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

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05829278

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Tinnitus	Procedure: Acupuncture	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture group Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.	Procedure: Acupuncture Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.
No Intervention: Waiting list group 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.

Arm

Intervention/Treatment

Experimental: Acupuncture group

Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.

Procedure: Acupuncture

Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.

No Intervention: Waiting list group

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.

Outcome Measures

Primary Outcome Measures

Change in resting-state functional connectivity (RSFC) [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Change in hemoglobin signals [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).

Secondary Outcome Measures

Change in Tinnitus Handicap Inventory score [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Change in average pure-tone threshold [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
Average pure-tone threshold will be assessed by pure-tone audiometry.
Change in Hamilton Anxiety Scale score [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
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.
Change in tinnitus loudness [at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up]
Tinnitus loudness will be measure by using an 11-point numerical rating scale, with 0 indicating no tinnitus and 10 indicating maximum intolerable tinnitus.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.