The Effect of Acupuncture on Patients With Noise-induced Hearing Loss

Electroacupuncture Clinical Trial

Official title:

The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05511753
• Other study ID #: CMUH110-REC1-240
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2022
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Electroacupuncture
• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise Induced Hearing Loss

Intervention

Device:
• electroacupuncture
Insert stainless steel needles into the above acupoints and twist the needles to get qi. In addition, electroacupuncture stimulation (intensity 1mA, frequency 2Hz) was applied to connect the ipsilateral Yifeng and Wangu, and the ipsilateral Zhongzhu and Quchi.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pure tone audiometry observe changes in hearing	The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.	Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment