- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07598175
Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
The goal of this clinical study is to find out whether different electronic acupuncture wave forms can effectively treat recovery-stage Bell's palsy in adults and evaluate their safety.
The main questions it aims to answer are:
- Can targeted electronic acupuncture wave forms improve facial nerve function in patients with Bell's palsy?
- What is the optimal electronic acupuncture waveform for different degrees of facial nerve injury?
- What adverse events may occur during electronic acupuncture treatment? Researchers will compare low-frequency continuous wave electronic acupuncture and intermittent wave electronic acupuncture to determine which waveform works better for recovery-stage Bell's palsy.
Participants will:
- Receive either low-frequency continuous wave electronic acupuncture or intermittent wave electronic acupuncture every other day for 4 weeks
- Undergo surface sEMG and ENoG examinations at baseline, Week 2, and Week 4
- Complete facial function assessments and safety evaluations at each clinic visit
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jing Sun
- Telefonnummer: 13429610268
- E-post: sunjing0268@163.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria for Bell's Palsy Subjects:
- Meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender;
- Disease course in recovery phase (21 days ≤ course ≤ 6 months) and not recovered (FNGS 2.0 score >4);
- Voluntarily participate in this study and sign informed consent.
Inclusion Criteria for Healthy Subjects:
- Do not meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender, matched to Bell's palsy subjects within 5 years for age and gender;
- Normal facial nerve function, FNGS 2.0 score = 4;
- Voluntarily participate in this study and sign informed consent.
Exclusion Criteria for Bell's Palsy Subjects:
- Facial trauma, skin lesions, or other diseases that may cause facial paralysis symptoms;
- Diagnosed with Ramsay Hunt syndrome (herpes zoster oticus);
- Bilateral facial paralysis;
- Previous history of facial paralysis;
- Facial synkinesis, contracture, or spasm already present;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Exclusion Criteria for Healthy Subjects:
- Facial trauma, skin lesions, or other diseases that may affect facial muscle activity;
- Previous history of facial paralysis;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Non-severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimentell: Non-severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimentell: Severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimentell: Severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FNGS2.0
Tidsram: week4
|
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
|
week4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sunnybrook Facial Grading System,SBGS
Tidsram: week4
|
1.SBGS:Score range: 0-100, with higher scores indicating better facial nerve function.
|
week4
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GZY-KJS-ZJ-2026-056
Läkemedels- och apparatinformation, studiedokument
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