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Is the outcome of the clinical trial “A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN)“ reliable?

The main issue that still today prevents carrying out Scrambler Therapy clinical trials without methodology mistakes and bias is linked to three main variables, easily identified in:

- Non-optimized formation levels in the device usage.

- Incomplete compliance and/or changes to the official standard protocol treatment.

- Failure to use the STDM support software and ST-NET network. ( http://www.scramblertherapy.org/st-net-project.htm )

The negative effects of these variables have a meaningful impact on the reliability of the clinical trials that can be easily offset by following the official standards.

The statistical data  of the clinical trial mentioned above, however, present another different (an unique) issue from the ones recorded in the past. During the daily treatment the pain doesn’t seem to have been zeroed out in none of the patients, which is an essential requirement  for the effective therapy outcome included in all standard protocols and any other official document. This can occur only when the operator has no knowledge on the methodology and no ability in the correct device usage.

Ruling out this assumption, there seems to have been an involuntary mistake in the protocol  treatment. This can occur in double blind trials due to the rules that prevent communication between the clinical trial team.

In this case (the only one that seems realistically possible), the original problem can probably be traced back to the sham used in the clinical trial, where from the very beginning a series of intrinsic issues have been identified. This topic is better explained on:  http://www.scramblertherapy.org/active-sham.htm .

In order to overcome this problem Dr. Toby Campbell was given a protocol that allows to use Calmare MC-5A itself as an active sham. This protocol (approved by IRB of Pediatric Hospital "Bambino Gesù" ) can make the therapy ineffective even if the patient is under the impression of undergoing the normal treatment, since it is using a perfectly functioning Calmare MC-5A device. By so doing, even if the patient might have prior knowledge of the device the placebo effect remains valid, since there are no differences in form or functioning identifiable by the patient.

The outcome of the patients treated with MC-5A in  the  above mentioned clinical trial is not in line with the previous scientific literature and normal clinical practice, but rather correspond perfectly to the provided MC-5A sham protocol usage. Therefore, we have reached the reasonable conclusion that this sham procedure was mistakenly used a normal therapeutical treatment. After all in his role as double blind clinical trial investigator, Dr. Toby Campbell could not verify possible implementation or protocol mistakes, and this seems to have been the case. 

Acknowledging the clinical trial team’s good faith, the fact still remains that data that correspond to an incorrect usage of the device have been published at the internationally renowned ASCO Conference.

Today we respectfully ask Dr. Toby Campbell and the IRB of University of Wisconsin Carbone Cancer Center to act in order to avoid clinical trials with the same clear issues. This is easily achievable by following the standard official procedure that guarantee reliable clinical trial, that can be summarized as follow:

 

1) Employ operators adequately trained in the methodology who can zero out the pain during the daily treatment in at least 80% of the patients, the minimum average to produce clinical trials without excessive bias. 

2) Use only official treatment protocols, and support and monitoring provided free of charge to researchers involved in clinical trials. This enables to respect the study’s independence without impairing the quality and reliability of the outcomes. One must keep in mind that Scrambler Therapy is a new therapy. Any other previous electro-analgesia experience  cannot  be used, because radically different and incompatible with Scrambler Therapy. 

3) Use STDM, a free of charge support software and network specifically devised to drastically reduce the operator-dependant variable in clinical trials and normal hospital practice. These support tools immediately inform the operator in cases of treatment  anomalies, providing adequate solutions.

These simple rules make up the current Gold Standard of ST that enable to carry out easily reproducible clinical trials, with homogeneous outcomes. They provide more effective results on the patients, both in quantity and quality, and immediately detect involuntary errors that produce unreliable outcomes.

Provided that Dr. Toby Campbell and the IRB of  University of Wisconsin Carbone Cancer Center will adopt this official Gold standard, we are confident that the next published outcomes will be in line with the current  outcome reference standard.

In the meantime, I thank Dr. Toby Campbell for his efforts in this therapy’s  clinical trials.

 

Basic scientific literature  (only indipendent ) of reference

1: Smith TJ, Coyne PJ, Parker GL, Dodson P, Ramakrishnan V. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. J Pain Symptom Manage. 2010 Dec;40(6):883-91. doi: 10.1016/j.jpainsymman.2010.03.022. PubMed PMID: 20813492.

3: Ricci M, Pirotti S, Scarpi E, Burgio M, Maltoni M, Sansoni E, Amadori D. Managing chronic pain: results from an open-label study using MC5-A Calmare®device. Support Care Cancer. 2012 Feb;20(2):405-12. doi:10.1007/s00520-011-1128-6. Epub 2011 Mar 11. Erratum in: Support Care Cancer.2013 Mar;21(3):913. PubMed PMID: 21394458.

4: Ko YK, Lee HY, Lee WY. Clinical experiences on the effect of scrambler therapy for patients with postherpetic neuralgia. Korean J Pain. 2013 Jan;26(1):98-101.doi: 10.3344/kjp.2013.26.1.98. Epub 2013 Jan 4. PubMed PMID: 23342218; PubMed Central PMCID: PMC3546221.

5: Park HS, Sin WK, Kim HY, Moon JY, Park SY, Kim YC, Lee SC. Scrambler therapy for patients with cancer pain - case series -. Korean J Pain. 2013 Jan;26(1):65-71. doi: 10.3344/kjp.2013.26.1.65. Epub 2013 Jan 4. PubMed PMID: 23342211; PubMed Central PMCID: PMC3546214.

6: Ghatak RK, Nandi SN, Bhakta A, Mandal GC, Bandyopadhyay M, Kumar S. Prospective study of application of biological communication (cybernatics) in management of chronic low back pain--a preliminary report. Nepal Med Coll J. 2011 Dec;13(4):257-60. PubMed PMID: 23016475.

ASCO annual meeting 2012 http://www.competitivetech.net/news/120518.html

Preliminary data Multicenter clinical trial about 200 patients. Clinical Success rate 80-90%  ( http://www.fondazioneisal.it/pubblicazioni/weblog/143-scrambler-therapy-una-nuova-arma-contro-il-dolore).

Pain Center involved:
- University Hospital Careggi,  Florence - Italy
- University Hospital of Parma - Italy
- Hospital Colli Monaldi - Cotugno - CTO - NAPLES - Italy
- Hospital “ MARIANO SANTO”- Cosenza - Italy
- CTO Hospital - Rome - Italy

Conflict of interest