NCT07515482

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

Manual Acupuncture on Acute Primary Tinnitus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Dan Bing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
OTHER	Manual acupuncture	After sterilisation, the fine needles will be inserted into the deep tissue layers of all acupoints and will be retained for 30 min. Acupuncturists will tried to elicit acupuncture de-qi sensation with light lifting, thrusting, and twirling every 10min during each session.
OTHER	Sham acupuncture	After sterilisation, Streitberger placebo needles with blunt tip will be used. It can be fixed on the surface of the sham points without piercing the skin. Within a 30-minute period, each point will undergo a simulated twisting motion of the needle for at least 10 seconds, and this will be repeated four times at 10-minute intervals.
BEHAVIORAL	Usaual care	Health education and standard evaluation related to tinnitus

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-30
• Completion: 2027-12-12
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China