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Acupuncture Versus Sham Acupuncture for Tinnitus

7. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

226

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: 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.
Schein-Komparator: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Tinnitus Handicap Inventory Score From Baseline to Week 5
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pittsburgh Sleep Quality Index Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Magnetoencephalography (MEG) Power Spectral Density
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Mitarbeiter

Shanghai University of Traditional Chinese Medicine

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. März 2027

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SH9H-2026-T202-1
  • 2025CROC07 (Andere Zuschuss-/Finanzierungsnummer: Shanghai Ninth People's Hospital)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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