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Frequently asked questions

Can I use the Scrambler Therapy if I have an implanted stimulation device?

Absolutely no, and more specifically if you have a cardiac pacemaker. The same ban is true for spinal cord stimulators, even in the case the stimulator is switched off. These provisions are part of the safety rules applied by all international health authorities, especially the European ones and the FDA.

Is Scrambler Therapy just a Standard TENS?

Scrambler Therapy basic functioning is completely opposite to that of a TENS device or any other form of electro-analgesia historically known. This is one of the reasons why the application fields are radically different, as well as its results. For more info please read: https://journals.sagepub.com/doi/10.1177/1534735419845143

What are the steps to follow to overcome Scrambler Therapy operator-dependent feature?

- Training Course.

- ST-Net Project.

Why does the old FDA clearance (#K081255) 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 as 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 the reference predicate device, the 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 the FDA in the first clearance, references predicate devices. In this case, however, the FDA does not mean to imply that the predicate devices have the same technology and clinical features as ST (in fact, the FDA requested specific clinical trials) but simply that ST, according to clinical trials forwarded, has efficacy and safety features equal to or higher than authorized reference devices.

With the new 510(k) issued December 23, 2020, only for the Scrambler Therapy® Technology ST-5A new device, eliminating the predicate devices, this problem has been resolved.

Is ST-NET compliant with the Health Insurance Portability and Accountability Act (HIPPA) and General Data Protection Regulation (GDPR)?

Yes, ST-NET is fully compliant with HIPAA and GDPR 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 studied and tested successfully in types of chronic pain that were previously considered untreatable or poorly responsive to strong drug mixes. At the current state of our knowledge, the treatment, apart from not producing undesired effects, 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, the 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, for example, caused by cures, such as CIPN, a treatment cycle is enough for a long period of well-being. In oncologic pain due to the presence of metastasis, after the initial treatment cycle, further treatments should be carried out whenever pain re-emerges.

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 through Friday, for two weeks in a row. Specific cases can require different numbers 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 electro-analgesia 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 with “non-pain,” the inventor thought the name “Scrambler Therapy” was the most appropriate one.

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