Clinical Researcher Area

Scrambler Therapy is a methodology already authorized for ambulatory care and hospital treatment practically worldwide, and can therefore no longer be considered an experimental treatment. However, Scrambler Therapy poses a radical change in fundamental pain medicine canons, and not only in clinical practice. Especially the theory reference model developed to produce this therapy, rewrites what was previously known and accepted by the scientific community on chronic pain, and models such as the Gate Control theory. This consequently led to the need for a thorough discussion with necessary experimental validation of international studies carried out by independent researchers.

By carrying out clinical trials, you are taking a further step towards this shared knowledge path.  To design a correct investigation protocol you will need a lot of information. In this website you will find the most important information and through the contact link you can ask for further information or necessary support.

Basically there are some mandatory preparatory conditions in carrying out a clinical trial on Scrambler Therapy. Unbiased clinical trials based on correct methodology call for:

- An official training course (preferably primary) on the correct methodology usage.
- Study protocols compliant to Scrambler Therapy guidelines, considered critical and fundamental parts of correct study execution.
- If possible usage of ST-NET,  the telematics support network, that is also part of  normal clinical practice.

What type of trials?

On the date this page is being filled, different clinical trials have been published on different types of severe chronic and oncologic pain resistant to all other treatment for a total of about 1000 cases. No study has shown risks on the patient or adverse and side effects.

Considering it is an operator dependent methodology that calls for an adequate learning curve, the first independent trials show worse outcome compared to the reference trials. In time, with progress in the methodology knowledge, better training, clinical trials carried out only after having completed the learning curve, and more compliance to standard usage protocols, these differences have progressively decreased or disappeared.

As of today from a merely scientific view point to avoid the introduction of added Bias that would make the trials unreliable the solutions could be:

- RCTs vs sham/TENS partially double blind (ST operator cannot be blind)

- RCTs vs protocol therapies

- Double Blind with single arm sham using the same ST device intentionally in the wrong way to analytically determine the placebo effect. Data of this type of study can then be used for other comparative bio-statistic trials as analytical reference. 

General inclusion and exclusion criteria
Trials should mainly be centered on patients non-responsive to other methods, with truly high intensity and persistent chronic pain (see: Pseudo-chronic pain and treatment expectations).

The main inclusion criteria (example) are:
Patients 18 years and older;
Neuropathy pain (DETECT pain score higher than 18);
NRS > 7 at least once in the last 24 hour;
Having tried at least 3 monotherapy drugs or combination without effective response;

The main exclusion criteria (example) are:
Patients with pacemaker, automatic defibrillator or metallic valves, spinal cord stimulators, metallic/ conductive components.
Patients with aneurism clip or vena cava;
Neuro lesions for pain control;
Pregnancy;
Epilepsy;
Headaches or similar variants.
Pain originating from central nervous system, or oncologic pain if cancer areas are  still present (requires a different specific application protocol, ask for information at contact link.)
Previous or still underway treatments with Ketamine, or Ketamine usage as narcotic drug.
Treatment underway with muscle-relaxants.
Treatments underway capable of generating neuropahy.
Treatments that can modify biochemistry analysis or fMRI if used in the protocol.
Other limitations that prevent a correct standard treatment (typically no pain-free area to position the electrodes).

Treatment protocol in chronic benign pain
The treatment requires a cycle (that can be repeated) of at least 10 treatments;  5 days a week starting from Monday (two weeks in a row).  Each treatment lasts for approximately  45 minutes.
Discontinue intake of anticonvulsant drugs for analgesic purposes at least two weeks before starting the treatment. In case of documented efficacy or patient refusal, weaning off anticonvulsant drugs must be carried out during the treatment in line with treatment benefit progression. In this case the number of necessary treatments will be 10 plus the ones necessary for weaning following the same frequency as in  a normal cycle.

Self-assessment in the ability to correctly use the Scrambler Therapy

Key to the pain system remodulation process achieved by Scrambler Therapy is the ability to zero out pain during each treatment session, without the patient feeling any discomfort due to stimulation. In the standard treatments envisaged in inclusion/exclusion criteria mentioned above, and other specific indication on the Home Page at “Rapid support for research and best clinical practice”, this is always possible. Therefore one can easily and automatically assess the ability to correctly use the methodology based on being able to zero out pain during the treatment session.

Other considerations
Assistance support guarantees reproducible results and is consistent with studies based on EBM,   aimed at eliminating or reducing, within allowed limits, each disturbance variable that could alter results of clinical trials.