Acupuncture Versus Sham Acupuncture for Tinnitus
7 de julio de 2026 actualizado por: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
226
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yun Li, MD
- Número de teléfono: 0086-021-63138341
- Correo electrónico: liyuncmm@126.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200437
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
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Contacto:
- Ling J Zhang, PHD
- Número de teléfono: 0086-021-65161782
- Correo electrónico: eternityz@sina.com
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Investigador principal:
- Ying J Tan, MD
-
Shanghai, Shanghai Municipality, Porcelana, 200011
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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Contacto:
- Yun Li, MD
- Número de teléfono: 0086-021-021-63138341
- Correo electrónico: liyuncmm@126.com
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Investigador principal:
- Yu G Liu, PHD
-
Shanghai, Shanghai Municipality, Porcelana, 200032
- Longhua Hospital, Shanghai University of Traditional Chinese Medicine
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Contacto:
- Hui J Lan, MD
- Número de teléfono: 0086-021-64385700
- Correo electrónico: lanjh_ent@163.com
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Investigador principal:
- Hui J Lan, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador falso: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Incidence of Adverse Events
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Magnetoencephalography (MEG) Power Spectral Density
Periodo de tiempo: 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
|
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Change in Functional Magnetic Resonance Imaging (fMRI) Functional Connectivity
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Yun Li, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SH9H-2026-T202-1
- 2025CROC07 (Otro número de subvención/financiamiento: Shanghai Ninth People's Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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