same patients with the normal procedure will guarantee the trial’s ethicality, and provide further comparable results. Data from this type of study, the only possible one for a complete double blind, could later be used in other clinical trials as a virtual control arm allowing to extract from the successful results the statistical bias of the placebo effect"
For further information on research protocols read section “Clinical Research”:https://www.scramblertherapy.org/clinical-research.htm
About Delta International Service & Logistics (DIS&L)
DIS&L is an agency created for the international development of Scrambler Therapy® Technology (international patent), and selecting of medical device distributors in all international area. DIS&L through its law firm is the only company authorized to sign international exclusive agreements, provide maintenance and distributor support for method usage training and other logistics needs.
More info: https://www.st-team.eu
Contact U.S. DIS&L Division:
Richard J. Erickson, North America Operations 6419 Hirondel St, Houston, TX 77087,406-249-0424 firstname.lastname@example.org More info: https://www.st-team.eu/scrambler-therapy-in-u.s..htm
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