Tinnitus and Acupuncture
Akasaray University
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2019
CompletedFirst Submitted
Initial submission to the registry
September 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedOctober 15, 2019
October 1, 2019
5 months
September 21, 2019
October 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
THI
tinnitus handicap index
5 week
Secondary Outcomes (1)
VAS
5 week
Study Arms (2)
sham acupuncture
PLACEBO COMPARATORTen 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
ACTIVE COMPARATORen 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.
Interventions
acupuncture group and control group
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ihsan Kuzucu
Ankara, 06100, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ent
Study Record Dates
First Submitted
September 21, 2019
First Posted
October 15, 2019
Study Start
November 1, 2018
Primary Completion
March 16, 2019
Study Completion
June 18, 2019
Last Updated
October 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
A total of 179 subjects with chronic severe subjective tinnitus were initially evaluated. After applying the related criteria, 70 patients (39.1%) were excluded from the study. Of the remaining 109 participants (60.9%), 105 (92%) completed the study. The study group consisted of 53 participants, 19 male and 34 female, with a mean age of 50.70 ± 9.96 years. In the control group, there were 52 participants, 17 male and 35 female, with a mean age of 47.63 ± 11.35 years.