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

NCT ID: NCT05829278

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2025-06-30

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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture group

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hantong Hu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hantong Hu, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Xiaoqi Lin, M.M

Role: CONTACT

15017541801 ext. 86

Facility Contacts

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Hantong Hu, MD

Role: primary

18667103032 ext. 86

Xiaoqi Lin, Ph.D

Role: backup

15017541803 ext. 86

References

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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.

Reference Type BACKGROUND
PMID: 32104524 (View on PubMed)

Hu H, Lin X, Fang L, Li Y, Gao H. Evaluating the Efficacy and Underlying Mechanisms of Acupuncture for Chronic Subjective Tinnitus Using Functional Near-Infrared Spectroscopy: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2023 Oct 4;16:3367-3378. doi: 10.2147/JPR.S433048. eCollection 2023.

Reference Type DERIVED
PMID: 37814607 (View on PubMed)

Other Identifiers

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YLKY-2021-01-01

Identifier Type: -

Identifier Source: org_study_id

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