Frequently asked questions (FAQ)
Is Scrambler Therapy just a Standard TENS?
As far as the FDA classification of ST as a TENS device, simply means that ST is a device that uses surface electrodes (Note 1). In fact, the FDA after “TENS" authorization added “Scrambler Therapy”, for a complete, correct and specific functional identification of the device.
It is furthermore easy to demonstrate that with the exception of the Scrambler Therapy, all electro-analgesia devices authorized by the FDA, and especially standard TENS or its variants, are based on the Gate Control theory and for this reason are specifically designed to stimulate myelinized fibers and avoid the stimulation of C fibers, in line with conventional electro-analgesia general standards. Whereas Scrambler Therapy is based on its own standalone theory model in contrast with the Gate Control theory, and specifically uses C fibers.
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES
Sec. 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient’s skin to treat pain
(b) Classification. Class II (performance standards).
What are the steps to follow to overcome Scrambler Therapy operator-dependent feature?
Why does the FDA clearance include two TENS as predicate device?
FDA has various ways for the approval and clearance of medical devices. The distributor normally tends to choose the short procedure, also known as 510(k) "Substantial Equivalence “. This procedure calls for indication of one or more medical devices of the same reference category (in this case electro- analgesia). FDA assesses the degree of similarity between reference devices and the new one. If the device undergoing FDA clearance has substantially the same technology and clinical (efficacy and safety) features like the indicated reference device (normally a standard TENS) the clearance process is rapidly achieved and no specific clinical trials are requested.
If the device technology and clinical features are different from the ones of reference predicate device, FDA calls for specific clinical trials that must demonstrate that the new device has equal or higher efficacy and safety features than the ones already authorized. This was the procedure followed to market ST in the US. This is the reason why the FDA in the clearance lists the referenced predicate devices. In this case, however the FDA does not mean to say that the predicate devices have the same technology and clinical features of ST (in fact, FDA requested specific clinical trials) but simply that ST according to clinical trials forwarded has efficacy and safety features equal or higher than authorized reference devices.
Is ST-NET compliant to Health Insurance Portability And Accountability Act (HIPPA)?
Yes, ST-NET is fully compliant to HIPAA privacy standards. Implemented multi-level protection requirements are higher than those in most popular commercial software.
How Scrambler Therapy changes pain therapy
ST has been studies and tested successfully in types of chronic pain that were previously considered untreatable, or poorly responsive to strong drugs mix. At the current state of our knowledge, the treatment apart from not producing undesired effects, it is also more economically convenient compared to other solutions and produces better results in patients. ST has also modified chronic pain theory models, since it is the first pain device to use a model capable of going beyond the more than 50 year old Gate Control Theory, previous scientific reference standard for other therapies.
Is it invasive, are there side-effects?
It is a non-invasive methodology, that at the current state of knowledge used correctly does not have side-effects or undesired effects. It is very simple and uses disposable surface electrodes.
What are the expectations?
There are various protocols according to different types of pain treated. In chronic benign pain caused by cures, such as for example CIPN, a treatment cycle is enough for a long period of wellbeing. In oncologic pain due to the presence of metastasis, after the initial treatment cycle further treatments should be carried out whenever pain re-emerges.
What are the success possibilities?
In general, if a specifically trained operator carries out the treatment, chances of success are very high. In the worst case around 60%, however they can be higher than 90%. The physician can make a more detailed forecast after a consultation.
How will I know if this treatment works for me?
It is very simple. During the first treatment, after the electrodes correct positioning and fine-tuned stimulation levels, you will immediately be pain-free and have no discomfort. In the subsequent treatments you will realize that pain will re-emerge with less intensity, and the duration of pain relief is prolonged.
How long does the treatment last?
The treatment normally lasts for 30 minutes plus the time necessary to position and regulate electrode stimulation: a treatment a day, Monday thru Friday, for two weeks in a row. Specific cases can require different number of treatments.
Can it work with acute pain?
Yes, but in this case it works simply as a symptomatic therapy. This means that it must be used every time pain occurs, until the normal healing process solves the cause that generated it.
What do you feel during stimulation?
During stimulation intensity regulation you can feel something like a “single sting”. When the stimulation level regulation is concluded (rather quickly), the single sting feeling is replaced by feelings that vary and are often described as pleasant. When the fine-tuning has been completed you will not feel pain in the treated area.
How is the device used?
Scrambler Therapy is a stand -alone medical electroanalgesia device, and does not require combinations with other analgesic therapies.
Why the name Scrambler Therapy?
Scrambler techniques were first used for military reasons. A Scrambler is a device capable of transforming a piece of original information into another type of information, no longer recognizable. Since the scientific research that led to this technology is based on the active principle of replacing information of pain into “non-pain”, the inventor thought the name “Scrambler Therapy” was the most appropriate one.