Tinnitus, Subjective Clinical Trial
Official title:
Akasaray University
Verified date | October 2019 |
Source | Aksaray University Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: This study aimed to investigate the effect, onset and duration of action, and
short-term outcomes of acupuncture therapy in the treatment of patients with severe chronic
subjective tinnitus.
Methods: This study is a randomized, controlled trial evaluating patients with chronic,
idiopathic and severe tinnitus. A total of 105 participants were divided into two groups
using the randomization method: the study group that received real acupuncture therapy (n =
53) and the sham acupuncture group. Ten acupuncture sessions were applied over five weeks.
After treatment, each participant was monitored for up to three months according to the
changes in the Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI), Pure-Tone
Audiometry and Speech Discrimination scores.
Status | Completed |
Enrollment | 105 |
Est. completion date | June 18, 2019 |
Est. primary completion date | March 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - The inclusion criteria of the study for patients were determined as; (a) male and female patients aged 18 to 60 years, (b) unilateral or bilateral subjective tinnitus, (c) with a history of severe subjective tinnitus for at least one year, (d) patients with severe tinnitus according to the THI questionnaire result (over 38 points), (e) the patients who could not detect etiology of tinnitus in the otolaryngology examination, (f) not having received any treatment within the last six months. The patients who applied to the otorhinolaryngology clinic of our hospital were included in the study Exclusion Criteria: - The exclusion criteria were having received acupuncture therapy for the last three months for any reason, having a history of medication/surgery due to heart disease, having a disease that could cause objective tinnitus, such as Meniere's disease, otitis media, and otosclerosis, having metal allergy or needle phobia, having a history of psychotropic drug use, pregnancy or nursing, and not completing the THI survey. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ihsan Kuzucu | Ankara |
Lead Sponsor | Collaborator |
---|---|
Aksaray University Training and Research Hospital | World Health Organization |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | THI | tinnitus handicap index | 5 week | |
Secondary | VAS | Visual Analog Scala | 5 week |
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