Managing chronic pain: results from an open-label study using MC5-A Calmare® device
Marianna Ricci1, Sara Pirotti, Emanuela Scarpi
1Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via P Maroncelli 40, 47014 Meldola, FC, Italy.
Summary
This study shows that the MC5-A Calmare device effectively reduces chronic pain perception through cutaneous electrostimulation. The innovative neuromodulative approach offers a promising, well-tolerated treatment for both cancer and non-cancer pain patients.
Area of Science:
- Neurology
- Pain Management
- Biomedical Engineering
Background:
- Chronic pain remains a significant challenge despite advanced treatments.
- Neuromodulation offers a novel therapeutic avenue for refractory pain conditions.
- Electrical stimulation integrated with pharmacological support is being explored for pain relief.
Purpose of the Study:
- To evaluate the efficacy and tolerability of the MC5-A Calmare device for chronic pain.
- To assess the impact of patient-specific cutaneous electrostimulation on pain intensity.
- To investigate this approach in patients with both cancer and non-cancer-related pain.
Main Methods:
- Prospective treatment of 73 patients with unsatisfactory pain management.
- Utilized the MC5-A Calmare device for patient-specific cutaneous electrostimulation.
- Assessed pain intensity using the Numerical Rating Scale (NRS) during treatment and follow-up.
Main Results:
- Significant reduction in mean pain scores from 6.2 at baseline to 1.6 after treatment (p < 0.0001).
- Achieved a 74% decrease in pain score by the end of the second week of treatment.
- Reported high responder rates (78% at T2, 81% at T4) with no reported side effects.
Conclusions:
- Preliminary findings suggest MC5-A Calmare electrostimulation is a viable component of chronic pain management.
- The device demonstrated significant pain reduction and tolerability in the studied population.
- Further research with larger cohorts is recommended to validate efficacy and compare against sham treatments.

