Back to resultsEfficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS
Primary Purpose
Tinnitus
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring acupuncture, moxibustion, tinnitus, randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- the Third Affiliated Hospital of Zhejiang Chinese Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture group
Waiting list group
Arm Description
Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
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.
Outcomes
Primary Outcome Measures
Change in resting-state functional connectivity (RSFC)
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Change in hemoglobin signals
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Secondary Outcome Measures
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.
Change in average pure-tone threshold
Average pure-tone threshold will be assessed by pure-tone audiometry.
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.
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.
Full Information
NCT ID
NCT05829278
First Posted
April 11, 2023
Last Updated
April 23, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05829278
Brief Title
Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS
Official Title
Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS: Study Protocol for a Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
acupuncture, moxibustion, tinnitus, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
Arm Title
Waiting list group
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.
Primary Outcome Measure Information:
Title
Change in resting-state functional connectivity (RSFC)
Description
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Title
Change in hemoglobin signals
Description
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Tinnitus Handicap Inventory score
Description
Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Title
Change in average pure-tone threshold
Description
Average pure-tone threshold will be assessed by pure-tone audiometry.
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Title
Change in Hamilton Anxiety Scale score
Description
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.
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Title
Change in tinnitus loudness
Description
Tinnitus loudness will be measure by using an 11-point numerical rating scale, with 0 indicating no tinnitus and 10 indicating maximum intolerable tinnitus.
Time Frame
at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoqi Lin, M.M
Phone
15017541801
Ext
86
Email
linxq361@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hantong Hu, M.D.
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hantong Hu, MD
Phone
18667103032
Ext
86
Email
413351308@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaoqi Lin, Ph.D
Phone
15017541803
Ext
86
Email
linxq361@163.com
First Name & Middle Initial & Last Name & Degree
Hantong Hu, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32104524
Citation
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.
Results Reference
background
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Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS
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