Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
A Randomized Trial Comparing Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
1 other identifier
interventional
120
1 country
3
Brief Summary
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 efficacy and safety of these two electroacupuncture waveforms for different severity groups of BP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 3, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 21, 2024
October 1, 2024
2.1 years
September 26, 2023
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change from Baseline score of the Sunnybrook grading scale.
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.
Baseline, the end of week 4
Study Arms (2)
Low-frequency continuous wave group
EXPERIMENTALLow-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.
Intermittent wave group
EXPERIMENTALIntermittent 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.
Interventions
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
You may qualify if:
- Diagnosed as BP by specialist.
- The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006, China
The Third Affiliated hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053, China
Hangzhou First People' s Hospital, Hangzhou
Hangzhou, Zhejing, 310006, China
Related Publications (8)
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.
PMID: 26303741BACKGROUNDXu 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.
PMID: 23439629BACKGROUNDKim 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.
PMID: 26466560BACKGROUNDBaugh 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.
PMID: 24189771BACKGROUNDMarotta 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.
PMID: 32080092BACKGROUNDGokce 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.
PMID: 32472874BACKGROUNDVrabec 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.
PMID: 19328328BACKGROUNDBian 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.
PMID: 39634773DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Sun, MD, Ph.D
The Third Affiliated hospital of Zhejiang Chinese Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief physician of Traditional Chinese Medicine
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 3, 2023
Study Start
November 15, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share