Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS: Study Protocol for a Randomized Controlled Pilot Trial

Conditions
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Tinnitus

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus. Male and female, Aged between 18 and 60 years. Participants can cooperate with experimental procedures and sign written inform consent. Not participating in other clinical trials concurrently. Exclusion Criteria: Participants with objective tinnitus Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity. Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases. Participants have any contraindications for acupuncture (such as a bleeding tendency) Pregnant or lactating women. Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks. | Procedure: Acupuncture<br>* Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.<br>|
| No Intervention: Waiting list group<br>No intervention will be provided for the waiting list group and the subjects in this group will be followed during the 4-week observation period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting-state functional connectivity (RSFC) | RSFC will be measured by functional near-infrared spectroscopy (fNIRS). | 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). | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, moxibustion, tinnitus, randomized controlled trial