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.
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;
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.