Clinical trial NCT04127708: Tinnitus and Acupuncture
Official title: Akasaray University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: tinnitus
acupuncture
otology
prospective study
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2019-10-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This was a prospective, randomized, controlled study, approved by the local ethics committee and carried out in a single center in accordance with the ethical principles of the Helsinki Declaration (E-18-2165).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: THI
timeFrame: 5 week
Secondary outcomes:
measure: VAS
timeFrame: 5 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ihsan Kuzucu
Study officials:
References: