A Double-Blind Study on the Effectiveness of Polarized Light Therapy in the Treatment of Venous leg Ulcers-Pilot Study.

Jarosław Pasek, Sebastian Szajkowski, Grzegorz Cieślar
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Abstract

Vein diseases are one of the most common civilization diseases. The most advanced form chronic venous insufficiency are venous leg ulcers. The study included 40 patients, 20 male (50%) and 20 female (50%) in age between 52 and 88 years (mean age: 68.00 ± 8.55 years) with venous leg ulcers lasting 12.50 ± 5.45 months. Patients were distributed randomly in a double-blind study into two equal groups including 20 patients each (group 1-polarized light therapy and group 2-sham exposure). Patients from both groups received routine pharmacological treatment, specialistic medical dressings and compression therapy. In addition, patients were exposed to a cycle of polarized light therapy procedures or to sham exposures (30 procedures performed in two series of 15 procedures). Wound surface area was evaluated by computerized planimetry and pain intensity was assessed with the use of Visual Analog Scale (VAS) before and after therapy (2.5 months). The analysis showed a statistically significant reduction of surface ulcers area between groups 1 and 2. The median (IQR) size of wounds in group 1 was 2.4 (1.95-2.9) cm2, in group 2; 2.8 (2.6-3.1) cm2 (p = 0.038). The level of pain (VAS) after treatment was assessed in group 1, median (IQR): 2 (2-3) points, in group 2 4.5 (4-5) points; and the observed difference was also statistically significant (p < 0.001). In group 1, after treatment, the area of ulcers decreased-median (IQR): 33.05 (28.7-41.48) %, in group 2 by 18.99 (15-24.4) % (p < 0.001). In group 1, the pain intensity measured using the VAS scale decreased with a median (IQR): 71.42 (61.25-71.42) %, in group 2: 37.5 (28.57-50) % (p < 0.001). Complex therapy with polarized light therapy added to standard care was more effective than standard care alone in reducing of ulcers surface area and intensity of pain ailments in patients with chronic venous leg ulcers.

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偏振光疗法治疗静脉腿部溃疡疗效的双盲试验研究
静脉疾病是最常见的文明病之一。腿部静脉溃疡是慢性静脉功能不全的晚期表现。该研究包括 40 名腿部静脉溃疡患者,其中男性 20 名(50%),女性 20 名(50%),年龄在 52 岁至 88 岁之间(平均年龄:68.00 ± 8.55 岁),病程为 12.50 ± 5.45 个月。在双盲研究中,患者被随机分为两组,每组 20 人(第 1 组--偏振光疗法,第 2 组--岑照射)。两组患者均接受常规药物治疗、专业医用敷料和压力疗法。此外,患者还接受了一个周期的偏振光治疗或假照射(两个系列共进行了 30 次,每次 15 次)。治疗前后(2.5 个月)的伤口表面积由计算机平面测量法进行评估,疼痛强度由视觉模拟量表(VAS)进行评估。分析结果显示,第 1 组和第 2 组的表面溃疡面积明显减少。第 1 组伤口面积的中位数(IQR)为 2.4(1.95-2.9)平方厘米,第 2 组为 2.8(2.6-3.1)平方厘米(P = 0.038)。治疗后疼痛程度(VAS)的评估结果是,第一组的中位数(IQR)为 2(2-3)分,第二组为 4.5(4-5)分;观察到的差异也有统计学意义(p p p
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