Clinical trial NCT05829278: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: acupuncture
moxibustion
tinnitus
randomized controlled trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in resting-state functional connectivity (RSFC)
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
measure: Change in hemoglobin signals
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Secondary outcomes:
measure: Change in Tinnitus Handicap Inventory score
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
measure: Change in average pure-tone threshold
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
measure: Change in Hamilton Anxiety Scale score
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
measure: Change in tinnitus loudness
timeFrame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Hantong Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.