Effekt av manuell akupunktur på akutt primær tinnitus: En multiklinisk randomisert kontrollert klinisk studie
10. juni 2026 oppdatert av: Dan Bing
Manuell akupunktur ved akutt primær tinnitus
Denne multikliniske kliniske studien har som mål å undersøke effekten og sikkerheten av manuell akupunktur ved akutt primær tinnitus.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Dette er en multicenter randomisert, enkeltblindet, sham-kontrollert studie.
Den totale studiperioden var 14 uker, inkludert to uker med baselinevurdering, fire uker med behandling etter randomisering, og åtte uker med oppfølging.
Informert samtykke vil bli innhentet fra hver pasient før randomisering.
Etter baselinevurderingen vil en uavhengig forsker randomisere kvalifiserte pasienter i et 1:1:1-forhold for å motta manuell akupunktur, sham-akupunktur eller vanlig behandling.
Alle pasienter vil motta 10 økter med 30 minutters akupunkturbehandlinger eller vanlig behandling over en fire ukers behandlingsperiode.
De vil bli behandlet tre ganger i uken for å oppfylle en to ukers initial behandlingskurs og deretter behandlet to ganger i uken for å oppfylle en to ukers konsolideringsbehandlingskurs.
I både manuell og sham-akupunkturgruppen vil akupunkturbehandlingen begynne etter randomisering.
I vanlig behandlingsgruppen vil pasienter motta akupunktur gratis etter å ha ventet 12 uker.
Studietype
Intervensjonell
Registrering (Antatt)
180
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dan Bing, PhD
- Telefonnummer: 86+13971058388
- E-post: didibing1981@aliyun.com
Studer Kontakt Backup
- Navn: Dan Bing, PhD
- Telefonnummer: 86-13971058388
- E-post: didibing1981@aliyun.com
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Alder mellom 18 og 65 år (begge kjønn);
- Hovedklagen er tinnitus;
- Oppfyller diagnostiske kriterier for primær tinnitus;
- Tinnitusen bør være plagsom, med en THI-score mellom 28 og 76, og vare i ≥2 uker;
- Tinnitusens varighet mindre enn 6 måneder;
- Ingen akupunkturbehandling de siste 3 månedene;
- Ingen bruk av tinnitusmedisiner innen 2 uker før behandlingen, inkludert intratympanale injeksjoner, postaurikulære injeksjoner, kortikosteroider, tradisjonell kinesisk medisin (TCM) eller patenterte kinesiske medisiner osv.;
- Samtykker til å signere informert samtykkeerklæring.
Eksklusjonskriterier:
- Objektiv tinnitus;
- Pulserende tinnitus;
- Diagnostisert som sekundær tinnitus etter vurdering av audiologer og klinikere;
- Kombinert ledningshørselshemning (bekreftet av unormal otoskopi eller unormal tympanogram);
- Hadde kontraindikasjoner for akupunktur, inkludert gravide, alvorlig anemi, koagulasjonsforstyrrelser, etc;
- Har vanskeligheter med å uttrykke symptomene klart, som alvorlige psykiske lidelser eller kognitiv svikt;
- Lider for tiden av andre alvorlige akutte eller kroniske organiske sykdommer, som cerebrovaskulære, kardiovaskulære, lever-, nyre-, hematologiske sykdommer, infeksjonssykdommer eller maligne tumorer;
- Deltok i andre kliniske studier, spesielt de som er nært knyttet til tinnitusbehandling, som lydterapi;
- Har et sterkt ønske om medikamentell behandling.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Manual acupuncture group
Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.
|
Helseundervisning og standard evaluering relatert til tinnitus
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.
|
Helseundervisning og standard evaluering relatert til tinnitus
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.
|
|
Annen: Usual care
Health education and guidance related to tinnitus
|
Helseundervisning og standard evaluering relatert til tinnitus
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
|
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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.
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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.
|
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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.
|
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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.
|
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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 |
Tiltaksbeskrivelse |
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)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dan Bing, PhD, Tongji Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. juni 2026
Primær fullføring (Antatt)
30. oktober 2027
Studiet fullført (Antatt)
12. desember 2027
Datoer for studieregistrering
Først innsendt
31. mars 2026
Først innsendt som oppfylte QC-kriteriene
31. mars 2026
Først lagt ut (Faktiske)
7. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Tinnitus(2025-TJ-MA)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
IPD etter avidentifisering kan deles på individuell forespørsel til hovedforskeren på didibing1981@aliyun.com
IPD-delingstidsramme
IPD og støtteinformasjon vil være tilgjengelig innen 2 år etter publisering av resultatene.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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