Scrambler therapy: what's new after 15 years? The results from 219 patients treated for chronic pain.

Chronic pain is often difficult to treat, requiring a comprehensive multidisciplinary therapeutic intervention and a high level of management expertise.This is particularly true for patients who are unresponsive to standard treatments for chronic pain, for which Scrambler Therapy (ST) is indicated. The aim of the present study was to evaluate the impact of ST on patient-reported moderate to severe chronic pain.This was a prospective trial on 219 patients affected by chronic pain from April 2010 to March 2016. The study consisted of 2 consecutive weeks of treatment with ST (one 30-min daily session, 5 days a week) (T0, T1, T2) and a 2-week follow-up (T3, T4). Patients were asked to describe the pain using the Numeric Rating Scale (NRS) immediately prior to and after the treatment.Two hundred nineteen patients were treated for chronic pain of different nature with mean values of 6.44 (± 2.11) at T0, 3.22 (± 2.20) at T2, and 3.19 (± 2.34) at T4. A reduction in the symptomatology from T0 to T2 was maintained throughout T4 (P value < .0001). Of the 219 patients treated with ST, 83 (37.9%) had cancer pain and 136 (62.1%) had non-cancer pain. No adverse events were reported.Future research should focus on individual response, retreatment, and maintenance therapy. The data showed a statistically significant impact of ST, which was maintained during follow-up, on patients suffering from chronic pain of different nature.

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

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.