Subjective tinnitus Ear, Nose and Throat Tinnitus
Conditions
Interventions
This study is a randomized, single-blind, controlled study. Participants will receive acupuncture at local points in combination with distal points for 4 weeks.
Time points are as follows:
Visit 1: s
Sponsors
Beijing Municipal Health Bureau (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of subjective tinnitus, unilateral or bilateral 2. Age 18-65 years, either sex 3. Tinnitus duration of at least 3 months 4. Agreed not to receive another treatment during the clinical trial period 5. Written and informed consent
Exclusion criteria
Exclusion criteria: 1. Objective tinnitus 2. Underlying disease or history: 2.1. Otitis media 2.2. Acoustic tumour 2.3. Intracranial lesion 2.4. Inner ear malformation 2.5. Head trauma 2.6. Ototoxic drug medication 3. Women in pregnacy and lactation or without contraception 4. History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder, blood transfusion affecting the brain or prior brain surgery 5. Inability to correct use of test equipment: unable to cooperate during audiologic examination 6. Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective tinnitus loudness and annoyance perception was graded using the Visual Analogue Scale (VAS). The assessment was at baseline (before treatment initiation), 4 weeks after the first acupuncture and 8 weeks after the first acupuncture. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of tinnitus severity according to the tinnitus questionnaire of the Tinnitus Handicap Inventory (THI): 1.1. F: Functional subscale (11 factors) 1.2. E: Emotional subscale (9 factors) 1.3. C: Catastrophic subscale (5 factors) Each question of the THI can be answered by the patient with either often (2 points), sometimes (1 point) or never (0 points), with a maximum total score of 100 indicating most severe suffering from tinnitus. The assessment was at baseline (before treatment initiation), 4 weeks after the first acupuncture and 8 weeks after the first acupuncture. 2. Changes of tone and noise parameters of tinnitus, assessed by tinnitus matching (screening versus week 8) at 4 and 8 weeks after the first acupuncture, follow up. 3. Perceived Credibility of acupuncture was evaluated by The Treatment Credibility Scale (TCS) after a 4-week acupuncture session. It is a 5-item questionnaire ranging from 1 (not at all) to 5 (very confident); items were averaged to provide a single treatment credibility score, with high scores reflecting high treatment credibility. 4. To evaluate the adequacy of blinding, we asked participants to rate how certain they were that they had received traditional acupuncture or a new method of acupuncture on a 7-point scale (1 very sure, 7 very uncertain) after 4 weeks of treatment. Participants also reported adverse events they experienced, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each treatment. | — |
Countries
China
Outcome results
None listed