Acupuncture as complementary treatment for acute tinnitus - a pilot study

Not Applicable

• Conditions: acute tinnitus; H93.1; Tinnitus

• Registration Number: DRKS00012464
• Lead Sponsor: niversität Heidelberg, Abteilung Allgemeinmedizin und Versorgungsforschung

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.

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-07-31
• Study Start: 2017-05-30
• Results First Posted: 2020-07-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

tinnitus < 3 months

Exclusion Criteria

serious acute illness
no German speaking

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for tinniitus severity directly at the end of the acupuncture treatment

Secondary Outcome Measures

Name	Time	Method
Tinnitus funtional Index (TFI), Mini Tinnitus Questionnaire (Mini TF),<br>audiometry