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

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

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: 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 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Changes in tinnitus handicap inventory (THI) compared with baseline	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	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

Outcome Measure	Measure Description	Time Frame
Effective response rate of THI	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	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	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	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)	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	The Zung Self-Rating Depression Scale(SDS) will be adopted.	Baseline, and at weeks 4, 8 ,12 after randomization.
Anxiety	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)	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)		Baseline, and at weeks 4, 8 ,12 after randomization.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroticism Extraversion Openness Five-Factor Inventory, NEO-FFI	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)	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)	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)	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)	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)	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

• 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): April 1, 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): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tinnitus; Usual care; Sham acupuncture; Manual acupuncture
• 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