scholarly journals Protocol for randomized controlled trial of electric stimulation with high-volt twin peak versus placebo for facial functional recovery from acute Bell’s palsy in patients with poor prognostic factors

2020 ◽  
Vol 7 ◽  
pp. 205566832096414
Author(s):  
Myriam Loyo ◽  
Margaret McReynold ◽  
Jess C Mace ◽  
Michelle Cameron

Background Electric stimulation (ES) can prevent muscle atrophy and promote tissue healing and therefore may help prevent sequelae of Bell’s palsy but due to lack of high-quality studies, the effectiveness of ES in Bell’s palsy remains controversial. Here we describe a protocol to evaluate the effects of monophasic high volt ES in patients with Bell’s palsy and poor prognosis for recovery. Results This is a protocol for a prospective, double-blinded, randomized, placebo-controlled study. Participants include adults with acute Bell’s palsy with poor prognosis for full recovery due to complete paralysis or being over age 60. ES will be a monophasic, high-volt pulsed waveform, 100μsec pulse duration, 35 hertz, motor-level intensity. Follow up will be at months 1, 2, 3 and 6. The primary outcome will be the proportion of patients with complete recovery using the eFACES tool. Secondary outcomes include patient reported quality of life measured by FaCE and the synkinesis assessment questionnaires, objective photographs, time to complete recovery, adverse effects, and tolerability. Conclusion This protocol has the potential to provide high quality evidence regarding the effects, up to 6 months after onset, of pulsed monophasic high-volt ES for patients with acute Bell’s palsy and poor prognosis for complete recovery.

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Xianjun Xiao ◽  
Qianhua Zheng ◽  
Yunzhou Shi ◽  
Leixiao Zhang ◽  
Ling Zhao ◽  
...  

Background. Acupuncture has been found to be effective for treating Bell’s palsy (BP). However, which class of BP patients will have a better response to acupuncture remains uncertain and requires investigation. Methods. We performed a secondary analysis of a multicenter, randomized, controlled trial. BP patients were randomly divided into five acupuncture treatment groups. The degree of facial nerve recovery was assessed according to the House–Brackmann grading system (HB grade). Grade I was defined as complete recovery (CR), and grades II–VI were defined as incomplete recovery (IR). The relevant patient characteristics were collected and compared between CR and IR groups by univariate and logistic regression analyses. Results. Eight-hundred twenty-six subjects were analyzed. Among these, 698 (85%) subjects had a good prognosis. No significant difference in the effectiveness of the five treatments was observed (all P>0.05). The likelihood of IR increased by 2.2% with each one-year increase in age (odds ratio (OR) 1.022, 95% confidence interval (CI) 1.005–1.038; P=0.009). The likelihood of IR increased by 9% with each kg/m2 increase in BMI (OR 1.090, 95% CI 1.019–1.165; P=0.012). The likelihood of IR at the recovery stage was higher than that at the acute stage (OR 7.996, 95% CI 4.570–13.991; P<0.001), and the likelihood of IR of patients with lesions at or above the chorda tympani was higher than that of patients with lesions below the chorda tympani (OR 1.989, 95% CI 1.256–3.150; P=0.003). The likelihood of IR increased by 281.7% with each unit increase in the HB grade (OR 2.817, 95% CI 2.113–3.756; P<0.001). Conclusions. Younger patients at the acute stage of the disease with low BMIs, low initial HB grades, and lesions below the chorda tympani were more likely to respond to acupuncture.


2021 ◽  
Vol 09 (3) ◽  
pp. 650-656
Author(s):  
Ram Lakhan Meena ◽  
Santoshkumar Bhatted ◽  
Nilam Meena

Bell’s palsy, also known as acute idiopathic lower motor neuron facial paralysis, is characterized by sud-den onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. In contemporary science, administration of steroids is the treatment of choice for complete facial palsy. Cer-tain Panchakarma procedures and internal Ayurvedic medicines have been proved to be beneficial in the management of Ardita vata. The present report deals with a case of 62-year-old male patient diagnosed as Ardita vata was treated with various Panchakarma procedures like Nasya, Shirobasti, Kukkutanda Swedana, Dashmoola Ksheer Dhoom, Gandoosh and oral Ayurveda medicines. Criteria of assessment was based on the scoring of House-Brackmann Facial Nerve Grading scale. After completion of Ayurveda treatment, the patient Shown almost complete recovery without any adverse effects. This case is an evi-dence to demonstrate the effectiveness of Ayurveda treatment in case of Ardita vata (Bell’s palsy).


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024932 ◽  
Author(s):  
Liling Zeng ◽  
Guanghai Tang ◽  
Jing Wang ◽  
Jianbin Zhong ◽  
Zhangyong Xia ◽  
...  

ObjectiveTo evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window.Study designA randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China.Participants and interventionsPatients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs hirudo and tabanus) or the ICH-2 formula (six herbs without the RBS herbs hirudo and tabanus) within 6 hours of ICH onset.OutcomesThe primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset.ResultsA total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p<0.05). All three cases of serious adverse events were in the ICH-1 group.ConclusionsUltra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1.Trialregistration numberNCT01918722.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Weizheng Zhong ◽  
Haibo Yu ◽  
Xiaodan Rao ◽  
Jianhuang Wu ◽  
Yanhua Gou ◽  
...  

