Steinhauser Stephan, Ganter Michael Thomas, Stadelmann Vincent, Hofer Christoph Karl
Division of Anaesthesia, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland.
Institute of Anaesthesiology and Intensive Care Medicine, Hirslanden Clinic, Zurich, Switzerland.
Pain Ther. 2024 Feb;13(1):69-85. doi: 10.1007/s40122-023-00560-8. Epub 2023 Nov 28.
In the treatment of patients with chronic pain, whole-body electrostatic therapy using the Elosan Cabin C1 has been proposed as an adjunctive therapy. So far, data on the use of this cabin are limited. Promising results with a significant reduction in pain scores have been obtained in a small group of patients. However, treatment with Elosan Cabin C1 has not been the subject of evaluation in a larger patient population. The aim of this study was to investigate the efficacy and adverse effects of electrostatic treatment in such a population.
Prospective, multi-center, observational clinical trial conducted in daily practice in a large adult ambulatory population with chronic pain. Each patient received eight weekly Elosan C1 treatment sessions for up to 9 weeks. Treatment was added to an established conservative pain management. Pain scores (visual analog scale (VAS) 0-100, primary outcome) and sleep quality (seven-point Likert scale, secondary outcome) were assessed before, during, and at the end of the treatment period; quality of life (SF-12: Physical Component Summary = PCS, Mental Component Summary = MCS; secondary outcome) was assessed before and at the end of the treatment period. Subgroup analyses were performed for sex, age, duration of pain, initial pain location, pain entity, and pain medication at the start of treatment.
A total of 192 patients were enrolled, 143 patients (74.5%) had a complete set of 8 treatment sessions. A reduction in pain scores from 68 ± 14 points to 47 ± 22 points was observed (p < 0.001), 65% of patients (responders) had a reduction of > 15 points. Female patients had a significantly better response than male patients with a higher number of responders (76% vs. 38%; p < 0.001). Patients with a pain history < 1 year had a significantly better response than patients with a pain history > 1 year. The Physical Component Summary (PCS) increased from 36 ± 11 to 41 ± 11 (+ 18%, p < 0.001) and the Mental Component Summary (MCS) from 41 ± 7 to 43 ± 7 (+ 6%, p = 0.3). Overall sleep quality improved significantly from 4.6 ± 1.7 to 3.73 ± 1.7 points (p < 0.001), with a higher proportion of responders in the female group (37 vs. 18%; p < 0.034). No serious adverse events were observed during treatment.
Electrostatic therapy with Elosan Cabin C1 may be a useful and effective adjunct therapy for patients with chronic pain. The results suggest that female patients and those with a recent history of pain experience the greatest benefit.
NCT04818294 (clinicaltrials.gov).
在慢性疼痛患者的治疗中,有人提出使用Elosan Cabin C1全身静电疗法作为辅助治疗方法。到目前为止,关于该设备使用的数据有限。在一小部分患者中已取得了有前景的结果,疼痛评分显著降低。然而,Elosan Cabin C1治疗尚未在更大规模的患者群体中进行评估。本研究的目的是调查在这样的群体中静电治疗的疗效和不良反应。
在日常实践中,针对一大群患有慢性疼痛的成年门诊患者进行了一项前瞻性、多中心、观察性临床试验。每位患者每周接受8次Elosan C1治疗,疗程长达9周。治疗被添加到既定的保守疼痛管理方案中。在治疗期开始前、治疗期间和结束时评估疼痛评分(视觉模拟量表(VAS)0 - 100,主要结局)和睡眠质量(七点李克特量表,次要结局);在治疗期开始前和结束时评估生活质量(SF - 12:身体成分总结 = PCS,心理成分总结 = MCS;次要结局)。对治疗开始时的性别、年龄、疼痛持续时间、初始疼痛部位、疼痛类型和疼痛用药情况进行亚组分析。
共纳入192例患者,143例患者(74.5%)完成了全套8次治疗。观察到疼痛评分从68±14分降至47±22分(p < 0.001),65%的患者(反应者)疼痛评分降低超过15分。女性患者的反应明显优于男性患者,反应者数量更多(76%对38%;p < 0.001)。疼痛病史<1年的患者反应明显优于疼痛病史>1年的患者。身体成分总结(PCS)从36±11增加到41±11(+18%,p < 0.001),心理成分总结(MCS)从41±7增加到43±7(+6%,p = 0.3)。总体睡眠质量从4.6±1.7分显著改善至3.73±1.7分(p < 0.001),女性组反应者比例更高(37%对18%;p < 0.034)。治疗期间未观察到严重不良事件。
使用Elosan Cabin C1进行静电疗法可能是慢性疼痛患者一种有用且有效的辅助治疗方法。结果表明女性患者和近期有疼痛病史的患者受益最大。
NCT04818294(clinicaltrials.gov)