Manual Acupuncture for Acute Primary Tinnitus

Official title

Manual Acupuncture Versus Sham Acupuncture and Usual Care for Acute Primary Tinnitus: Multicentre, Randomized Clinical Trial

Overview

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.

Interventions

• 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.
• 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.
• Behavioral Usaual care
  Health education and standard evaluation related to tinnitus

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (12)

• 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,.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Wuhan

Identifiers

NCT: NCT07515482 · Tinnitus(2025-TJ-MA)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