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Acupuncture Versus Sham Acupuncture for Tinnitus

7. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

226

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yun Li, MD
  • Telefonní číslo: 0086-021-63138341
  • E-mail: liyuncmm@126.com

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Postup: 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.
Falešný srovnávač: 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.
Postup: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Pittsburgh Sleep Quality Index Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Magnetoencephalography (MEG) Power Spectral Density
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Spolupracovníci

Shanghai University of Traditional Chinese Medicine

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. března 2027

Termíny zápisu do studia

První předloženo

7. července 2026

První předloženo, které splnilo kritéria kontroly kvality

7. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SH9H-2026-T202-1
  • 2025CROC07 (Jiné číslo grantu/financování: Shanghai Ninth People's Hospital)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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