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临床试验/DRKS00012464
DRKS00012464已完成未知

Acupuncture as complementary treatment for acute tinnitus - a pilot study

niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung0 个研究点目标入组 50 人开始时间: 2017年5月30日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
50

研究概览

简要总结

Background: Up to now, tinnitus has been an almost non-treatable symptom affecting more than 18% of the population in industrialized countries. So far, there are only a few studies evaluating the effectiveness of acupuncture in tinnitus treatment, none of which include acute tinnitus (<3 months). The aim of this pilot study was to explore the feasibility of recruitment and adherence to acupuncture conducted according to the principles of traditional Chinese medicine in patients with acute idiopathic tinnitus and to assess effect sizes on subjective and objective outcomes within a randomized controlled design. Patients and methods: After randomization patients of the control group received usual care (n = 23), and patients of the intervention group (n = 25) received 4 additional acupuncture treatments in a 4- to 6-week period. Tinnitus severity was assessed by means of a visual analogue scale as well as standardized and validated tinnitus questionnaires (Tinnitus Functional Index and 12-item Mini Tinnitus Questionnaire) at baseline and 6 weeks after. These subjective parameters were completed by tone audiometry. Comparisons of the groups were carried out using the Wilcoxon-Mann-Whitney test. Results: Both groups were comparable without significant differences in baseline values. All outcomes, except for the overall well-being, showed better improvements in the intervention group with clinically significant differences from baseline to end point. However, among the outcomes only the subjective change in tinnitus severity showed a significant group difference. No serious side effects were observed. Conclusion: The design of our pilot study was feasible in terms of recruitment, although patient adherence to treatment remained challenging. However, considering the small intergroup differences, procedures regarding the numbers of acupuncture sessions and the total period of the acupuncture treatment should be reconsidered. The results of this pilot study provide a good basis for future confirmatory trials.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • tinnitus < 3 months

排除标准

  • serious acute illness
  • no German speaking

研究者

发起方
niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung

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