NCT04127708

Tinnitus and Acupuncture

Akasaray University

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Aksaray University Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Objective: This study aimed to investigate the effect, onset and duration of action, and short-term outcomes of acupuncture therapy in the treatment of patients with severe chronic subjective tinnitus. Methods: This study is a randomized, controlled trial evaluating patients with chronic, idiopathic and severe tinnitus. A total of 105 participants were divided into two groups using the randomization method: the study group that received real acupuncture therapy (n = 53) and the sham acupuncture group. Ten acupuncture sessions were applied over five weeks. After treatment, each participant was monitored for up to three months according to the changes in the Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Pure-Tone Audiometry and Speech Discrimination scores.

Detailed description

This was a prospective, randomized, controlled study, approved by the local ethics committee and carried out in a single center in accordance with the ethical principles of the Helsinki Declaration (E-18-2165). The inclusion criteria of the study for patients were determined as; (a) male and female patients aged 18 to 60 years, (b) unilateral or bilateral subjective tinnitus, (c) with a history of severe subjective tinnitus for at least one year, (d) patients with severe tinnitus according to the THI questionnaire result (over 38 points), (e) the patients who could not detect etiology of tinnitus in the otolaryngology examination, (f) not having received any treatment within the last six months. The patients who applied to the otorhinolaryngology clinic of our hospital were included in the study. According to the randomization method, the group to which each participant was assigned was only known to the researcher who applied acupuncture therapy. The participants and the remaining researchers that administered THI to the participants were blinded to the groups. The data were obtained from the patients' responses to VAS and THI questionnaires. Each participant completed the VAS and THI questionnaires seven times during the course of the five-week treatment and the three-month follow-up after treatment.

Conditions

• Tinnitus, Subjective

Interventions

Type	Name	Description
BIOLOGICAL	acupuncture	acupuncture group and control group

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-03-16
• Completion: 2019-06-18
• First posted: 2019-10-15
• Last updated: 2019-10-15

Locations

1 site across 1 country: Turkey (Türkiye)