Tinnitus and Acupuncture

October 14, 2019 updated by: ihsan kuzucu, Aksaray University Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ihsan Kuzucu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
THI
Time Frame: 5 week
tinnitus handicap index
5 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 5 week
Visual Analog Scala
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aksaray University Training and Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Health Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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