Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS
- Conditions
- Tinnitus
- Interventions
- Procedure: Acupuncture
- Registration Number
- NCT05829278
- Lead Sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture group Acupuncture Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
the Third Affiliated Hospital of Zhejiang Chinese Medical University
🇨🇳Hangzhou, Zhejiang, China