Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT06063954 per Paralisi di Bell è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy 120
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06063954 è uno studio interventistico per Paralisi di Bell, attualmente in arruolamento. Avviato il 15 novembre 2023, prevede di arruolare 120 partecipanti. Sotto la guida di The Third Affiliated hospital of Zhejiang Chinese Medical University, dovrebbe concludersi entro il 31 dicembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 21 ottobre 2024.
Sommario breve
Bell palsy (BP) is the most common cause of acute facial palsy, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture (EA) received attention as an alternative and complementary treatment method. The low-frequency continuous wave EA and the intermittent wave EA have been used in the management of BP. The aim of this study is to compare the effica...Mostra di più
Descrizione dettagliata
The investigators will recruit 60 patients with BP whose ENoG test indicate a mild to moderate facial nerve damage, as indicated by the ratio of amplitude of the compound muscle action potential (CMAP) of the affected side comparing to normal side is 20% or higher. And the investigators will recruit 60 patients with BP whose ENoG test indicate a severe damage, as indicated by the ratio of amplitude of the CMAP of the...Mostra di più
Titolo ufficiale
A Randomized Trial Comparing Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
Patologie
Paralisi di BellPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- GZY-ZJ-KY-23071-01
Numero NCT
Data di inizio (effettiva)
2023-11-15
Ultimo aggiornamento pubblicato
2024-10-21
Data di completamento (stimata)
2025-12-31
Arruolamento (previsto)
120
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Bell palsy
Acupuncture treatment
Clinical study
Acupuncture treatment
Clinical study
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleLow-frequency continuous wave group Low-frequency continuous wave EA In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2Hz continuous wave will be used for 20 min. | Elettroagopuntura Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin. |
SperimentaleIntermittent wave group Intermittent wave EA In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 40Hz intermittent wave will be used for 20 min. | Elettroagopuntura Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change from Baseline score of the Facial Nerve Grading System 2.0 | Evaluation of the facial nerve function using the Facial Nerve Grading System 2.0 (FNGS 2.0). In the FNGS 2.0, the minimal score is 4, which indicates normal function, and the maximal score is 24, which indicates the worst function. | Baseline, the end of week 4 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change from Baseline score of the Sunnybrook grading scale. | Evaluation of the facial nerve function using the Sunnybrook grading scale. The Sunnybrook grading scale includes 3 subscales, which are the resting symmetry subscale, the symmetry of voluntary movement subscale, and the synkinesis subscale. Change from baseline score of each subscale and change from baseline of the composite score will be calculated. | Baseline, the end of week 4 |
Change from Baseline value of the amplitude of the compound muscle action potential (CMAP) of the affected side in the ENoG test. | The compound motor action potential (CMAP) represents the summated action potentials of all stimulated motor endplates and potentially reflects muscle hypertrophy and increased muscle contractions. | Baseline, the end of week 4 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Diagnosed as BP by specialist.
- The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
- 18 years ≤ age ≤ 65 years.
- Received prednisolone within 72 hours since initial symptoms of BP, the prednisolone dose used was 60 mg per day for 5 days and then reduced by 10 mg per day.
- Signed informed consent and volunteered to participate in this study.
- Facial palsy caused by other diseases or injury.
- Ramsey-Hunt syndrome.
- Bilateral facial palsy.
- History of previous facial palsy.
- Manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of BP.
- History of surgery on face.
- Combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders.
- Installing pacemakers.
- Pregnant and lactating patients.
The Third Affiliated hospital of Zhejiang Chinese Medical University- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Università dello Zhejiang1067 studi clinici attivi da esplorare
Parte responsabile dello studio
Jing Sun, Investigatore principale, Deputy Chief physician of Traditional Chinese Medicine, The Third Affiliated hospital of Zhejiang Chinese Medical University
Contatti principali dello studio
Contatto: Jing Sun, MD, Ph.D, 86-13429610268, [email protected]
Contatto: Zhiyuan Bian, 86-18668128321, [email protected]
3 Centri dello studio in 1 paesi
Zhejiang
The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310006, China
Binyan Yu, PhD, Contatto, 86-13758271294, [email protected]
In arruolamento
The Third Affiliated hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China
Jing Sun, MD, Ph.D, Contatto, 86-13429610268, [email protected]
Zhiyuan Bian, Contatto, 86-18668128321, [email protected]
Jing Sun, MD, Ph.D, Investigatore principale
In arruolamento
Zhejing
Hangzhou First People' s Hospital, Hangzhou, Hangzhou, Zhejing, 310006, China
Yan Shi, PhD, Contatto, 13867439433, [email protected]
In arruolamento