Effects of acupuncture on heart rate variability in adult tinnitus patients

Not Applicable

Completed

• Conditions: Tinnitus; Ear, Nose and Throat

• Registration Number: ISRCTN58013563
• Lead Sponsor: Beijing Municipal Health Bureau (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-03
• Study Completion: 2013-10-06
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Typical conditions of unilateral or bilateral tinnitus
2. Age 18-65 years, either sex
3. Tinnitus duration of more than 3 months
4. Not receive any treatment last 1 month
5. Normal language and intelligence ability to answer and fill in the questionnaire
6. Correct understanding of acupuncture, and good compliance to the research observation and evaluation
7. Written and informed consent

Exclusion Criteria

1. Objectivity tinnitus
2. Acute or intermittent tinnitus, history of Meniere disease or tinnitus induced by middle ear/inner ear/small pons Angle tumor
3. Underlying disease or history: otitis media, tympanic membrane perforation, eustachian tube function obstacle
4. Acoustic neuroma, Intracranial damage, inner ear disease or use of any ototoxic drugs
5. Severe dysfunction of heart, kidneys or liver
6. The serious original disease of hematopoietic system or endocrine system
7. Serious aphasia, depression syndrome or mental disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV), measured before and after the first acupuncture session, as well as 3 weeks after the whole acupuncture treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change of tinnitus severity according to the tinnitus questionnaire of Tinnitus Handicap Inventory (THI):<br> 1.1. F: Functional subscale (11 factors)<br> 1.2. E: Emotional subscale (9 factors)<br> 1.3. C: Catastrophic subscale (5 factors)<br> Each question of the THI can be answered by the patient with either often (2 points), sometimes (1 point) or never (0 points) with a maximum total score of 100 indicating most severe suffering from tinnitus. The assessment was before and after the first acupuncture session, as well as 3 weeks after the whole acupuncture treatment.<br> 2. Participants also reported adverse events they experienced, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each treatment.<br>