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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

Conditions: Tinnitus

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05829278

YLKY-2021-01-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

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

Treatment:

Procedure: Acupuncture

Waiting list group

No Intervention group

Description:

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.