Manual Acupuncture for Acute Primary Tinnitus

NCT07515482 | Not Yet Recruiting DMC

• 1 other identifier: Tinnitus(2025-TJ-MA)
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.

Conditions

Tinnitus

Keywords

Tinnitus; acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Effective response rate of THI

  End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.

• Effective response rate of TFI.

  End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.

• Visual Analogue Scale (VAS) for 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

  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)

  Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Other Outcomes (2)

• 10-item short version of the Big Five Inventory (BFI-10)

  Baseline visit(before randomization)

• Pure-Tone Audiometry(PTA)

  Baseline visit(before randomization)

Study Arms (3)

Manual acupuncture group

EXPERIMENTAL

Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.

Other: Manual acupuncture; Behavioral: Usaual care

Sham acupuncture

SHAM COMPARATOR

Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks.

Other: Sham acupuncture; Behavioral: Usaual care

Usual care

OTHER

Health education and guidance related to tinnitus

Behavioral: Usaual care

Interventions

Manual acupuncture OTHER

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.

Manual acupuncture group

Sham acupuncture OTHER

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.

Sham acupuncture

Usaual care BEHAVIORAL

Health education and standard evaluation related to tinnitus

Manual acupuncture group; Sham acupuncture; Usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Dan Bing: lead
• Hubei Xinhua Hospital: collaborator
• Wuhan No.1 Hospital: collaborator
• The Third People's Hospital of Hubei Province: collaborator
• Taihe Hospital: collaborator
• Qianjiang Central Hospital: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dan Bing, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Bing, PhD

CONTACT

86+13971058388; didibing1981@aliyun.com

Dan Bing, PhD

CONTACT

86-13971058388; didibing1981@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to intervention condition (manual avupuncture or sham acupuncture). Outcome assessors and data analysts are blinded to group allocation. Given the nature of acupuncture manipulation, acupuncturists in this trial are not blinded. However, acupuncturists does not take part in outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are assigned 1:1:1 to three parallel arms.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available within 2 years after publication of the results.

Locations

CN (1)