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NCT07700069

Acupuncture Versus Sham Acupuncture for Tinnitus

Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

Summary

This multicenter, randomized, sham-controlled clinical trial will evaluate the efficacy and safety of acupuncture for patients with subjective idiopathic tinnitus. A total of 226 eligible participants will be randomly assigned to receive either acupuncture or sham acupuncture. Both groups will receive treatment for 5 weeks. The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus loudness, tinnitus severity, sleep quality, anxiety, depression, audiological assessments, and adverse events. Exploratory neuroimaging outcomes include functional magnetic resonance imaging and magnetoencephalography measures.

Official title: Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2026-07-10

Completion Date

2027-03-31

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Tinnitus

Interventions

PROCEDURE

Acupuncture

Standardized acupuncture treatment will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total. Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6). Needles will be inserted according to standardized acupoint locations and retained for 20 minutes. Participants will also receive tinnitus-related health education.

PROCEDURE

Sham Acupuncture

Non-penetrating sham acupuncture will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total. The same acupoints as the acupuncture group will be used. Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation. Needles will be retained for 20 minutes. Participants will also receive tinnitus-related health education.

Inclusion Criteria: 1. Tinnitus as the primary complaint, meeting the diagnostic criteria for subjective idiopathic tinnitus. 2. Tinnitus duration of at least 6 months. 3. Patent external auditory canal and intact tympanic membrane. 4. Bilateral pure tone average no greater than 80 decibels hearing level (dB HL). 5. No contraindications to MRI or MEG scanning, such as claustrophobia or metallic implants. 6. Age 18 to 80 years. 7. Right-handed. 8. Baseline Tinnitus Handicap Inventory score of 38 or higher. 9. Able to understand and complete examinations, assessments, and treatment procedures under physician guidance. 10. Willing to participate and able to provide written informed consent before treatment. Exclusion Criteria: 1. Inner ear or auditory nerve disorders, including sudden sensorineural hearing loss, Meniere disease, otosclerosis, or acoustic neuroma. 2. External or middle ear diseases, including otitis externa, foreign body in the external auditory canal, eczema of the external auditory canal, cerumen impaction, acute or chronic otitis media with effusion, or acute or chronic suppurative otitis media. 3. Non-otogenic tinnitus caused by acute or chronic systemic diseases involving hematologic, endocrine, renal, or other major organ systems. 4. Objective tinnitus, including myogenic, vascular, or patulous eustachian tube-related tinnitus. 5. Cognitive impairment or tinnitus caused by other neurological diseases, including stroke, epilepsy, traumatic brain injury, severe headache history, severe central ischemia, brain tumor, neurasthenia, or post-neurosurgical tinnitus. 6. Severe cardiovascular or cerebrovascular disease, intracranial space-occupying disease, tumor, or severe pulmonary, hepatic, renal, or hematopoietic disease. 7. Pregnancy or lactation. 8. Psychiatric disease, impaired consciousness, or inability to cooperate with examinations or treatment. 9. Participation in another conflicting clinical trial within 6 months before enrollment or currently participating in another conflicting clinical trial.

Locations (3)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Clinical Research Directory

Acupuncture Versus Sham Acupuncture for Tinnitus

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (3)