Information to Patients

Scrambler Therapy success on neuropathic and oncologic pain is statistically very high, but strictly dependent on correct usage and compliance to standard protocols described in this site and primary training courses. Apart from diseases that call for more experience (phantom limb, painful anesthesia, pudendal neuralgia, trigeminal and some specifically severe forms of CRPS or CIPN) the minimum success (Pain Relief >50%) should overtake by far 80%.

Recently a multi-centric monitoring activity (in hospitals and independent university clinics) on a broad range of patients non responsive to other treatments confirmed that the correct treatment methodology and protocols allows for optimal success rates higher than 90%, and in cases of higher operator dependent variable generally higher than 80%. Whereas, where methods and standard protocols are only partially followed success percentage drops progressively in a related way. Even if in treated diseases a 50% success rate where other treatments have failed can be clinically considered as a great success it is clearly not so for patients who have not benefited from this success. Note that the monitoring outcome is in line with official scientific publications that present the same misalignment in success percentage rates clearly for the same reasons.

Recovery of presumably non responsive patients

Scrambler Therapy was created in Italy, where it is being used in public hospitals since the '90s. Primary training is carried in Italy and Prof. Marineo broadly cooperates with a excellence hospital for the recovery of specifically complex and/or apparently non responsive treatment. Most cases come from abroad. In this public structure highly qualified in ST usage specifically “difficult” cases are normally brought back to success conditions.

Since 2011, this recovery program has hosted patients from Italy and abroad who clearly presented higher than average difficulty treatment, but also cases with no specific criticality. The reasons for the unsuccessful treatment of non specifically critical cases have been analyzed. Here is a list of the common reasons that led to wrongly consider patients as non responsive.

Training

Correct training is paramount for good clinical practice of the methodology. The issues that surfaced in this sector are usually:

- Arbitrary changes of the standard protocols and training methods.

- The trained staff is not the same one who carries out the treatments or does not have an adequate knowledge of neuropathic and oncologic pain.

- Commercially, in the US “Calmare® Certified” treatment Centers are certified on the bases of quality criteria autonomously set by the former local distributor. Information gathered during the monitoring activity recorded that these criteria are relevantly not in line with the official ones and we deem they do not guarantee ST quality standards. Apart from commercial certifications, a correct treatment is only the one that follows standard protocols and methodology indicated in this website and on the official scientific documents.

- Attendance to primary training courses held in Rome is used for “commercial” reasons while according to the patients' description correct procedures are not followed, or are carried out by other operators who lack adequate training to fulfill the treatments.

- Patients are given wrong information on the therapy and the treatment's scientific and neurophysiological aspects. Assuming that this is done in good faith, it is however an indication of possible execution problems in a correct treatment cycle due to the clear lack of methodology knowledge, and more in general of clinical and neurophysiological aspects connected to chronic pain.

Treatment execution

- Often electrodes different from the ones selected as optimal with spongy contact surface have been used. In these cases distortion of information which renders the patients' perception less comfortable, can determine a less effective treatment, and in the most critical cases prevents a successful stimulation fine tuning.

- It is specifically wrong to use “large” electrodes like the ones usually used for TENS. In this case, apart from the problems previously listed, the broad electrode surface, because of its poorly selective recruitment, can stimulate wrong areas. This could lead to a pain increase during or after the treatment.

- Electrodes are reused, impairing the ability of ST to transmit information and prompting skin irritation.

- Gel is not added in order to optimize conduction.

- When the feeling of a “single sting” or “burning” occurs adequate stimulation adjustment or necessary change in placement are not carried out to eliminate these sensations, that should never be present during the treatment.

- Selection of electrode positioning is not carried out according to dermatome criteria or even worse with predetermined fixed points. A further severe mistake is that of placing the electrodes on the backbone or on the nerves assuming this will affect faraway pain areas. ST has not been designed to stimulate nerves and roots like TENS, but only poly-modal surface receptors of C fibers, therefore electrode placement must be guided only by the area of pain and patient's response. Different criteria apart from being ineffective can produce pain increase.

- Many patients spoke about operators' scientifically groundless fanciful explanations on the “single sting”. In fact it simply indicates the activation of A-delta fibres that in terms of chronaxie during the regulation phase precedes that of the C fibres. The "single sting" normally disappears when the stimulation intensity increases, or by moving the electrode (slightly outside the pain area) if the intensity increase is not enough to trigger the C fibres.

During the treatment

- A normal treatment cycle consists of 10 treatments in a two week timespan. This treatment cycle changes when:

1- The patient must be weaned off anticonvulsants for analgesic usage during the ST cycle. In this case one must consider the 10 treatments + the ones needed for the weaning.

2- The pain is zero before the end of the 10 treatments. In this case the treatment cycle must end in advance. Important note: the treatment cycle must be considered effective only when the pain during the treatment is zero or not higher than 1/10. Zero pain must include also specific movements or positions. In this case the patient must be tested in the position or movement when he or she habitually starts to feel the pain before the stimulation. One must never exceed these limits, that will spontaneously progress throughout the treatment cycle. Once zero pain has been tested under this condition, the patient must return to an analgesic position for the remaining part of the treatment. The treatment can continue beyond the statistic limits only if:

3- The previous points have been followed

4- The patient continues to show clear signs of progressive improvement.

How can I assess whether the treatment has been carried out correctly?

- Pain during stimulation is zeroed out, or is not higher that 1/10. This condition must be true also in specific positions and movements that would normally evoke pain.

- During the treatment after stimulation fine tuning the patient must be in a most comfortable (analgesic) position.

- The patient can feel different sensations, but he/she must never feel a continuos “single sting” or “burning”. In general the patient must never feel discomfort. The sole benchmark is absence of pain and no discomfort.

- A properly trained operator when using more than one channel will position them one at a time, checking the efficacy in the covered area (zero pain and no feeling of discomfort or a persistent single sting or burning). Once the positioning of the first channel has proven effective the operator with follow the same procedure in positioning other electrodes (if necessary).

- During the treatment session the patient might feel a progressive reduction in the stimulation intensity. The operator must increase the intensity to the optimal threshold perception.

- A center using STDM software is a clear sign of more care in abiding to correct standards of Scrambler Therapy usage.

- In general one can find on this website further more detailed information that allow to better understand the treatment, such as:

10 basic rules to use Scrambler Therapy correctly

Adverse interactions and protocol adjustmen t

Pseudo chronic pain and treatment expectations

Frequent errors

ST-NET usage in system-quality for clinical trials and pilot centers