MC5-A Scrambler Therapy for the Treatment of Neuropathic Extremity Pain

With greater than 90% survivability from combat-related traumatic injuries, acute and chronic pain are prevalent conditions among returning Service Members (SMs).The FDA-approved MC5-A Scrambler Therapy (ST) is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a message of normality (sans pain) to the central nervous system.  While preliminary research has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain secondary to traumatic musculoskeletal injuries like those experienced in combat has not been investigated. The aims of this double blind, randomized-controlled study are to: (1) determine the efficacy of ST in reducing chronic neuropathic pain intensity and opioid analgesic medication consumption in service members with musculoskeletal extremity injuries, when compared to sham treatment; (2) determine whether ST treatment produces any variability in the biopsychosocial secondary sequelae of chronic pain (depression, anxiety, post-traumatic stress, sleep quality, mental and physical well-being, social support, social conflict) when compared to sham treatment; and (3) assess the participants’ perceptions of treatment acceptability and tolerability of the treatment. A sample of 130 active duty SMs with chronic neuropathic extremity pain secondary to a traumatic injury will be recruited and randomly allocated to receive ST treatment or sham treatment. Data collection will occur at baseline, post-treatment (4 weeks), and 1 month follow-up using the following instruments: Demographic Survey; Pain Numerical Rating Scale; Daily Pain Diary Treatment Log; Patient Health Questionnaire; Generalized Anxiety Disorder; Pittsburg Sleep Quality Index; Posttraumatic Stress Checklist (PCL-M); Short Form Health Survey, version 2; and Interpersonal Relationship Inventory (IPRI). Data analyses will include descriptive statistics, and a two-factor generalized linear mixed model  (treatment, time) with repeated measures on the factor time, followed by two-tailed, non-parametric rank based tests corrected for multple comparisons.

Final Report is available on NTRL: https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB2018100...