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Effekten af manuel akupunktur på akut primær tinnitus: Et multicenter randomiseret kontrolleret klinisk forsøg

10. juni 2026 opdateret af: Dan Bing

Manuel akupunktur ved akut primær tinnitus

Dette multicenter-kliniske forsøg har til formål at undersøge effektiviteten og sikkerheden af manuel akupunktur ved akut primær tinnitus.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et multicentrisk, randomiseret, enkeltblindt, sham-kontrolleret forsøg. Den samlede forsøgsperiode var 14 uger, inklusive to ugers baselinevurdering, fire ugers behandling efter randomisering og otte ugers opfølgning. Informert samtykke vil blive indhentet fra hver patient før randomisering. Efter baselinevurderingen vil en uafhængig undersøger randomisere kvalificerede patienter i et 1:1:1-forhold til at modtage manuel akupunktur, sham-akupunktur eller sædvanlig behandling. Alle patienter vil modtage 10 sessioner af 30 minutters akupunkturbehandlinger eller sædvanlig behandling over en fire-ugers behandlingsperiode. De vil blive behandlet tre gange om ugen for at opfylde en to-ugers initial behandlingsforløb og derefter behandlet to gange om ugen for at opfylde en to-ugers konsolideringsbehandlingsforløb. I både den manuelle og sham-akupunkturgruppe vil akupunkturbehandlingen begynde efter randomisering. I sædvanlig behandlingsgruppen vil patienterne modtage gratis akupunktur efter at have ventet 12 uger.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Alder mellem 18 og 65 år (begge køn);
  2. Hovedklagen er tinnitus;
  3. Opfylder diagnostiske kriterier for primær tinnitus;
  4. Tinnitus skal være generende med en THI-score mellem 28 og 76 og have varet i ≥2 uger;
  5. Tinnitusvarighed under 6 måneder;
  6. Ingen akupunkturerfaring i de sidste 3 måneder;
  7. Ingen brug af tinnitusmedicin inden for 2 uger før behandling, herunder intratympanale injektioner, postaurikulære injektioner, kortikosteroider, traditionel kinesisk medicin (TCM) eller patenteret kinesisk medicin m.v.;
  8. Samtykker til at underskrive informeret samtykkeerklæring.

Eksklusionskriterier:

  1. Objektiv tinnitus;
  2. Pulserende tinnitus;
  3. Diagnosticeret som sekundær tinnitus vurderet af audiologer og klinikere;
  4. Kombineret ledningshøretab (bekræftet ved unormal otoskopi eller unormal tympanogram);
  5. Havde kontraindikationer for akupunktur, herunder gravide, svær anæmi, koagulationsforstyrrelser m.v.;
  6. Har vanskeligheder med at udtrykke symptomer klart, såsom svære psykiske lidelser eller kognitive forstyrrelser;
  7. Lider i øjeblikket af andre alvorlige akutte eller kroniske organiske sygdomme, såsom cerebrovaskulære, kardiovaskulære, lever-, nyre-, hæmatologiske sygdomme, infektionssygdomme eller ondartede svulster;
  8. Deltog i andre kliniske forsøg, især dem tæt relateret til tinnitusbehandling, såsom lydterapi;
  9. Har et stærkt ønske om medicinsk behandling.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Manual acupuncture group
Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.
Adfærdsmæssigt: Usaual care
Sundhedsoplysning og standardevaluering relateret til tinnitus
Andet: Manual acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks.
Sham-komparator: Sham acupuncture
Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks.
Adfærdsmæssigt: Usaual care
Sundhedsoplysning og standardevaluering relateret til tinnitus
Andet: Sham acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks.
Andet: Usual care
Health education and guidance related to tinnitus
Adfærdsmæssigt: Usaual care
Sundhedsoplysning og standardevaluering relateret til tinnitus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tinnitus Handicap Inventory (THI, 0-100)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and >76 points indicate catastrophic handicap.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Tinnitus Functional Index (TFI, 0-100)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effective response rate of THI
Tidsramme: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points.
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI.
Tidsramme: End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points.
End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for aural fullness
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Visual Analogue Scale (VAS) for tinnitus
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The pittsburgh Sleep Qual-ityIndex (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has 19 questions which can be grouped into seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep dis-turbances, use of sleeping medication, and daytime dysfunction.The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), yielding domain scores and an overall score (0-100; higher scores indicate better quality of life).
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9)
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Adverse Events
Tidsramme: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Adverse events assessed each acupuncture treatment visit using a acupuncture adverse events questionnaire recording presence and severity of side effects (e.g., subcutaneous hemorrhage, minor bleeding) related to acupuncture, plus event frequency.
Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Assessment of blinding
Tidsramme: At 12 weeks after randomization
At the end of the study, we will determine the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin.
At 12 weeks after randomization
Acupuncture expectancy scale(AES)
Tidsramme: Baseline visit, and end of treatment at 4 weeks after randomization,.
The Acupuncture Expectancy Scale (AES) will be completed by participants in the verum and sham acupuncture groups at baseline and at the end of treatment (4 weeks after randomization). The questionnaire will not be administered to the usual care group.
Baseline visit, and end of treatment at 4 weeks after randomization,.
Massachusetts General Hospital Acupuncture Sensation Scale(MASS)
Tidsramme: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
The Massachusetts General Hospital Acupuncture Sensation Scale, which includes twelve specific descriptors-soreness, aching, deep pressure, heaviness, fullness or distension, tingling, numbness, sharp pain, dull pain, warmth, cold, and throbbing-as well as an open field for patients to describe the sensation in their own words, will be administered following a brief explanation of de qi sensations by the acupuncturist to participants in the verum acupuncture and sham acupuncture groups, while the usual care group will not receive this questionnaire.
Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
Auditory Sensitivity Scale
Tidsramme: Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.
Auditory Sensitivity Scale is a self-report questionnaire consisting of general questions on tinnitus and sound intolerance, along with 25 items rated on different scoring scales (e.g., 0/2/5, 0/1/2, 0/10), and provides a severity classification based on the total score: 31-55 for mild, 56-80 for moderate, 81-100 for severe, and 101-126 for very severe.
Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10-item short version of the Big Five Inventory (BFI-10)
Tidsramme: Baseline visit(before randomization)
Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10).
Baseline visit(before randomization)
Pure-Tone Audiometry(PTA)
Tidsramme: Baseline visit(before randomization)
Pure tone audiometry is conducted under standard soundproof conditions using the Hughson-Westlake method to obtain the air conduction threshold (bone conduction threshold is only used for diagnosis, to determine whether there is conductive hearing loss, and to assist in the screening process; statistical analysis only uses the air conduction threshold). The standard test frequencies range from 0.25 to 8 kHz. If conditions permit, extended high frequencies (Extended High Frequency, EHF; ≥ 9-16 kHz) are added, and necessary masking is performed in accordance with the norms.
Baseline visit(before randomization)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dan Bing

Samarbejdspartnere

Taihe Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Hubei Xinhua Hospital
Qianjiang Central Hospital

Efterforskere

  • Ledende efterforsker: Dan Bing, PhD, Tongji Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

30. oktober 2027

Studieafslutning (Anslået)

12. december 2027

Datoer for studieregistrering

Først indsendt

31. marts 2026

Først indsendt, der opfyldte QC-kriterier

31. marts 2026

Først opslået (Faktiske)

7. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Tinnitus(2025-TJ-MA)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD efter anonymisering kan deles på individuel anmodning til hovedforskeren på didibing1981@aliyun.com

IPD-delingstidsramme

IPD og supplerende oplysninger vil være tilgængelige inden for 2 år efter resultaternes offentliggørelse.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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