Ricci, M., Pirotti, S., Scarpi, E., Burgio, M., Maltoni, M., Sansoni, E., & Amadori, D. (2012). Managing chronic pain: Results from an open-label study using MC5-A Calmare® device. Supportive Care in Cancer, 20, 405–412.

To assess the efficacy and acceptability of the MC5-A Calmare® device

The Calmare device produces electrical nerve stimulation that is transmitted to nociceptors in order to modulate the pain response. Electrodes were placed on the skin according to the area of pain to be treated. Patients could receive up to a maximum of four treatments per day. Ten 30-minute sessions of the stimulation therapy for two consecutive weeks were delivered Monday through Friday. Pre- and post-treatment assessments were done after the first week and after the tenth day of treatment. Patients continued their usual regimen of analgesics.

• The study reported on a sample of 73 patients.
• Median patient age was 66 years, with a range of 28–87 years.
• The sample was 52% male and 48% female.
• The sample included patient with cancer and noncancer patients as well.
• Of the patients with cancer, 56% had nociceptive pain and 34% had neuropathic pain; most had pain duration greater than three months; and 58% were on strong opioids.

• Single site
• Inpatient and outpatient settings

Patients were undergoing long-term follow-up care.

The study has clinical applicability for end-of-life and palliative care; and elderly care.

A prospective, exploratory, single-group, quasi-experimental design was used.

Numerical rating scale (NRS)

Participants had an overall decrease in pain. Mean value at the beginning of treatment was 5.4 for those with cancer and decreased to 1.4 at the end of the second week (p < 0.0001) and to 2.6 at the two-week poststudy follow-up (p < 0.0001). After the tenth day of treatment, mean value was 2.9 (p < 0.0001), and after the second week of follow-up, the mean one month of treatment pain reduction was 4.0 and 5.2 in patients with cancer and noncancer patients, respectively. No side effects were reported. Among those patients with cancer-related pain, 64% were deemed complete responders, and 7% achieved a partial response. No adverse effects were seen.

This pilot study demonstrated that cutaneous electrostimulation with the MC5-A Calmare® device was effective in chronic pain treatment.

• The sample was small, with less than 100 participants.
• The study had a limited follow-up time frame.

Findings suggest that use of this device may provide benefit as adjunctive treatment for chronic pain control. Further well-designed research is needed to validate findings further.