Protocol for double-blind RCT of acupuncture for vulvodynia.
Protocol for double-blind RCT of acupuncture for vulvodynia.
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DOI：
10.1016/j.conctc.2022.101029
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发表时间：
2022-12
影响因子：
1.5
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外阴疼痛是一种原因不明的外阴疼痛，持续至少3个月，影响7%的美国女性。它的经常伴侣性交困难使得性交几乎是不可能的。尽管几乎没有有效的治疗方法，快速缓解疼痛的可能性也很小，但还没有关于针灸治疗外阴疼痛的假/安慰剂对照研究。目的：1)确定针刺治疗外阴疼痛的疗效；2)探讨针刺治疗外阴痛的持续时间。在一项标准化针灸方案的前测/后测随机对照、双盲(医生-患者)疗效试验中，我们将80名参与者1：1随机分为透针组或皮肤接触安慰剂组。这两种针头都是为了使针灸医生和参与者失明而设计的。有外阴疼痛的参与者将在第10次针灸治疗后插入和取出作为标准化刺激的卫生棉条，并完成外阴疼痛的主要测量(疼痛强度)和性功能障碍的辅助测量(女性性功能指数，FSFI性交困难子量表评分)和性功能(FSFI总分)的预处理，每周测量疼痛，直到恢复到测试前的水平。在研究完成后，控制组参与者将获得10次免费的真正针灸治疗。这是第一次使用双盲针灸针灸作为可靠的假针灸的多针多疗程RCT。我们假设，在控制基线的情况下，在后测试中，与皮肤触摸安慰剂组相比，穿刺组在五周内外阴疼痛和性交困难的发生率将显著减少，性功能更强。这项研究是对外阴疼痛妇女有效的疼痛管理的需求做出的反应。ClinicalTrials.gov标识：NCT03364127。
Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. This study is responsive to the need for efficacious pain management for women with vulvodynia. ClinicalTrials.gov Identifier: NCT03364127.