Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
NCT ID: NCT06063954
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low-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.
electroacupuncture
Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin.
Intermittent 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.
electroacupuncture
Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin.
Interventions
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electroacupuncture
Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin.
Eligibility Criteria
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Inclusion Criteria
2. The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
3. 18 years ≤ age ≤ 65 years.
4. 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.
5. Signed informed consent and volunteered to participate in this study.
Exclusion Criteria
2. Ramsey-Hunt syndrome.
3. Bilateral facial palsy.
4. History of previous facial palsy.
5. Manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of BP.
6. History of surgery on face.
7. Combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders.
8. Installing pacemakers.
9. Pregnant and lactating patients.
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Zhejiang University
OTHER
The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Jing Sun
Deputy Chief physician of Traditional Chinese Medicine
Principal Investigators
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Jing Sun, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated hospital of Zhejiang Chinese Medical University
Locations
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The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
The Third Affiliated hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Hangzhou First People' s Hospital, Hangzhou
Hangzhou, Zhejing, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu ZD, He JB, Guo SS, Yang ZX, Shen J, Li XY, Liang W, Shen WD. Effects of electroacupuncture therapy for Bell's palsy from acute stage: study protocol for a randomized controlled trial. Trials. 2015 Aug 25;16:378. doi: 10.1186/s13063-015-0893-9.
Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013 Apr 2;185(6):473-9. doi: 10.1503/cmaj.121108. Epub 2013 Feb 25.
Kim SH, Ryu EW, Yang CW, Yeo SG, Park MS, Byun JY. The prognostic value of electroneurography of Bell's palsy at the orbicularis oculi versus nasolabial fold. Laryngoscope. 2016 Jul;126(7):1644-8. doi: 10.1002/lary.25709. Epub 2015 Oct 15.
Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.
Marotta N, Demeco A, Inzitari MT, Caruso MG, Ammendolia A. Neuromuscular electrical stimulation and shortwave diathermy in unrecovered Bell palsy: A randomized controlled study. Medicine (Baltimore). 2020 Feb;99(8):e19152. doi: 10.1097/MD.0000000000019152.
Gokce Kutuk S, Ozkan Y, Topuz MF, Kutuk M. The Efficacy of Electro-Acupuncture Added to Standard Therapy in the Management of Bell Palsy. J Craniofac Surg. 2020 Oct;31(7):1967-1970. doi: 10.1097/SCS.0000000000006537.
Vrabec JT, Backous DD, Djalilian HR, Gidley PW, Leonetti JP, Marzo SJ, Morrison D, Ng M, Ramsey MJ, Schaitkin BM, Smouha E, Toh EH, Wax MK, Williamson RA, Smith EO; Facial Nerve Disorders Committee. Facial Nerve Grading System 2.0. Otolaryngol Head Neck Surg. 2009 Apr;140(4):445-50. doi: 10.1016/j.otohns.2008.12.031.
Bian Z, Wang J, Fang F, Yu B, Shi Y, Wan Y, Hong M, Ji C, Shao X, Liang Y, Fang J, Sun J. Study protocol for a randomized trial comparing two electroacupuncture waveforms for different severity groups of Bell palsy. Front Neurol. 2024 Nov 20;15:1471605. doi: 10.3389/fneur.2024.1471605. eCollection 2024.
Other Identifiers
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GZY-ZJ-KY-23071-01
Identifier Type: -
Identifier Source: org_study_id
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