Bell Palsy Clinical Trial
Official title:
A Randomized Trial Comparing Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | November 14, 2024 |
Est. primary completion date | November 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Diagnosed as BP by specialist. 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: 1. Facial palsy caused by other diseases or injury. 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. |
Country | Name | City | State |
---|---|---|---|
China | The Third Affiliated hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Third Affiliated hospital of Zhejiang Chinese Medical University | The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang University |
China,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05679752 -
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
|
N/A | |
Terminated |
NCT03996525 -
Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury
|
N/A | |
Enrolling by invitation |
NCT02179684 -
Surgery or Clincial Follow up, in Patients With Bell' s Palsy
|
N/A | |
Completed |
NCT04807491 -
Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
|
N/A | |
Completed |
NCT03592797 -
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis
|
N/A | |
Recruiting |
NCT03781700 -
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
|
Phase 4 | |
Recruiting |
NCT04406376 -
Do We Need to Taper Down Steroid Therapy for Bell's Palsy
|
Phase 4 | |
Recruiting |
NCT06029855 -
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
|
N/A | |
Recruiting |
NCT06459830 -
Mime Therapy With and Without Neural Mobilization in Bell's Palsy.
|
N/A | |
Recruiting |
NCT06340009 -
MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy
|
N/A | |
Completed |
NCT04280120 -
Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT05891106 -
AONDA Therapeutic Indication Study I
|
||
Completed |
NCT03974763 -
Function and Form Outcomes in Patients With Facial Paralysis
|
||
Active, not recruiting |
NCT05997199 -
The Effect Vitamin D on the Recovery Rate of Bell Palsy
|
||
Completed |
NCT04412733 -
EFFECTÄ°VENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
|
N/A | |
Recruiting |
NCT06028191 -
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
|
N/A | |
Recruiting |
NCT05582915 -
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
|
||
Terminated |
NCT03836989 -
Electrical Stimulation to Promote Recovery in Bells Palsy
|
N/A | |
Recruiting |
NCT05270187 -
Multiwave Locked System Laser for Patients With Bell's Palsy.
|
N/A | |
Recruiting |
NCT06308250 -
Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy
|
N/A |