The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- OAB symptom score (OABSS)
研究概览
简要总结
Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence, daytime frequency and nocturia. Urgency incontinence is more common in older women and may be associated with comorbid conditions that occur with age. The standard OAB medical treatments may induced several intolerable side effects including dry mouth, constipation, and so on, therefore alternative therapies are often considered. Acupuncture had been proved effective to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser acupuncture has minimal side effects comparing to conventional acupuncture, but its effects against OAB had never been examined. Experiments with laser acupuncture are expected to be another way to relieve OAB symptoms.
详细描述
The subjects are treated with 7 acupoints which are localized according to WHO standardized acupressure point location guideline. The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints mentioned above. The experimental group (verum laser acupuncture) and control group (sham laser acupuncture) will receive laser acupuncture 3 times per week for 3 weeks, total of 9 sessions, based on clinical experience (Treatment could be extended if necessary). The basic patient data will be recorded at baseline and adverse effect will also be recorded during the clinical trial.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women are older than 18 years old.
- •Participant is willing to sign the consent.
- •Women havea moderate OAB symptoms.
- •Total scores of OABSS > 6 points and the 3rd question of OABSS > 2 points.
- •Not using anticholinergic drugs for more than three weeks.
排除标准
- •Patients with lower urinary tract infection.
- •Patients who cannot complete the questionnaire.
- •Patients who use Botox to inject bladder and pelvic floor muscles within one year.
- •Pregnant patients.
- •Patients who continue to have electrical stimulation and acupuncture in the legs, waist and pelvis.
- •Patients with vaginal bleeding.
- •Other herbal and folklore therapies are being used to improve patients with overactive bladder.
研究组 & 干预措施
Verum laser acupuncture
Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .
干预措施: Verum laser acupuncture (Device)
Sham laser acupuncture
sham laser acupuncture (no laser output)
干预措施: Sham laser acupuncture (Device)
结局指标
主要结局
OAB symptom score (OABSS)
时间窗: 3 weeks
This is a four symptoms questionnaire to quantify OAB symptoms.
次要结局
- The Urogenital Distress Inventory (UDI-6)(3 weeks)