Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes

双盲 2 期随机对照试验：针灸对患者外阴痛结果的影响

• 批准号: 10172941
• 负责人: Judith Michelle Schlaeger
• 金额: $ 38.73万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172941
• 关键词: Acupuncture Points; Acupuncture Therapy; Affect; Age; Age-Years; American; Chinese People; Clinical; Coitus; Data; Diagnosis; Discipline of Nursing; Disease; Documentation; Double-Blind Method; Dyspareunia; Excision; Feasibility Studies; Female; Genital; Genitalia; Goals; Hour; Institutes; Life; Maintenance; Masks; Measures; Medical; Medicine; Mental Health; Needles; Occupations; Outcome; Pain; Pain intensity; Patients; Persons; Phase; Pilot Projects; Placebo Effect; Placebos; Population; Privatization; Procedures; Process; Protocols documentation; Publishing; Quality of life; Race; Randomized; Randomized Controlled Trials; Research; Sampling; Sex Functioning; Sexual Health; Skin; Standardization; Stimulus; Sting Injury; Subgroup; Syndrome; Tampons; Testing; Time; Touch sensation; Training; Treatment Protocols; United States National Institutes of Health; Vagina; Vestibulodynia; Vulva; Vulvodynia; Waiting Lists; Woman; Work; blind; clinically significant; college; community setting; design; exhaust; follow-up; group intervention; improved; indexing; insight; intervention effect; irritation; pain reduction; pain relief; pill; placebo group; primary outcome; public health relevance; recruit; secondary outcome; sex; sugar; treatment duration; treatment effect; virtual; vulvar pain

Abstract Our long-term goal is to demonstrate the effects of acupuncture for the treatment of vulvodynia. Up to 14 million American women have vulvodynia, a debilitating pain syndrome characterized by vulvar pain and dyspareunia that renders sexual intercourse virtually impossible. Although no therapies have been proven efficacious and rapid pain relief is unpredictable and rarely possible, there have been no sham control studies of acupuncture as a treatment for vulvodynia, a high priority population for several NIH institutes. In our recently published randomized wait-list controlled pilot study of 36 women with vulvodynia, we found a statistically and clinically significant reduction in vulvar pain and dyspareunia and an increase in overall sexual function after a 13-needle, 10-session acupuncture protocol. We have also demonstrated in a small pilot study that it is feasible to use double-blind needles in the same 13-needle, 10- session acupuncture protocol for the treatment of vulvodynia. We now propose a pretest/posttest randomized controlled, double- blind design to determine efficacy of this acupuncture treatment protocol. Subjects will be randomized 1:1 to either a penetrating needle group or a skin touch placebo needle group. The acupuncturist will be observed for fidelity in use of both types of needles, which are designed to blind both the acupuncturist and subject to the type of needle. Eighty subjects with vulvodynia will insert and remove a tampon as a standardized stimulus and complete measures of vulvar pain (average pain intensity from pain now, least and worst pain in the past 24 hours [PAINReportIt®]); and dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) at pretest (pretreatment baseline) and at posttest after the 10th acupuncture session. Specific aims are to: Aim 1. Compare the penetrating needle group and the skin touch placebo needle group for effects on the (a) primary outcome of vulvar pain (PAINReportIt® average pain intensity), and (b) secondary outcomes of dyspareunia (FSFI dyspareunia) and sexual function (FSFI total). Hypothesis: Controlling for baseline values, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over the five weeks in the penetrating needle group compared to the skin touch placebo group. Aim 2. In subjects with a clinically meaningful reduction in pain intensity (at least 1.5 points) at posttest compared to pretest, describe the duration of the acupuncture treatment and placebo effects weekly until pain returns to pretest or up to 12 weeks after posttest. We will describe the variability over time in vulvar pain intensity (0-10) after a tampon insertion-removal stimulus and thereby explore the duration of the effect by intervention group, vulvodynia subgroups, and demographic subgroups (age, race, occupation). These findings will provide important insights to guide future research on initial and maintenance acupuncture treatment protocols for control of vulvodynia pain.

摘要

项目成果

Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles.

对针灸师盲法的影响：不同直径的双盲针灸针。

• 发表时间: 2021
• 期刊: Alternative therapies in health and medicine
• 影响因子: 1.5
• 作者: Yajima,Hiroyoshi;Takayama,Miho;Nasu,Morihiro;Nishiwaki,Masako;Kawase,Akiko;Hiramatsu,You;Nobe,Ruka;Schlaeger,JudithM;Takakura,Nobuari
• 通讯作者: Takakura,Nobuari

Sensory pain characteristics of vulvodynia and their association with nociceptive and neuropathic pain: an online survey pilot study.

外阴痛的感觉疼痛特征及其与伤害性疼痛和神经性疼痛的关联：一项在线调查试点研究。

• DOI: 10.1097/pr9.0000000000000713
• 发表时间: 2019
• 期刊: Pain reports
• 影响因子: 4.8
• 作者: Schlaeger,JudithM;Patil,CrystalL;Steffen,AlanaD;Pauls,HeatherA;Roach,KeeshaL;Thornton,PatrickD;Hartmann,Dee;Kobak,WilliamH;Yao,Yingwei;Suarez,MarieL;Hughes,TondaL;Wilkie,DianaJ
• 通讯作者: Wilkie,DianaJ

Double-blind acupuncture needles: a multi-needle, multi-session randomized feasibility study.

• DOI: 10.1186/s40814-018-0265-9
• 发表时间: 2018
• 期刊: Pilot and feasibility studies
• 影响因子: 1.7
• 作者: Schlaeger JM;Takakura N;Yajima H;Takayama M;Steffen AD;Gabzdyl EM;Nisi RA;McGowan Gruber K;Bussell JM;Wilkie DJ
• 通讯作者: Wilkie DJ

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

• DOI: 10.1177/1740774520934910
• 发表时间: 2020-10
• 期刊: Clinical trials (London, England)
• 作者: Steffen AD;Burke LA;Pauls HA;Suarez ML;Yao Y;Kobak WH;Takayama M;Yajima H;Kaptchuk TJ;Takakura N;Wilkie DJ;Schlaeger JM
• 通讯作者: Schlaeger JM

Acupuncture for post-stroke shoulder pain: a case report.

针灸治疗中风后肩痛：病例报告。

• DOI: 10.1177/0964528420920292
• 发表时间: 2020
• 期刊: Acupuncture in medicine : journal of the British Medical Acupuncture Society
• 作者: Yajima,Hiroyoshi;Takayama,Miho;Nobe,Ruka;Schlaeger,JudithM;Takakura,Nobuari
• 通讯作者: Takakura,Nobuari