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Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia—A Randomized, Placebo-Controlled Pilot Trial

机译:低水平的激光治疗,用于治疗令人挑逗的前胃痛 - A随机,安慰剂控制的试验试验

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Abstract Background Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure. Aim To investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial. Methods Patients with PVD were randomly assigned to receive treatment with LLLT or sham treatment. Patients were treated twice weekly for 6 weeks, for a total of 12 LLLT or placebo sessions. Patients who showed improvement after LLLT were followed for 1 year by clinical pain report and Q-tip examination. Outcomes Change in pain scores obtained in response to the Q-tip test, clinical pain report, visual analog scale score, pain with tampon insertion, daily pain intensity, intercourse pain intensity, frequency of intercourse, and a battery of quality-of-life measures. Results Thirty-four patients with PVD participated, 18 received LLLT and 16 received placebo. In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group ( P ?= .042). This effect was not apparent in other outcome measurements. None of the patients reported side effects during the study. At 1-year follow-up, eight patients (57%) reported lasting improvement. Clinical Implications Larger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy. Strengths and Limitations Strengths include a placebo-controlled, double-blinded design, measurement of a large number of multidimensional end points, and a follow-up period of 1 year. Limitations include the small number of patients recruited, no improvement in measurable parameters, a high improvement rate in the placebo group, the absence of use of validated questionnaires, and the lack of evaluation of psychological and interpersonal factors that might have influenced the results. Conclusions Given the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia—A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403–1411.
机译:摘要背景低级激光疗法(LLLT)是一种新兴的医疗技术,其中应用非热激光照射来治疗疼痛。由于已经发现LLLT有效地治疗没有已知副作用的各种疼痛综合征,所以我们进行了一项研究评估LLLT对令人挑致的前虫害病毒病(PVD)的影响,其特征在于呼吸到外阴前庭的复杂性疼痛障碍,以应对接触或压力。旨在探讨LLLT在随机,安慰剂控制,双盲试验中PVD的有效性。方法将PVD患者随机分配接受LLLT或假处理治疗。患者每周治疗两次6周,共有12个lllt或安慰剂会话。通过临床疼痛报告和Q-TIP检查,术后1年后显示出改善的患者。结果改变疼痛评分响应Q-tip试验,临床疼痛报告,视觉模拟规模得分,止棉粥插入,日常疼痛强度,性交疼痛强度,性交频率,以及寿命的电池措施。结果34名PVD患者参加,18名接受了LLLT和16名接受的安慰剂。在学习完成的临床疼痛报告中,18名患者中的14名(78%)接受LLLT报告的改善,而安慰剂组中的7个(44%)(p?= .042)。在其他结果测量中,这种效果并不明显。在研究期间没有患者报告副作用。在1年的随访中,八名患者(57%)报告持久改善。临床意义需要使用各种治疗方案的较大研究来定义哪些患者可以从LLLT治疗中受益。优势和限制优势包括安慰剂控制,双盲设计,测量大量多维终点,以及1年的后续期间。局限性包括较少数量的患者招募,没有改善可测量的参数,安慰剂组的高度提高,没有使用过的问卷,缺乏可能影响结果的心理和人际因素的评价。结论鉴于该试点研究的结果,目前不能推荐LLLT作为PVD的治疗。需要更大的人群,各种治疗方案和LLLT在PVD的不同亚组中进行进一步的研究,以确定哪些患者可以从这种疗法中受益。 Lev-Sagie A,Kopitman A,Brzezinski A.低水平激光治疗用于治疗挑衅的前胃痛 - A随机,安慰剂控制的试验试验。 J SEX MED 2017; 14:1403-1411。

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