Interest of Auriculotherapy in the Treatment of Xerostomia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 65
- 试验地点
- 8
- 主要终点
- Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
研究概览
简要总结
The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old;
- •Complain about xerostomia after cervical irradiation in the context of ENT cancer;
- •End of radiotherapy> 3 months
- •Covered by a national healthcare insurance
- •Consent form signed.
- •Non inclusion Criteria:
- •Pregnant or breastfeeding women;
- •Local counterindication to auriculotherapy;
- •With anticoagulant treatment;
- •History or existing of hemophilia;
- •Valvular prosthesis;
- •Ear's pavilion infection;
- •Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
- •Having started in the 48 hours preceding the first auriculotherapy session, any new management of xerostomia and likely to interfere with the study (specific medication and/or complementary therapeutic management);
- •Difficulty to comply with the treatment, questionnaires or study protocol;
- •Being deprived of liberty or under guardianship.
排除标准
- 未提供
研究组 & 干预措施
Real Auriculotherapy
Patients benefit from 3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
干预措施: Specific auriculotherapy (Other)
Sham Auriculotherapy
Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.
干预措施: Non-specific auriculotherapy (Other)
结局指标
主要结局
Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
时间窗: 3 months
Show that auriculotherapy (treatment of specific points) is effective in the treatment of xerostomia compared to a "sham" treatment (treatment of non-specific points). The relative variation of salivary secretion "after treatment" compared to "before treatment" will be judged on the weight of 3 compresses left 5 minutes in the mouth: 2 in front of the openings of Sténon's canal and 1 on the buccal floor (orifice of Wharton's canal). Salivary secretion is measured by the weight in grams of the compresses left in the mouth. This measurement is performed at inclusion and after 3 months of treatment. The measurement is made with a jeweler-type precision balance.
次要结局
- Assess the effect of auriculotherapy on the subjective improvement of salivation(3 months)
- Assess the effect of auriculotherapy on the subjective improvement of clinical status(3 months)
- Assess the effect of auriculotherapy on quality of life(3 months)
- Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations(3 months)
- Assess the effect of auriculotherapy on anxiety and depression(3 months)
- Assess the effect of auriculotherapy on the wish to continue treatment(3 months)