Scrambler therapy in the management of somatosensory signs and symptoms related to neuropathic pain: an exploratory and prospective analysis

Abstract

Objectives: Neuropathic pain is a severe and disabling health problem, often difficult to treat and characterized by specific somatosensory signs and symptoms. The goal of this study is to detect the effect of Scrambler therapy (ST) on the reset of Neuropathic Pain Diagnostic Questionnaire (DN4), in a cohort of patients affected by intense drug-resistant neuropathic pain. Methods: Patients with chronic neuropathic pain were consecutively enrolled to receive 45-minute daily ST for an average of 10 consecutive days. Evaluation of pain intensity by Numerical Rating Scale (NRS) score and DN4 questionnaire was performed at the beginning and at the end of the treatment. Primary endpoint was to achieve a significant negativization of DN4 (DN4 <4) in the study population after 10 ST sessions. Secondary endpoints were to detect a correlation between DN4 negativization and pain intensity reduction ≥50% (patient responders), finally to analyse the impact of ST on each item of DN4 survey. Results: We prospectively treated 45 patients. Mean baseline DN4 score was 5.67 [±1.43] and fell by 50.3%, with a mean DN4 score of 2.82 [±2.18] at the end of treatment (OR 2.84; 95%CI: 2.07-3.62; p<0.0001). In 28 out of 45 (62.2%) patients we reported a negativisation of DN4 (p<0.0001). Correlation between the percentage of patient responders and patients with negativization of DN4 was statistically significant (p<0.0062). Analysing each DN4 item pre- and post-ST, we reported a significant negativization in 6 out of 10 DN4 items. Discussion: Our prospective exploratory analysis met the primary endpoint and ST seems to resolve relevant somatosensory signs and symptoms related to neuropathic pain. Based on these encouraging results, the next step will be to evaluate these neuropathic pain features with dedicated tools.