Manual Acupuncture for Acute Primary Tinnitus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tinnitus
• Intervention / Treatment: Behavioral: Usaual care; Other: Manual acupuncture; Other: Sham acupuncture

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Bing, PhD; Phone Number: 86+13971058388; Email: didibing1981@aliyun.com
• Study Contact Backup: Name: Dan Bing, PhD; Phone Number: 86-13971058388; Email: didibing1981@aliyun.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-65 years, male or female;
2. Primary complaint is persistent tinnitus (unilateral or bilateral);
3. 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);
4. Had continuous tinnitus ≥2 weeks and <6 months;
5. Tinnitus should be bothersome, with a screening THI score 28-76;
6. Acupuncture naive;
7. Able to provide written informed consent.

Exclusion Criteria:

1. Objective tinnitus;
2. Pulsatile tinnitus;
3. Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases);
4. Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram);
5. Had contraindications for acupuncture, including curent pregnant, severe anemia, coagulation disorders, etc;
6. Having difficulties in expressing their symptoms clearly( 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. 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;
9. Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy;
10. have a strong desire for medication treatment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual acupuncture group; Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.	Behavioral: Usaual care; Health education and standard evaluation related to tinnitus; Other: Manual acupuncture; 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 Comparator: Sham acupuncture; Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks.	Behavioral: Usaual care; Health education and standard evaluation related to tinnitus; Other: Sham acupuncture; 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.
Other: Usual care; 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

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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".	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.	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.	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.	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).	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.	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.	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.	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.	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.	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.	Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-item short version of the Big Five Inventory (BFI-10)	Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10).	Baseline visit(before randomization)
Pure-Tone Audiometry(PTA)	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.	Baseline visit(before randomization)

Collaborators and Investigators

• Sponsor: Dan Bing
• Collaborators: Taihe Hospital; Wuhan No.1 Hospital; The Third People's Hospital of Hubei Province; Hubei Xinhua Hospital; Qianjiang Central Hospital
• Investigators: Principal Investigator: Dan Bing, PhD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 12, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; Tinnitus
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus
• Other Study ID 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