Russo Domenico, Zoratto Federica, Tirocchi Gastone, Guarda Michela
Hospice, Casa di Cura "San Marco", Latina; Italy Algology Unit, Studio Polispecialiastico "Albamedica", Albano Laziale; Italy.
Hospice, Casa di Cura "San Marco", Latina; Italy.
Acta Biomed. 2018 Jun 7;89(2):180-185. doi: 10.23750/abm.v89i2.5704.
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.
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.
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.
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.
神经性疼痛是一个严重且致残的健康问题，通常难以治疗，并具有特定的躯体感觉体征和症状。本研究的目的是在一组患有严重耐药性神经性疼痛的患者中，检测扰频器疗法（ST）对重置神经性疼痛诊断问卷（DN4）的效果。
连续纳入慢性神经性疼痛患者，每天接受45分钟的ST治疗，平均连续治疗10天。在治疗开始和结束时，通过数字评分量表（NRS）评分和DN4问卷评估疼痛强度。主要终点是在进行10次ST治疗后，研究人群中DN4显著转阴（DN4<4）。次要终点是检测DN4转阴与疼痛强度降低≥50%（患者反应者）之间的相关性，最后分析ST对DN4调查各项的影响。
我们前瞻性地治疗了45例患者。基线时DN4平均评分为5.67[±1.43]，下降了50.3%，治疗结束时DN4平均评分为2.82[±2.18]（比值比2.84；95%置信区间：2.07-3.62；p<0.0001）。45例患者中有28例（62.2%）报告DN4转阴（p<0.0001）。患者反应者百分比与DN4转阴患者之间的相关性具有统计学意义（p<0.0062）。分析ST前后各DN4项目，我们报告10项DN4项目中有6项显著转阴。
我们的前瞻性探索性分析达到了主要终点，ST似乎解决了与神经性疼痛相关的相关躯体感觉体征和症状。基于这些令人鼓舞的结果，下一步将使用专用工具评估这些神经性疼痛特征。
