Skip to main content
Clinical Trials/DRKS00012464
DRKS00012464
Completed
未知

Acupuncture as complementary treatment for acute tinnitus - a pilot study

niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung0 sites50 target enrollmentMay 30, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
acute tinnitus
Sponsor
niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung
Enrollment
50
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
who.int
Start Date
May 30, 2017
End Date
July 31, 2015
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung

Eligibility Criteria

Inclusion Criteria

  • tinnitus \< 3 months

Exclusion Criteria

  • serious acute illness
  • no German speaking

Outcomes

Primary Outcomes

Not specified

Similar Trials