Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Tampon Test
研究概览
简要总结
The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.
详细描述
This is a randomized, controlled, single-blinded, pilot trial to study the feasibility and acceptability of acupuncture and 5% lidocaine. Patients will be recruited from the patient population of the Oregon Health & Science University Vulvar Health Clinic. Thirty (30) patients with PLV will be enrolled as study participants into the study. Fifteen (15) will be allocated in the treatment (classical) acupuncture + 5% lidocaine group and fifteen (15) will be allocated in the control (non-classical) acupuncture + 5% lidocaine group via a computer generated randomization program to balance allocation based on four variables: pain intensity, smoking status, body mass index, and pain duration.
The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia
- •Reported introital dyspareunia longer than three months duration;
- •Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test;
- •Able to insert an Original Regular Tampax™ tampon.
排除标准
- •Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection).
- •Pregnant or postpartum and breastfeeding;
- •Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed;
- •Postmenopausal as defined by surgical or natural menopause (no menses for 12 months);
- •Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration;
- •Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months).
- •Use of SNRIs, lidocaine, or acupuncture within the last three months.
研究组 & 干预措施
Classical Acupuncture + Lidocaine
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
干预措施: Classical Acupuncture (Procedure)
Classical Acupuncture + Lidocaine
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
干预措施: Lidocaine (Drug)
Non-classical acupuncture + lidocaine
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
干预措施: Non-classical acupuncture (Procedure)
Non-classical acupuncture + lidocaine
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
干预措施: Lidocaine (Drug)
结局指标
主要结局
Tampon Test
时间窗: Weeks 1 and 12 study period
Primary outcome variable will be to measure the change in the reported pain of the "Tampon Test" (mean at Week 1) to the reported pain of "Tampon Test" (mean of Week 12); Every week, study participants will be asked to fully insert and remove a tampon and rate the level of pain with insertion on a 10-point Visual Analog Scale (0 indicating no pain, 10 indication worst possible pain).
次要结局
- Expectation(Week 1)
- Tampon Test(Weeks 1 and 6; Weeks 1 and 24)
- Cotton Swab test(Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.)
- Patient Reported Outcomes Measurement Information System (PROMIS) Scales(At baseline visit, 6 weeks, 12 weeks, and 24 weeks)
- Satisfaction(Weeks 12 and 24)
- Feasibility(Weeks 12 and 24)
- Acceptability(Weeks 12 and 24)
研究者
Lee Hullender Rubin, DAOM, LAc
Adjunct Research Faculty
Oregon College of Oriental Medicine