The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
| Registry | NCT05511753 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | China Medical University Hospital (Other) |
| Conditions | Electroacupuncture, Noise Induced Hearing Loss, Hearing Loss, Noise-Induced |
| Interventions | electroacupuncture (Device) |
| Dates | start 2022-09-01 (estimated), primary completion 2023-07-30 (estimated), completion 2023-09-01 (estimated), first posted 2022-08-23, last updated 2022-08-23 |
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In an era of advanced industry and commerce, working in a noisy environment is one of the most important risk factors for hearing damage, especially among young and middle-aged people. Although acupuncture has been widely used to treat otology-related diseases, such as tinnitus, dizziness, and sudden deafness, there are few studies on the effect of noise-induced hearing loss.
Therefore, the purpose of this study is to investigate the effect of acupuncture on patients with noise-induced hearing loss. This study is designed as a randomized, single-blind, control prospective clinical trial. Eighty subjects with noise-induced hearing loss were included in the criteria and randomly divided into the acupuncture group and the control group as follows: 1) In the acupuncture group, in addition to the conventional treatment, acupuncture on both sides of Baihui (GV20), Dazhui (GV14), Yifeng (TE17), Wangu (GB12), Zhongzhu (TE3), Quchi (LI11), and connecting Yifeng and Wangu, and Zhongzhu and Quchi are given electroacupuncture stimulation (intensity of 1mA, frequency of 2Hz), 3 times a week, 15 minutes each time, continuous 6 weeks; 2) The control group was given conventional treatment only. The main assessment is the hearing changes of the pure tone hearing test, which measure the hearing thresholds of 2KHz, 4KHz, and 8KHz respectively; the secondary assessment is the change of the tinnitus handicap index score. The evaluation time includes before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after the end of acupuncture treatment.
The results of this study are expected to prove that acupuncture can improve noise-induced hearing loss.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| pure tone audiometry improving | Experimental | Device: electroacupuncture | Pure tone audiometry: observe changes in hearing ability Evaluation time: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment, pure-tone audiometry was performed. The pure tone audiometry measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively. |
Sex: All, ages: 20 Years to 65 Years
Inclusion Criteria: * pure tone audiometry diagnosed noise-induced hearing loss * age: 20 - 65 Exclusion Criteria: * major medical disease -- cancer, renal disease * pregnancy or milk women * anti-coagulation use * pacemaker use * allergy to needle * denied accept inform consent