Effekt av manuell akupunktur på akutt primær tinnitus: En multiklinisk randomisert kontrollert klinisk studie
Manuell akupunktur ved akutt primær tinnitus
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
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,
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
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Eksperimentell: Manual acupuncture group
Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period.
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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.
|
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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.
|
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Annen: Usual care
Health education and guidance related to tinnitus
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Helseundervisning og standard evaluering relatert til tinnitus
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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.
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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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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.
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25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment.
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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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Effective response rate of THI
Tidsramme: 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 THI is defined as the proportion of patients with a THI score decrease of ≥7 points.
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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.
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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.
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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.
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We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness.
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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.
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The VAS will be used to assess the intensity of tinnitus.
0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness".
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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.
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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.
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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.
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The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression.
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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 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.
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The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety.
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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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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.
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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).
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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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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.
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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.
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Adverse Events
Tidsramme: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
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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.
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Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
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Assessment of blinding
Tidsramme: At 12 weeks after randomization
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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.
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At 12 weeks after randomization
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Acupuncture expectancy scale(AES)
Tidsramme: Baseline visit, and end of treatment at 4 weeks after randomization,.
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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.
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Baseline visit, and end of treatment at 4 weeks after randomization,.
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Massachusetts General Hospital Acupuncture Sensation Scale(MASS)
Tidsramme: Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
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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.
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Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10)
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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.
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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.
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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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Andre resultatmål
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)
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Pure-Tone Audiometry(PTA)
Tidsramme: Baseline visit(before randomization)
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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.
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Baseline visit(before randomization)
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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Etterforskere
Etterforskere
- Hovedetterforsker: Dan Bing, PhD, Tongji Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- Tinnitus(2025-TJ-MA)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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