Tinnitus and Acupuncture

Akasaray University

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Biological: acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ihsan Kuzucu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• The exclusion criteria were having received acupuncture therapy for the last three months for any reason, having a history of medication/surgery due to heart disease, having a disease that could cause objective tinnitus, such as Meniere's disease, otitis media, and otosclerosis, having metal allergy or needle phobia, having a history of psychotropic drug use, pregnancy or nursing, and not completing the THI survey.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sham acupuncture; Ten acupuncture sessions were applied over five weeks. In this study, acupuncture style is the traditional Chinese model, acupuncture was performed on 11 acupuncture points (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of the affected side, and GB20, TE05, KI3 of both sides) using sterile, single-use, 0.25 mm thick, 40 mm long needles (Dongbang Medical Co., Boryeong, Korea). The acupuncture points were selected by taking previous studies as reference. The depth of the needle differed depending on the anatomical structure of the participant and the nature of the acupuncture points, but it was approximately 5-10 mm. The acupuncture needles were applied until the participant experienced de-qi and removed after 20 minutes.	Biological: acupuncture; acupuncture group and control group; Other Names: sham group
Active Comparator: acupuncture; en acupuncture sessions were applied over five weeks. In this study, acupuncture style is the traditional Chinese model, acupuncture was performed on 11 acupuncture points (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of the affected side, and GB20, TE05, KI3 of both sides) using sterile, single-use, 0.25 mm thick, 40 mm long needles (Dongbang Medical Co., Boryeong, Korea). The acupuncture points were selected by taking previous studies as reference. The depth of the needle differed depending on the anatomical structure of the participant and the nature of the acupuncture points, but it was approximately 5-10 mm. The acupuncture needles were applied until the participant experienced de-qi and removed after 20 minutes.	Biological: acupuncture; acupuncture group and control group; Other Names: sham group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
THI	tinnitus handicap index	5 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Visual Analog Scala	5 week

Collaborators and Investigators

• Sponsor: Aksaray University Training and Research Hospital
• Collaborators: World Health Organization

Publications and helpful links

Helpful Links

• comparison acupuncture

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): March 16, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: acupuncture; tinnitus; otology; prospective study
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: tinnitusacupuncture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: A total of 179 subjects with chronic severe subjective tinnitus were initially evaluated. After applying the related criteria, 70 patients (39.1%) were excluded from the study. Of the remaining 109 participants (60.9%), 105 (92%) completed the study. The study group consisted of 53 participants, 19 male and 34 female, with a mean age of 50.70 ± 9.96 years. In the control group, there were 52 participants, 17 male and 35 female, with a mean age of 47.63 ± 11.35 years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No