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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up |
| Change in average pure-tone threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoqi Lin, M.M | Contact | 15017541801 | 86 | linxq361@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hantong Hu, M.D. | The Third Affiliated hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32104524 | Background | 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. | |
| 37814607 | Derived | 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. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Average pure-tone threshold will be assessed by pure-tone audiometry. |
| at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up |
| 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. | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up |
| 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. | at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |