TinnitusNCT07515482
Manual Acupuncture for Acute Primary Tinnitus
A study testing Manual acupuncture and Usaual care in people with Tinnitus, run by Dan Bing at 1 site in China.
Trial summary
This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Manual acupuncture and Usaual care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 12 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, male or female;
- Primary complaint is persistent tinnitus (unilateral or bilateral);
- Meet the diagnostic criteria for primary tinnitus according to the 2014 Clinical Practice Guideline developed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF);
- Had continuous tinnitus ≥2 weeks and <6 months;
- Tinnitus should be bothersome, with a screening THI score 28-76;
- Acupuncture naive;
- Able to provide written informed consent.
Who cannot join
- Objective tinnitus;
- Pulsatile tinnitus;
- Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases);
- Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram);
- Had contraindications for acupuncture, including curent pregnant, severe anemia, coagulation disorders, etc;
- Having difficulties in expressing their symptoms clearly( severe mental disorders or cognitive impairment);
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- Currently suffering from other serious acute or chronic organic diseases, such as cerebrovascular, cardiovascular, liver, kidney, hematological diseases, infectious diseases, or malignant tumors;
- Has received intratympanic injection, postauricular injection, corticosteroids, or other medications for tinnitus treatment (includingTraditional Chinese Medicine or proprietary Chinese medicines) within the past 2 weeks or at baseline;
- Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy;
- have a strong desire for medication treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, 430030
About this study
Official title: Manual Acupuncture Versus Sham Acupuncture and Usual Care for Acute Primary Tinnitus: Multicentre, Randomized Clinical Trial
This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
Read the detailed description
This is a multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment and statistician. The total trial period will be 14 weeks, including two weeks of baseline assessment, four weeks of treatment, and eight weeks of follow-up. A total of 180 patients with acute primary tinnitus will be randomized in a 1:1:1 ratio to receive 10 sessions of manual acupuncture, 10 sessions of sham acupuncture, or usual care alone over 4 weeks. Informed consent will be obtained from each patient before randomization.
- Conditions
- Tinnitus
- Being tested
- Manual acupuncture, Sham acupuncture, Usaual care
- Keywords
- Tinnitus, acupuncture
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupunctureOther
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks.
Sham acupunctureOther
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks.
Usaual careBehavioural
Health education and standard evaluation related to tinnitus
| Study group | Role | What they receive |
|---|---|---|
| Manual acupuncture group | Experimental | Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period. Receives: Other: Manual acupuncture; Behavioral: Usaual care |
| Sham acupuncture | Sham comparator | Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks. Receives: Other: Sham acupuncture; Behavioral: Usaual care |
| Usual care | Other | Health education and guidance related to tinnitus Receives: Behavioral: Usaual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI, 0-100)
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and >76 points indicate catastrophic handicap.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Tinnitus Functional Index (TFI, 0-100)
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Secondary outcomes (14)
Effective response rate of THI
Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points.
Measured: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI.
Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points.
Measured: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for aural fullness
We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for tinnitus
The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Pittsburgh Sleep Quality Index (PSQI)
The pittsburgh Sleep Qual-ityIndex (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has 19 questions which can be grouped into seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep dis-turbances, use of sleeping medication, and daytime dysfunction.The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS)
The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS)
The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF)
Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), yielding domain scores and an overall score (0-100; higher scores indicate better quality of life).
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9)
Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Adverse Events
Adverse events assessed each acupuncture treatment visit using a acupuncture adverse events questionnaire recording presence and severity of side effects (e.g., subcutaneous hemorrhage, minor bleeding) related to acupuncture, plus event frequency.
Measured: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Assessment of blinding
At the end of the study, we will determine the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin.
Measured: At 12 weeks after randomization
Acupuncture expectancy scale(AES)
The Acupuncture Expectancy Scale (AES) will be completed by participants in the verum and sham acupuncture groups at baseline and at the end of treatment (4 weeks after randomization). The questionnaire will not be administered to the usual care group.
Measured: Baseline visit, and end of treatment at 4 weeks after randomization,.
Massachusetts General Hospital Acupuncture Sensation Scale(MASS)
The Massachusetts General Hospital Acupuncture Sensation Scale, which includes twelve specific descriptors-soreness, aching, deep pressure, heaviness, fullness or distension, tingling, numbness, sharp pain, dull pain, warmth, cold, and throbbing-as well as an open field for patients to describe the sensation in their own words, will be administered following a brief explanation of de qi sensations by the acupuncturist to participants in the verum acupuncture and sham acupuncture groups, while the usual care group will not receive this questionnaire.
Measured: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Auditory Sensitivity Scale
Auditory Sensitivity Scale is a self-report questionnaire consisting of general questions on tinnitus and sound intolerance, along with 25 items rated on different scoring scales (e.g., 0/2/5, 0/1/2, 0/10), and provides a severity classification based on the total score: 31-55 for mild, 56-80 for moderate, 81-100 for severe, and 101-126 for very severe.
Measured: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned 1:1:1 to three parallel arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Bing
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Xinhua Hospital, Wuhan No.1 Hospital, The Third People's Hospital of Hubei Province, Taihe Hospital, Qianjiang Central Hospital
- Responsible party
- Sponsor-investigator, Dan Bing, Tongji Hospital
- Investigators
- Dan Bing, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515482
- Sponsor's protocol ID
- Tinnitus(2025-TJ-MA)
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD after de-identification can be shared on individual request to the principal investigator at didibing1981@aliyun.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Acupuncture Versus Sham Acupuncture and Usual Care for Acute Primary Tinnitus: Multicentre, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07515482
- Acronym / sponsor ID
- Tinnitus(2025-TJ-MA)
- Conditions
- Tinnitus
- Keywords
- Tinnitus, acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dan BingUniversity, hospital or other
- Collaborators
- Hubei Xinhua Hospital, Wuhan No.1 Hospital, The Third People's Hospital of Hubei Province, Taihe Hospital, Qianjiang Central Hospital
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
Detailed description
This is a multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment and statistician. The total trial period will be 14 weeks, including two weeks of baseline assessment, four weeks of treatment, and eight weeks of follow-up. A total of 180 patients with acute primary tinnitus will be randomized in a 1:1:1 ratio to receive 10 sessions of manual acupuncture, 10 sessions of sham acupuncture, or usual care alone over 4 weeks. Informed consent will be obtained from each patient before randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are assigned 1:1:1 to three parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Manual acupuncture group | Experimental | Other: Manual acupuncture, Behavioral: Usaual careTen sessions of 30 minute manual acupuncture are deivered during a four-week treatment period. |
| Sham acupuncture | Sham comparator | Other: Sham acupuncture, Behavioral: Usaual careTen sessions of 30 minute sham acupuncture are deivered during 4 weeks. |
| Usual care | Other | Behavioral: Usaual careHealth education and guidance related to tinnitus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65 years, male or female;
- Primary complaint is persistent tinnitus (unilateral or bilateral);
- Meet the diagnostic criteria for primary tinnitus according to the 2014 Clinical Practice Guideline developed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF);
- Had continuous tinnitus ≥2 weeks and <6 months;
- Tinnitus should be bothersome, with a screening THI score 28-76;
Key exclusion criteria (10 listed)
- Objective tinnitus;
- Pulsatile tinnitus;
- Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases);
- Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram);
- Had contraindications for acupuncture, including curent pregnant, severe anemia, coagulation disorders, etc;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual acupunctureTen manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks. | Other | Manual acupuncture group |
| Sham acupunctureTen manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks. | Other | Sham acupuncture |
| Usaual careHealth education and standard evaluation related to tinnitus | Behavioural | Manual acupuncture group, Sham acupuncture, Usual care |
Primary outcome
Tinnitus Handicap Inventory (THI, 0-100)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and >76 points indicate catastrophic handicap.
Tinnitus Functional Index (TFI, 0-100)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
14 secondary outcomes
Effective response rate of THI
Time frame: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI.
Time frame: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for aural fullness
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for tinnitus
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9)
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Adverse Events
Time frame: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Assessment of blinding
Time frame: At 12 weeks after randomization
Acupuncture expectancy scale(AES)
Time frame: Baseline visit, and end of treatment at 4 weeks after randomization,.
Massachusetts General Hospital Acupuncture Sensation Scale(MASS)
Time frame: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Auditory Sensitivity Scale
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. IPD after de-identification can be shared on individual request to the principal investigator at didibing1981@aliyun.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Bing, PhD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture and Usaual care in people with Tinnitus, run by Dan Bing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Bing, PhD (86+13971058388, didibing1981@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI, 0-100) (time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.