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Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy

Primary Purpose

Bell Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Bell palsy, Acupuncture treatment, Clinical study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-frequency continuous wave group

Intermittent wave group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06063954
Brief Title
Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
Official Title
A Randomized Trial Comparing Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 23, 2023 (Anticipated)
Primary Completion Date
September 23, 2024 (Anticipated)
Study Completion Date
September 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
We 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 we 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 affected side comparing to normal side is less than 20%. Both the two types of patients will be randomly divided into either the low-frequency continuous wave group, or the intermittent wave group, and receive 4 weeks treatment. The primary outcomes is change from baseline score of the Facial Nerve Grading System 2.0. The secondary outcomes are change from baseline score of the Sunnybrook grading scale, and change from baseline value of the amplitude of the CMAP of the affected side in the ENoG test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell palsy, Acupuncture treatment, Clinical study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-frequency continuous wave group
Arm Type
Experimental
Arm Description
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.
Arm Title
Intermittent wave group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin.
Primary Outcome Measure Information:
Title
Change from Baseline score of the Facial Nerve Grading System 2.0
Description
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.
Time Frame
Baseline, the end of week 4
Secondary Outcome Measure Information:
Title
Change from Baseline score of the Sunnybrook grading scale.
Description
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.
Time Frame
Baseline, the end of week 4
Title
Change from Baseline value of the amplitude of the compound muscle action potential (CMAP) of the affected side in the ENoG test.
Description
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.
Time Frame
Baseline, the end of week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sun, MD, Ph.D
Phone
86-13429610268
Email
sunjing0268@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyuan Bian
Phone
86-18668128321
Email
bianbk55@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Sun, MD, Ph.D
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sun, MD, Ph.D
Phone
86-13429610268
Email
sunjing0268@163.com
First Name & Middle Initial & Last Name & Degree
Zhiyuan Bian
Phone
86-18668128321
Email
bianbk55@163.com
First Name & Middle Initial & Last Name & Degree
Jing Sun, MD, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26303741
Citation
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.
Results Reference
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PubMed Identifier
23439629
Citation
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.
Results Reference
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PubMed Identifier
26466560
Citation
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.
Results Reference
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PubMed Identifier
24189771
Citation
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.
Results Reference
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PubMed Identifier
32080092
Citation
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.
Results Reference
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PubMed Identifier
32472874
Citation
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.
Results Reference
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PubMed Identifier
19328328
Citation
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.
Results Reference
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Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy

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