Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2018-11-01
2019-06-18
Brief Summary
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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.
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Detailed Description
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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.
According to the randomization method, the group to which each participant was assigned was only known to the researcher who applied acupuncture therapy. The participants and the remaining researchers that administered THI to the participants were blinded to the groups.
The data were obtained from the patients' responses to VAS and THI questionnaires. Each participant completed the VAS and THI questionnaires seven times during the course of the five-week treatment and the three-month follow-up after treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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sham acupuncture
Ten acupuncture sessions were applied over five weeks. In this study, acupuncture style is the traditional Chinese model, acupuncture was performed on 11 acupuncture points (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of the affected side, and GB20, TE05, KI3 of both sides) using sterile, single-use, 0.25 mm thick, 40 mm long needles (Dongbang Medical Co., Boryeong, Korea). The acupuncture points were selected by taking previous studies as reference. The depth of the needle differed depending on the anatomical structure of the participant and the nature of the acupuncture points, but it was approximately 5-10 mm. The acupuncture needles were applied until the participant experienced de-qi and removed after 20 minutes.
acupuncture
acupuncture group and control group
acupuncture
en acupuncture sessions were applied over five weeks. In this study, acupuncture style is the traditional Chinese model, acupuncture was performed on 11 acupuncture points (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of the affected side, and GB20, TE05, KI3 of both sides) using sterile, single-use, 0.25 mm thick, 40 mm long needles (Dongbang Medical Co., Boryeong, Korea). The acupuncture points were selected by taking previous studies as reference. The depth of the needle differed depending on the anatomical structure of the participant and the nature of the acupuncture points, but it was approximately 5-10 mm. The acupuncture needles were applied until the participant experienced de-qi and removed after 20 minutes.
acupuncture
acupuncture group and control group
Interventions
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acupuncture
acupuncture group and control group
Other Intervention Names
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Eligibility Criteria
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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.
18 Years
60 Years
ALL
No
Sponsors
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World Health Organization
OTHER
Aksaray University Training and Research Hospital
OTHER
Responsible Party
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ihsan kuzucu
ent
Locations
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Ihsan Kuzucu
Ankara, , Turkey (Türkiye)
Countries
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Related Links
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comparison acupuncture
Other Identifiers
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tinnitusacupuncture
Identifier Type: -
Identifier Source: org_study_id
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