Tinnitus
Conditions
Keywords
acupuncture, moxibustion, tinnitus, randomized controlled trial
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.
Interventions
PROCEDUREAcupuncture
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in resting-state functional connectivity (RSFC) | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | RSFC will be measured by functional near-infrared spectroscopy (fNIRS). |
| Change in hemoglobin signals | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Handicap Inventory score | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | 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 | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | Average pure-tone threshold will be assessed by pure-tone audiometry. |
| Change in Hamilton Anxiety Scale score | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | 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 | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up | Tinnitus loudness will be measure by using an 11-point numerical rating scale, with 0 indicating no tinnitus and 10 indicating maximum intolerable tinnitus. |
Countries
China
Contacts
Primary ContactXiaoqi Lin, M.M
Outcome results
None listed