Impact of Acupuncture on Vasomotor Rhinitis: a Randomised Placebo Controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).
研究概览
简要总结
Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common disease for which there are only poor therapeutic treatment options. The current placebo controlled partially double blinded pilot study evaluated the effects of acupuncture on the symptoms of vasomotor rhinitis.
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
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term of sickness > 3 month
- •negative allergic testing
排除标准
- •term of sickness < 3 month
- •previous nasal surgeries
- •polyposis nasi
- •contraindications regarding acupuncture (such as: risk of bleeding, pregnancy)
- •psychologic disorders
- •drug addiction
- •autoimmune disease
- •other severe disease
研究组 & 干预措施
Sham-laser acupuncture
The sham-laser acupuncture treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). Sham-laser acupuncture was applied at the same points as the acupuncture treatment. A deactivated laser pen (Seirin, 3B Scientific GmbH, Hamburg, Germany) that could only beam normal red light rather than laser was used. The total number of acupuncture points utilized was equal to the acupuncture group. Every point was treated for 30 sec with the total treatment time of 20 minutes.
干预措施: Sham-laser acupuncture (Device)
Acupuncture
The treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). The acupuncture treatment was semi-standardised. It consisted of a basic pool of 6 body acupuncture points. Five additional acupuncture body points together with auricular points formed an individual pool. After needle insertion, the needle was manipulated until the subject obtained the de-Qi response (a deep aching or full feeling at the needle, [22]). After obtaining the de-Qi response, there was no further manipulation of the needle. Each session lasted 20 minutes.
干预措施: Acupuncture (Device)
结局指标
主要结局
The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).
时间窗: 5 weeks
次要结局
- Secondary outcome measures were the evaluation of a subjective symptoms score by patients' diaries and of their quality of life (SF-12 health survey).(5 weeks)
