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

March 31, 2026 updated by: Dan Bing

Manual Acupuncture on Acute Primary Tinnitus

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 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.

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 (Estimated)

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.
180

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Triple

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.
Experimental: Manual acupuncture group
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.
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.
Behavioral: Usaual care
Health education and standard evaluation related to tinnitus
Sham Comparator: Sham acupuncture group
All patients will receive 10 sessions of 30 minute sham acupuncture treatment over a four-week treatment period.
Behavioral: Usaual care
Health education and standard evaluation related to tinnitus
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.
Other: Usual care group
Health education and guidance related to tinnitus
Behavioral: Usaual care
Health education and standard evaluation related to tinnitus

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
Changes in tinnitus handicap inventory (THI) compared with baseline
Time Frame: During the baseline period, and 2,4,6,8,10,12 weeks after randomization.
The THI scale covering 25 questions in three dimensions: function, emotion, and severity.
During the baseline period, and 2,4,6,8,10,12 weeks after randomization.
Changes in tinnitus functional index (TFI) compared with baseline
Time Frame: During the baseline period, and 2,4,6,8,10,12 weeks after randomization.
The TFI scale was used to comprehensively assess the impact of tinnitus on the multi-dimensional and various functions of patients' daily lives
During the baseline period, and 2,4,6,8,10,12 weeks after randomization.

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
Effective response rate of THI
Time Frame: 2,4,6,8,10,12 weeks after randomization.
The proportion of patients with a THI score decrease of ≥7 points.
2,4,6,8,10,12 weeks after randomization.
Effective response rate of TFI
Time Frame: 2,4,6,8,10,12 weeks after randomization.
The proportion of patients with a TFI score decrease of ≥13 points.
2,4,6,8,10,12 weeks after randomization.
Visual Analogue Scale (VAS) for aural fullness
Time Frame: Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization.
We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.
Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization.
Visual Analogue Scale (VAS) for tinnitus
Time Frame: Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization.
The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".
Baseline, and at weeks 2, 4, 6, 8 ,10 and 12 after randomization.
Pittsburgh sleep quality index (PSQI)
Time Frame: Baseline, and at weeks 4, 8 ,12 after randomization.
PSQI is a self-rated questionnaire which evaluate sleep quality and disturbances over a 1-month time interval.
Baseline, and at weeks 4, 8 ,12 after randomization.
Depression
Time Frame: Baseline, and at weeks 4, 8 ,12 after randomization.
The Zung Self-Rating Depression Scale(SDS) will be adopted.
Baseline, and at weeks 4, 8 ,12 after randomization.
Anxiety
Time Frame: Baseline, and at weeks 4, 8 ,12 after randomization.
The Zung Self-Rating Anxiety Scale(SAS) will be adopted
Baseline, and at weeks 4, 8 ,12 after randomization.
Short Form-36 Health Survey (SF-36)
Time Frame: Baseline, and at weeks 4, 8 ,12 after randomization.
The SF-36 consists of 36 items and is used to assess eight health areas: physiological function, body role, somatic pain, overall health, vitality, social function, emotional role and mental health
Baseline, and at weeks 4, 8 ,12 after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9)
Time Frame: Baseline, and at weeks 4, 8 ,12 after randomization.
Baseline, and at weeks 4, 8 ,12 after randomization.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuroticism Extraversion Openness Five-Factor Inventory, NEO-FFI
Time Frame: Baseline
Based on the Big Five Personality Scale developed by Costa et al., it has been revised, including five dimensions and 60 items. Each dimension is scored separately.
Baseline
Pure-Tone Audiometry(PTA)
Time Frame: At baseline period (before randomization)
Pure tone audiometry is conducted under standard soundproof conditions using the Hughson-Westlake method to obtain the air conduction threshold (bone conduction threshold is only used for diagnosis, to determine whether there is conductive hearing loss, and to assist in the screening process; statistical analysis only uses the air conduction threshold). The standard test frequencies range from 0.25 to 8 kHz. If conditions permit, extended high frequencies (Extended High Frequency, EHF; ≥ 9-16 kHz) are added, and necessary masking is performed in accordance with the norms.
At baseline period (before randomization)
Tinnitus Pitch Matching (TPM)
Time Frame: At baseline period (before randomization)
TPM is used for classification and stratification of tinnitus phenotypes (pitch position, type, and correlation with hearing loss), as well as for description of baseline characteristics. When necessary, it is also used for collaborative analysis with extended high frequencies, hearing configurations, etc.
At baseline period (before randomization)
Tinnitus Loudness Matching (TLM)
Time Frame: At baseline period (before randomization)
Using the determined pitch-matched frequency as the stimulus, gradually increase the sound level from 5 dB SL above the threshold until the subject considers it to be equivalent to their subjective tinnitus loudness; for wide-band noise type tinnitus, narrow-band noise can be used for matching instead.
At baseline period (before randomization)
Acoustic Reflex Threshold (ART)
Time Frame: At baseline period (before randomization)
ART is mainly used for baseline characteristics and stratification (such as middle ear status screening, sensorineural and third neuron/facial nerve pathway associations, and correlations with hearing threshold/aural noise phenotype), and also assists in inclusion and exclusion criteria (such as universal absence due to obstruction)
At baseline period (before randomization)
Otoacoustic Emissions (OAE)
Time Frame: At baseline period (before randomization)
ART is mainly used for baseline characteristics and stratification (such as middle ear status screening, sensorineural and third neuron/facial nerve pathway associations, and correlations with hearing threshold/aural noise phenotype), and also assists in inclusion and exclusion criteria (such as universal absence due to obstruction)
At baseline period (before randomization)

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.
Dan Bing

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.
Taihe Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Hubei Xinhua Hospital
Qianjiang Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dan Bing, PhD, Tongji Hospital

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 (Estimated)

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.
April 1, 2026

Primary Completion (Estimated)

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.
October 30, 2027

Study Completion (Estimated)

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.
December 12, 2027

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).
March 31, 2026

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.
March 31, 2026

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.
April 7, 2026

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.
April 7, 2026

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.
March 31, 2026

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.
March 1, 2026

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.
  • Tinnitus(2025-TJ-MA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD after de-identification can be shared on individual request to the principal investigator at didibing1981@aliyun.com

IPD Sharing Time Frame

IPD and supporting information will be available within 2 years after publication of the results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

Clinical Trials on Tinnitus

Clinical Trials on Manual acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings