Pilot Clinical Trial of Two Acupuncture Protocols on Vulvodynia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Pain Score (objective)
研究概览
简要总结
Vulvodynia is a common condition in women (16%); however, at this time there is no known effective non-pharmacological therapy reported. Acupuncture is one complementary and alternative medicine therapy used by many patients with vulvodynia; some case reports show that acupuncture may be an effective intervention. In recent years, there were some studies registered took at like at actual trials of acupuncture on vulvodynia, but either they did not reach the trial aims, some studies did not get enough patients or the trial designs mimic drug studies and did not reflect acupuncture real characteristics.
This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. One third of the women will receive acupuncture focused on pudendal nerve distribution area; another one third of the women will receive acupuncture focused on traditional meridian points; the other one third of women will use standard care (without acupuncture). Women who get a reduction in pain (included in subjective and objective scores) will have their pain monitored once a week for up to 6 weeks to see if the acupuncture effect lasts.
详细描述
Aims of this study:
- Get preliminary data for future larger, randomized- controlled trials.
- See whether acupuncture is better than no-acupuncture treatments (where participations are following standard care for this condition), or at least have probable better outcomes than no acupuncture treatment (there may not be significance in statistics, given the small sample in current proposed trial);
- See if acupuncture group 1a (with focus on the points in pudendal nerve distribution near the pain area) has better results(at least, a trend) than acupuncture group 1b (traditional acupuncture focus on meridian or distal points).
The basic design and interventions:
- Diagnosis: Vulvodynia/Vulval pain by gynecologist or pain specialist/doctor, who will adopt International diagnose criteria.
- Patient sample (estimated): 17 in each acupuncture group (34 total), and 17 patients in the no-acupuncture group or standard care waiting list . Total 51 patients;
- Groups:
Group 1a (17 cases): acupuncture, using the local points in pudendal nerve distribution area (tender points, and up to two other set of acupuncture points); Group 1b (17 cases): traditional acupuncture, using common meridian or distal points; Group 2 (17 cases): standard care, waiting list. This group will receive no acupuncture treatment. 4. Randomized method: If the patient feels comfortable with acupuncture, they will be randomly assigned to either Group 1a or Group1b using randomization numbers generated by computer; if the patients still are under the treatments of routine conventional treatments, such as using pain medications, local injections, and physical therapies, or other non-surgical procedure, they will serve as participants in the standard care group, the waiting list. 5. Blind Method: Patients will be blind as to the purpose of the study as well as to the groups that they are assigned too. Each participant in either group 1a or 1b will receive actual, real acupuncture treatment but, depending on their group assignment, the strategy and points used will vary. 6. Treatments:
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)
盲法说明
All participants will get real treatments, the first group patients will get acupuncture treatments focus on the points within pudendal nerve distribution area; the second group patients will get acupuncture treatments focus on the points from traditional meridian theory. And the third group will get the standard care (no acupuncture). Participants and outcomes assessor will be blinded for the study aims.
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
- •diagnosis of generalized vulvodynia or provoked vestibulodynia by OB/GYN doctor(s) or pain specialist(s); 18 to 45 years old.
- •Current pain score 4 or higher with tampon insertion and removal performed, or cotton swab test, at the initial screening exam
- •speak and read English or Chinese.
排除标准
- •infectious conditions of the vulvar/vagina;
- •inflammatory conditions of the vulvar/vagina;
- •neoplastic disorders of the vulvar/vagina;
- •neurologic disorders of the vulvar/vagina;
- •acute trauma to the genitals;
- •iatrogenic conditions of the genitals
- •hormonal deficiencies
- •co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
- •patients have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.
结局指标
主要结局
Pain Score (objective)
时间窗: at the end of 6 weeks
Figure out the pain score using Visual Analog pain scale(VAS) using cotton swab , \[score 0-no pain, 10-strongest (unbearable) pain\]. Expected clinical significant difference (ECSD): 3.
次要结局
- Pain Score (Subjective)(at the end of 6 weeks)
- Pain duration(at the end of 6 weeks)
- Intercourse pain(at the end of 6 weeks)
研究者
Arthur Fan
Director,Principal Investigator
McLean Center for Complementary and Alternative Medicine, PLC