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Acupuncture Versus Sham Acupuncture for Tinnitus

7 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

226

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yun Li, MD
  • Numero di telefono: 0086-021-63138341
  • Email: liyuncmm@126.com

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200437
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contatto:
        • Investigatore principale:
          • Ying J Tan, MD
      • Shanghai, Shanghai Municipality, Cina, 200011
        • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
        • Contatto:
        • Investigatore principale:
          • Yu G Liu, PHD
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Longhua Hospital, Shanghai University of Traditional Chinese Medicine
        • Contatto:
        • Investigatore principale:
          • Hui J Lan, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Tinnitus as the primary complaint, meeting the diagnostic criteria for subjective idiopathic tinnitus.
  2. Tinnitus duration of at least 6 months.
  3. Patent external auditory canal and intact tympanic membrane.
  4. Bilateral pure tone average no greater than 80 decibels hearing level (dB HL).
  5. No contraindications to MRI or MEG scanning, such as claustrophobia or metallic implants.
  6. Age 18 to 80 years.
  7. Right-handed.
  8. Baseline Tinnitus Handicap Inventory score of 38 or higher.
  9. Able to understand and complete examinations, assessments, and treatment procedures under physician guidance.
  10. Willing to participate and able to provide written informed consent before treatment.

Exclusion Criteria:

  1. Inner ear or auditory nerve disorders, including sudden sensorineural hearing loss, Meniere disease, otosclerosis, or acoustic neuroma.
  2. 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.
  3. Non-otogenic tinnitus caused by acute or chronic systemic diseases involving hematologic, endocrine, renal, or other major organ systems.
  4. Objective tinnitus, including myogenic, vascular, or patulous eustachian tube-related tinnitus.
  5. 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.
  6. Severe cardiovascular or cerebrovascular disease, intracranial space-occupying disease, tumor, or severe pulmonary, hepatic, renal, or hematopoietic disease.
  7. Pregnancy or lactation.
  8. Psychiatric disease, impaired consciousness, or inability to cooperate with examinations or treatment.
  9. Participation in another conflicting clinical trial within 6 months before enrollment or currently participating in another conflicting clinical trial.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: Acupuncture
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.
Comparatore fittizio: 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.
Procedura: Sham Acupuncture
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pittsburgh Sleep Quality Index Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Magnetoencephalography (MEG) Power Spectral Density
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaboratori

Shanghai University of Traditional Chinese Medicine

Investigatori

  • Investigatore principale: Yun Li, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 luglio 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SH9H-2026-T202-1
  • 2025CROC07 (Altro numero di sovvenzione/finanziamento: Shanghai Ninth People's Hospital)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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