This randomized controlled pilot trial aims to explore the Efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS).
A total of 60 tinnitus patients were randomly assigned to either an acupuncture group or a waiting list group in a 1:1 ratio. Subjects in the acupuncture group will undergo 4-week acupuncture treatment, while subjects in the waiting list group will receive no treatment during the 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Change in resting-state functional connectivity (RSFC)
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Change in hemoglobin signals
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Change in Tinnitus Handicap Inventory score
Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Change in average pure-tone threshold
Average pure-tone threshold will be assessed by pure-tone audiometry.
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Change in Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a reliable indicator of the severity of anxiety symptoms. The Hamilton Anxiety Scale consists of 14 items, each rated on a 5-point scale from 0 to 4. A larger score indicates a more severe degree of anxiety.
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Change in tinnitus loudness
Tinnitus loudness will be measure by using an 11-point numerical rating scale, with 0 indicating no tinnitus and 10 indicating maximum intolerable tinnitus.
Time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
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