This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
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.
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.
Health education and standard evaluation related to tinnitus
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, China
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.
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)
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
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.
Time frame: 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.
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
We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess 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.
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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".
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)
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.
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)
The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.
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)
The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.
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)
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).
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)
Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.