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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829278
• Other study ID #: YLKY-2021-01-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Xiaoqi Lin, M.M
• Phone: 15017541801
• Email: linxq361[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.

2. Male and female, Aged between 18 and 60 years.

3. Participants can cooperate with experimental procedures and sign written inform consent.

4. Not participating in other clinical trials concurrently.

Exclusion Criteria:

1. Participants with objective tinnitus

2. Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity.

3. Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.

4. Participants have any contraindications for acupuncture (such as a bleeding tendency)

5. Pregnant or lactating women.

6. Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Kuzucu I, Karaca O. Acupuncture Treatment in Patients with Chronic Subjective Tinnitus: A Prospective, Randomized Study. Med Acupunct. 2020 Feb 1;32(1):24-28. doi: 10.1089/acu.2019.1367. Epub 2020 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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