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Managing chronic pain: results from an open-label study using MC5-A Calmare® device

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Supportive Care in Cancer Aims and scope Submit manuscript

An Erratum to this article was published on 30 December 2012

Abstract

Background

Despite state-of-the-art therapeutic strategies for pain, some types of chronic pain remain difficult to treat. We evaluated the effectiveness of an innovative neuromodulative approach to the treatment of chronic pain using electrical stimulus integrated with pharmacological support.

Methods

The MC5-A Calmare© is a new device for patient-specific cutaneous electrostimulation which, by “scrambling” pain information with “no pain” information, aims to reduce the perception of pain intensity. We prospectively treated 73 patients with cancer- (40) and non-cancer-related (33) pain whose pain management was unsatisfactory. The primary objective of the study was to assess efficacy and tolerability of the device. Pain intensity was assessed daily with a Numerical Rating Scale (NRS) for the duration of treatment (2 weeks) and then on a weekly basis for the 2 weeks of follow-up.

Results

Mean pain value at T0 (pre-treatment value) was 6.2 [±2.5 SD (standard deviation)], 1.6 (±2.0) (p < 0.0001) at T2 (after the 10th day of treatment), and 2.9 (±2.6) (p < 0.0001) at T4 (after the second week of follow-up, i.e., 1 month after the beginning of treatment). Response after the second week of treatment showed a clear reduction in pain for both cancer (mean absolute delta of the reduction in NRS value = 4.0) and non-cancer (mean delta = 5.2) patients. The pain score had decreased by 74% at T2. On the basis of pre-established response criteria, there were 78% of responders at T2 and 81% at T4. No side effects were reported.

Conclusions

Our preliminary results suggest that cutaneous electrostimulation with the MC5-A Calmare© can be hypothesized as part of a multimodality approach to the treatment of chronic pain. Further studies on larger numbers of patients are needed to assess its efficacy, to quantify the effects of inter-operator variability, and to compare results obtained from the active device versus those from a sham machine.

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Acknowledgment

The authors wish to thank Gráinne Tierney for editing the manuscript.

Conflict of interest

There are no conflicts of interest to declare.

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Authors and Affiliations

  1. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Via P. Maroncelli 40, 47014, Meldola, FC, Italy

    Marianna Ricci, Emanuela Scarpi, Marco Burgio & Dino Amadori

  2. Palliative Care Unit, Forlimpopoli Hospital, Via Duca d’Aosta 33, 47034, Forlimpopoli, FC, Italy

    Sara Pirotti, Marco Maltoni & Elisabetta Sansoni

Authors
  1. Marianna Ricci
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  2. Sara Pirotti
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  3. Emanuela Scarpi
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  4. Marco Burgio
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  5. Marco Maltoni
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  6. Elisabetta Sansoni
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  7. Dino Amadori
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Corresponding author

Correspondence to Marco Maltoni.

Additional information

This study was partially funded by Legacoop Provincia Forlì-Cesena.

An erratum to this article can be found online at http://dx.doi.org/10.1007/s00520-012-1695-1.

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Ricci, M., Pirotti, S., Scarpi, E. et al. Managing chronic pain: results from an open-label study using MC5-A Calmare® device. Support Care Cancer 20, 405–412 (2012). https://doi.org/10.1007/s00520-011-1128-6

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  • DOI: https://doi.org/10.1007/s00520-011-1128-6

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