Manual Acupuncture for Acute Primary Tinnitus

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.

25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.

Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points.

Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points.

We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.

The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".

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.

The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.

The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.

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).

Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship.

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.

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.

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.

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.

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.

Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10).

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.