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

NCT05829278 | Unknown

• 1 other identifier: YLKY-2021-01-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Tinnitus

Keywords

acupuncture; moxibustion; tinnitus; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Tinnitus Handicap Inventory score

  at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

• Change in average pure-tone threshold

  at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

• Change in Hamilton Anxiety Scale score

  at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

• Change in tinnitus loudness

  at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Procedure: Acupuncture

Waiting list group

NO INTERVENTION

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.

Interventions

Acupuncture PROCEDURE

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

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

• 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.

  PMID: 32104524 BACKGROUND

• 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.

  PMID: 37814607 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hantong Hu, M.D.

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqi Lin, M.M

CONTACT

15017541801; linxq361@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 25, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)