Managing chronic pain: results from an open-label study using MC5-A Calmare® device
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.
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.
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.
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.
KeywordsPain Pain management Electrocutaneous stimulation Scrambler therapy
- 5.Von Roenn J, Cleeland C, Gonin R, Hatfield A, Pandya K (1993) Physician attitudes and practice in cancer pain management. A survey from the Eastern Cooperative Oncology Group. Ann Intern Med 119:121–126Google Scholar
- 6.Agency for Health Care Policy and Research (1994) Clinical practice guideline cancer pain management. US Department of Health and Human Services, RockvilleGoogle Scholar
- 9.American Society of Anesthesiologists Task Force on Chronic Pain Management; American Society of Regional Anesthesia and Pain Medicine (2010) Practice guidelines for chronic pain management. Anesthesiology 112:810–833Google Scholar
- 14.Mailis-Gagnon A, Furlan A, Sandoval J, Taylor R (2003) Spinal cord stimulation for chronic pain. Cochrane Database Syst Rev 3:CD003783Google Scholar
- 15.Khadikar A, Milne S, Brosseau L, Robinson V, Saginur M, Shea B, Tugwell P, Wells G (2005) Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Cochrane Database Syst Rev 4:CD003008Google Scholar
- 20.Gatti A, Sabato AF, Marineo G (2007) Scrambler therapy in neuropathic pain. Pathos 14:99–105Google Scholar
- 21.Caraceni A, Cherny N, Fainsinger R, Kaasa S, Poulain P, Radbruch L, De Conno F (2002) Pain measurement tools and methods in clinical research in palliative care: recommendations of an expert working group of European Association of Palliative Care. J Pain Symptom Manage 23:239–255PubMedCrossRefGoogle Scholar
- 26.Mercadante S (2006) Pathophysiology of chronic pain. In: Bruera E, Higginson IJ, Ripamonti C, von Gunten C (eds) Textbook of palliative medicine. Hodder Arnold, London, pp 359–366Google Scholar
- 27.Ricci M, Pirotti S, Burgio M, Scarpi E, Sansoni E, Ridolfi R, Amadori D, Maltoni M (2010) Safety and efficacy of scrambler therapy for cancer pain. J Clin Oncol 28 (suppl; abstr e19591)Google Scholar