Acupuncture Versus Sham Acupuncture for Tinnitus
Efficacy and Safety of Acupuncture Versus Sham Acupuncture in the Treatment of Tinnitus: A Randomized Controlled Clinical Trial
This multicenter, randomized, sham-controlled clinical trial will evaluate the efficacy and safety of acupuncture for patients with subjective idiopathic tinnitus.
A total of 226 eligible participants will be randomly assigned to receive either acupuncture or sham acupuncture.
Both groups will receive treatment for 5 weeks.
The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus loudness, tinnitus severity, sleep quality, anxiety, depression, audiological assessments, and adverse events.
Exploratory neuroimaging outcomes include functional magnetic resonance imaging and magnetoencephalography measures.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Subjective idiopathic tinnitus is a common otologic condition that may be associated with sleep disturbance, anxiety, depression, and reduced quality of life. Current treatment options often provide limited symptom relief, and high-quality evidence for acupuncture in tinnitus remains insufficient.
This study is designed as a multicenter, randomized, sham-controlled clinical trial to compare acupuncture with non-penetrating sham acupuncture in patients with chronic subjective idiopathic tinnitus. Eligible participants will be adults aged 18 to 80 years with tinnitus as the primary complaint, tinnitus duration of at least 6 months, and a baseline Tinnitus Handicap Inventory score of 38 or higher.
Participants will be randomly assigned in a 1:1 ratio to the acupuncture group or the sham acupuncture group. The acupuncture group will receive standardized acupuncture treatment based on the therapeutic principle of invigorating the spleen, tonifying the kidney, and opening the orifices. The sham acupuncture group will receive non-penetrating sham acupuncture at the same acupoints. Both groups will receive treatment for 5 weeks and tinnitus-related health education.
Participants will be assessed at baseline, during treatment, at the end of treatment, and during post-treatment follow-up. The primary endpoint is the change in Tinnitus Handicap Inventory score from baseline to Week 5. Secondary outcomes include tinnitus-related visual analog scale scores, Pittsburgh Sleep Quality Index, Self-Rating Anxiety Scale, Self-Rating Depression Scale, pure tone audiometry, tinnitus matching, distortion product otoacoustic emissions, and adverse events. Exploratory outcomes include changes in brain functional connectivity measured by functional magnetic resonance imaging and brain power spectral density measured by magnetoencephalography.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
226
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Yun Li, MD
- 전화번호: 0086-021-63138341
- 이메일: liyuncmm@126.com
연구 장소
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200437
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
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연락하다:
- Ling J Zhang, PHD
- 전화번호: 0086-021-65161782
- 이메일: eternityz@sina.com
-
수석 연구원:
- Ying J Tan, MD
-
Shanghai, Shanghai Municipality, 중국, 200011
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
-
연락하다:
- Yun Li, MD
- 전화번호: 0086-021-021-63138341
- 이메일: liyuncmm@126.com
-
수석 연구원:
- Yu G Liu, PHD
-
Shanghai, Shanghai Municipality, 중국, 200032
- Longhua Hospital, Shanghai University of Traditional Chinese Medicine
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연락하다:
- Hui J Lan, MD
- 전화번호: 0086-021-64385700
- 이메일: lanjh_ent@163.com
-
수석 연구원:
- Hui J Lan, MD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Tinnitus as the primary complaint, meeting the diagnostic criteria for subjective idiopathic tinnitus.
- Tinnitus duration of at least 6 months.
- Patent external auditory canal and intact tympanic membrane.
- Bilateral pure tone average no greater than 80 decibels hearing level (dB HL).
- No contraindications to MRI or MEG scanning, such as claustrophobia or metallic implants.
- Age 18 to 80 years.
- Right-handed.
- Baseline Tinnitus Handicap Inventory score of 38 or higher.
- Able to understand and complete examinations, assessments, and treatment procedures under physician guidance.
- Willing to participate and able to provide written informed consent before treatment.
Exclusion Criteria:
- Inner ear or auditory nerve disorders, including sudden sensorineural hearing loss, Meniere disease, otosclerosis, or acoustic neuroma.
- External or middle ear diseases, including otitis externa, foreign body in the external auditory canal, eczema of the external auditory canal, cerumen impaction, acute or chronic otitis media with effusion, or acute or chronic suppurative otitis media.
- Non-otogenic tinnitus caused by acute or chronic systemic diseases involving hematologic, endocrine, renal, or other major organ systems.
- Objective tinnitus, including myogenic, vascular, or patulous eustachian tube-related tinnitus.
- Cognitive impairment or tinnitus caused by other neurological diseases, including stroke, epilepsy, traumatic brain injury, severe headache history, severe central ischemia, brain tumor, neurasthenia, or post-neurosurgical tinnitus.
- Severe cardiovascular or cerebrovascular disease, intracranial space-occupying disease, tumor, or severe pulmonary, hepatic, renal, or hematopoietic disease.
- Pregnancy or lactation.
- Psychiatric disease, impaired consciousness, or inability to cooperate with examinations or treatment.
- Participation in another conflicting clinical trial within 6 months before enrollment or currently participating in another conflicting clinical trial.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Acupuncture
Participants in this arm will receive standardized acupuncture treatment twice weekly for 5 consecutive weeks, with 10 sessions in total.
Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6).
Needles will be retained for 20 minutes.
Participants will also receive tinnitus-related health education.
|
Standardized acupuncture treatment will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total.
Acupuncture will be performed at Tinghui (GB2), Shuaigu (GB8), Taixi (KI3), Taibai (SP3), Yifeng (TE17), and Zhigou (TE6).
Needles will be inserted according to standardized acupoint locations and retained for 20 minutes.
Participants will also receive tinnitus-related health education.
|
|
가짜 비교기: Sham Acupuncture
Participants in this arm will receive non-penetrating sham acupuncture twice weekly for 5 consecutive weeks, with 10 sessions in total.
The same acupoints as the acupuncture group will be used.
Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation.
Needles will be retained for 20 minutes.
Participants will also receive tinnitus-related health education.
|
Non-penetrating sham acupuncture will be administered twice weekly for 5 consecutive weeks, with 10 sessions in total.
The same acupoints as the acupuncture group will be used.
Blunt-tip needles will contact the skin surface without skin penetration or manual needle manipulation.
Needles will be retained for 20 minutes.
Participants will also receive tinnitus-related health education.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
기간: Baseline and Week 5
|
The Tinnitus Handicap Inventory is a 25-item questionnaire used to assess tinnitus-related handicap.
The total score ranges from 0 to 100, with higher scores indicating more severe tinnitus-related handicap.
The primary outcome is the change in Tinnitus Handicap Inventory score from baseline to Week 5.
|
Baseline and Week 5
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index Score
기간: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
The Pittsburgh Sleep Quality Index is used to assess sleep quality.
Higher scores indicate poorer sleep quality.
The change from baseline will be compared between the acupuncture and sham acupuncture groups.
|
Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
|
Change in Tinnitus Loudness Visual Analog Scale Score
기간: Baseline, immediately after the first treatment session, Week 1, Week 3, Week 5, Week 9, and Week 17
|
The tinnitus loudness visual analog scale is used to assess perceived tinnitus loudness.
Higher scores indicate greater tinnitus loudness.
The change from baseline will be compared between groups.
|
Baseline, immediately after the first treatment session, Week 1, Week 3, Week 5, Week 9, and Week 17
|
|
Change in Tinnitus Severity Visual Analog Scale Score
기간: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
The tinnitus severity visual analog scale is used to assess the subjective severity or impact of tinnitus.
Higher scores indicate greater tinnitus-related severity or impact.
The change from baseline will be compared between groups.
|
Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
|
Change in Self-Rating Anxiety Scale Score
기간: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
The Self-Rating Anxiety Scale is used to assess anxiety symptoms.
Higher scores indicate more severe anxiety symptoms.
The change from baseline will be compared between groups.
|
Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
|
Change in Self-Rating Depression Scale Score
기간: Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
The Self-Rating Depression Scale is used to assess depressive symptoms.
Higher scores indicate more severe depressive symptoms.
The change from baseline will be compared between groups.
|
Baseline, Week 1, Week 3, Week 5, Week 9, and Week 17
|
|
Change in Pure Tone Audiometry Thresholds
기간: Baseline ,week1, Week 5
|
Pure tone audiometry will be used to assess hearing thresholds.
The change from baseline will be compared between the acupuncture and sham acupuncture groups.
|
Baseline ,week1, Week 5
|
|
Change in Tinnitus Matching Loudness
기간: Baseline ,week1, Week 5
|
Tinnitus matching loudness will be assessed using audiological testing.
The change from baseline will be compared between groups.
|
Baseline ,week1, Week 5
|
|
Change in Distortion Product Otoacoustic Emissions
기간: Baseline ,week1, Week 5
|
Distortion product otoacoustic emissions will be used to evaluate cochlear outer hair cell function.
The change from baseline will be compared between groups.
|
Baseline ,week1, Week 5
|
|
Incidence of Adverse Events
기간: From baseline through Week 17
|
All adverse events and treatment-related adverse events will be recorded throughout the study.
The incidence of adverse events will be compared between the acupuncture and sham acupuncture groups.
|
From baseline through Week 17
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Magnetoencephalography (MEG) Power Spectral Density
기간: Baseline, after the first treatment session, and Week 5
|
Magnetoencephalography will be used as an exploratory neuroimaging outcome to assess changes in brain power spectral density from baseline.
|
Baseline, after the first treatment session, and Week 5
|
|
Change in Functional Magnetic Resonance Imaging (fMRI) Functional Connectivity
기간: Baseline and Week 5
|
Functional magnetic resonance imaging will be used as an exploratory neuroimaging outcome to assess changes in brain functional connectivity from baseline.
|
Baseline and Week 5
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
스폰서
협력자
협력자
수사관
수사관
- 수석 연구원: Yun Li, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 10일
기본 완료 (추정된)
기본 완료
2026년 12월 31일
연구 완료 (추정된)
연구 완료
2027년 3월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SH9H-2026-T202-1
- 2025CROC07 (기타 보조금/기금 번호: Shanghai Ninth People's Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared because the current ethics approval and informed consent do not include a plan for external sharing of de-identified individual participant data.
Aggregate study results may be disseminated through academic publications.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .