Effect of Manual Acupuncture on Acute Primary Tinnitus: A Multicenter Randomized Controlled Clinical Trial

Dan Bing

Status: Not yet enrolling

Conditions: Tinnitus

Treatments: Other: Sham acupuncture; Behavioral: Usaual care; Other: Manual acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07515482

Tinnitus(2025-TJ-MA)

Details and patient eligibility

About

This multicenter clinical trial aims to investigate the efficacy and safety of manual acupuncture on acute primary tinnitus.

Full description

This is a multicenter randomized, single-blind, sham-controlled trial. The total trial period was 14 weeks, including two weeks of baseline assessment, four weeks of treatment after randomisation, and eight weeks of follow-up. Informed consent will be obtained from each patient before randomisation. After the baseline assessment, an independent investigator will randomise eligible patients in a 1:1:1 ratio to receive manual acupuncture, sham acupuncture, or usual care. All patients will receive 10 sessions of 30 minute acupuncture treatments or usual care over a four-week treatment period. They will be treated three times a week to fulfil a two-week of initial treatment course and then will be treated twice a week to fulfil a two-week of consolidation treatment course. In both the manual and sham acupuncture group, acupuncture treatment will begin after randomisation. In the usual care group, patients will receive acupuncture for free after waiting 12 weeks.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 65 years (either sex）;
2. The primary complaint is tinnitus;
3. Fulfilled diagnostic criteria for primary tinnitus;
4. Tinnitus should be bothersome, with a THI score ranging from 28 to 76, and lasting for ≥2 weeks;
5. Duration of tinnitus less than 6 months;
6. No acupuncture experience in the past 3 months;
7. No use of medication for tinnitus within 2 weeks before treatment, including intratympanic injections, postauricular injections, corticosteroids, Traditional Chinese Medicine (TCM) or proprietary Chinese medicines and so on;
8. Agree to sign the informed consent form.

Exclusion criteria

1. Objective tinnitus;
2. Pulsatile tinnitus;
3. Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians;
4. Combined conductive hearing loss (confirmed by abnormal otoscopy or abnormal tympanogram);
5. Had contraindications for acupuncture, including pregnant women, severe anemia, coagulation disorders, etc;
6. Having difficulties in expressing their symptoms clearly such as severe mental disorders or cognitive impairment;
7. Currently suffering from other serious acute or chronic organic diseases, such as cerebrovascular, cardiovascular, liver, kidney, hematological diseases, infectious diseases, or malignant tumors;
8. Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy;
9. have a strong desire for medication treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups

Manual acupuncture group

Experimental group

Description:

All patients will receive 10 sessions of 30 minute manual acupuncture treatment over a four-week treatment period. They will be treated three times a week to fulfil a two-week of initial treatment course and then will be treated twice a week to fulfil a two-week of consolidation treatment course.

Treatment:

Other: Manual acupuncture

Behavioral: Usaual care

Sham acupuncture group

Sham Comparator group

Description:

All patients will receive 10 sessions of 30 minute sham acupuncture treatment over a four-week treatment period.

Treatment:

Behavioral: Usaual care

Other: Sham acupuncture

Usual care group

Other group

Description:

Health education and guidance related to tinnitus

Treatment:

Behavioral: Usaual care