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振动或经皮胫神经刺激治疗女性脊髓损伤后性功能障碍的随机临床试验研究方案。

Vibration or Transcutaneous Tibial Nerve Stimulation as a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: Study Protocol for a Randomized Clinical Trial.

机构信息

Department of Physiotherapy, Aranjuez Nursing Home Center, 28300 Madrid, Spain.

Department of Physiotherapy, Faculty of Science Health, University of Málaga, 29016 Málaga, Spain.

出版信息

Int J Environ Res Public Health. 2022 Jan 28;19(3):1478. doi: 10.3390/ijerph19031478.

Abstract

BACKGROUND

Women with spinal cord injuries usually suffer from sexual dysfunction, such as alterations during arousal and an increase in the time to reach orgasm. However, little evidence has been found on its physiotherapeutic approach, as well as poor adherence to the latter. The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation.

METHODS

This is a randomized clinical trial that will recruit 54 women who, one year after a spinal cord injury, suffer from sexual dysfunction associated with the latter. The participants will be randomized to three groups: (a) intervention group 1 treated with transcutaneous tibial nerve electrostimulation ( = 18), (b) intervention group 2 treated with genital vibration ( = 18), and (c) a control group ( = 18). The treatment time will be 12 weeks. Adherence to the treatment will be evaluated, as well as the effectiveness of the treatment, through the Female Sexual Function Index, the Sexual Quality of Life-Female questionnaire, quantitative sensory tests, and the improvement reported by the patient in terms of arousal and orgasm. The evaluations will be carried out before the treatment, at the end of the treatment and 3, 6 and 12 months after the end of the treatment.

摘要

背景

脊髓损伤女性通常会出现性功能障碍,如性唤起时的改变和达到性高潮的时间增加。然而,关于其物理治疗方法的证据很少,而且后者的依从性也很差。本研究旨在确定两种改善性功能障碍的干预措施的有效性:生殖器振动和经皮胫神经电刺激的应用。

方法

这是一项随机临床试验,将招募 54 名在脊髓损伤一年后患有与后者相关的性功能障碍的女性。参与者将被随机分为三组:(a)经皮胫神经电刺激治疗的干预组 1(n=18),(b)生殖器振动治疗的干预组 2(n=18),和(c)对照组(n=18)。治疗时间为 12 周。将评估治疗的依从性以及通过女性性功能指数、女性性生活质量问卷、定量感觉测试以及患者在性唤起和性高潮方面报告的改善来评估治疗的效果。评估将在治疗前、治疗结束时以及治疗结束后 3、6 和 12 个月进行。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ff5/8835312/fd757bed113f/ijerph-19-01478-g001.jpg

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