To determine if the effect of manipulative acupuncture monitored by laser speckle contrast imaging (LSCI) can improve facial blood perfusion in patients with severe Bell’s palsy. This randomized, single-blind, controlled trial included 120 newly diagnosed patients (within 14 days) with severe Bell’s palsy (House–Brackmann grading system (HBGS) ≥ grade IV). The patients were randomized (1 : 1) to receive either acupoints acupuncture combined with manipulations of twirling, lifting, and thrusting treatments (manipulative acupuncture) or acupoints acupuncture therapy alone (simple acupuncture). These treatments consisted of a total of 24 sessions, three times per week, and each treatment lasted for 30 min. Following 8 weeks of treatment and 6 months after the initial onset of facial palsy, facial nerve functioning was scored (HBGS) and clinical efficacy was measured. The patients’ facial blood perfusion significantly improved following manipulative acupuncture assisted by LSCI compared with that at baseline ( P < 0.01 ). At the conclusion of the 8-week treatment, both groups showed improvement; however, the recovery rate was significantly different (manipulative acupuncture 53.3% vs. simple acupuncture 33.9%, P < 0.05 ). Follow-up analysis at 6 months after the onset of facial palsy revealed a significantly higher recovery rate (91.7% vs. 78.0%; P < 0.05 ). In addition, the number of treatments in the observation group was less than that in the simple acupuncture therapy group ( P < 0.05 ). Compared with simple acupuncture therapy, manipulative acupuncture therapy led to a more significant recovery rate in the treatment of severe Bell’s palsy and required a shorter course of treatment. This trial was registered with ChiCTR1800019463.


Cephalalgia ◽  
2003 ◽  
Vol 23 (3) ◽  
pp. 214-217 ◽  
Author(s):  
DE Jacome

A report of two female patients with persistent unilateral retroauricular pain and cranial synkinesis following Bell's palsy. Pain occurred during menses in the first patient and was exacerbated by menses in the second patient. Retroauricular pain often precedes or follows Bell's palsy. Pain normally disappears within 2 weeks from the onset of paralysis. Neurological examination, brain magnetic resonance imaging (MRI), computed tomography of the head and cranial electrophysiological testing were performed. The first patient had severe right retroauricular pain during her menses for several years following Bell's palsy. Her brain MRI showed non-specific T2 white matter hyperintensities. On her electromyogram she had facial synkinesis with tonic motor unit discharges on her right orbicularis oris and mentalis muscles during sustained eye closure. The second patient reported hearing a sound over her left ear when she blinked or protruded her jaw after Bell's palsy. She had ipsilateral retroauricular pain, exacerbated during menses. Her brain MRI was normal. Electromyogram showed facial synkinesis. Chronic retroauricular pain, occurring or exacerbated during menses, may be a rare complication of Bell's palsy. It can be associated with facial subclinical synkinetic dystonia and trigemino-facial synkinesis.


2020 ◽  
Vol 26 (6) ◽  
pp. 455-461 ◽  
Author(s):  
Bin-yan Yu ◽  
Yan-ping Wang ◽  
Hong-cai Shang ◽  
Li-ying Wang ◽  
Yi-jia Wan ◽  
...  

1977 ◽  
Vol 86 (4) ◽  
pp. 549-558 ◽  
Author(s):  
Ruth Gussen

The pathogenesis of Bell's palsy is presented as retrograde epineurial compression edema with ischemia of the facial nerve. Although the etiology is unknown, an attractive theory is vasospasm, from any cause, along any facial nerve branch, with the chorda tympani, perhaps, the usual primary involvement. Retrograde vascular distension and edema, within the epineurium of the bony facial canal, compresses the nerve from outside its perineurial sheath. The compression force may be mild or severe, resulting in varying degrees of reversible or irreversible ischemic degeneration of myelin sheaths and axons, with varying degrees of cellular reaction to myelin breakdown. The edema may be resorbed, leaving reversible or irreversible nerve damage, or may stimulate collagen formation within the epineurium, with persisting fibrous compression (entrapment) neuropathy of the facial nerve. This concept is consistent with the varying results of Bell's palsy, and depends on the severity and duration of edema, and whether fibrosis occurs within the epineurium of the facial canal. Epineurial fibrosis also results in disturbance of metabolic exchange through the epineurial-permeurial-endoneurial tissues, and may ultimately result in obliteration of vascular drainage. Two temporal bone cases of Bell's palsy, one occurring ten years before death, with residual paralysis. and one two years before death, with clinical recovery, are added to the previously described four cases in the literature, three of early Bell's palsy, and one of remote palsy with almost complete recovery.


2003 ◽  
Vol 112 (3) ◽  
pp. 197-201 ◽  
Author(s):  
Sara Axelsson ◽  
Sven Lindberg ◽  
Anna Stjernquist-Desatnik

Idiopathic facial paralysis, or Bell's palsy, shows a nonepidemic pattern that might indicate reactivation of a latent microorganism such as herpes simplex type I as a causative agent. Thirty percent of patients with Bell's palsy given no treatment will not recover completely, and 5% will have severe sequelae. The aim of this study was to find out whether treatment with an antiviral drug in combination with corticosteroids is more effective than no medical treatment at all in patients with Bell's palsy. Fifty-six consecutive adult patients attending the otorhinolaryngology department of the University Hospital of Lund from 1997 to 1999 were treated with 1 g of valacyclovir hydrochloride 3 times per day for 7 days and 50 mg of prednisone daily for 5 days, with the dose being reduced by 10 mg daily for the next 5 days. Fifty-six adult patients with Bell's palsy attending the same department between 1995 and 1996 who were given no medical treatment were studied retrospectively and used as the control group. Forty-nine patients (87.5%) in the treatment group recovered completely, as compared with 38 patients (68%) in the control group (p <.05). One patient (1.8%) in the treatment group displayed severe sequelae, defined as a House-Brackmann score of IV or worse, as compared with 10 of 56 patients (18%) in the control group (p <.01). Among patients over 60 years old, 10 of 10 in the treatment group had complete recovery, as compared with 5 of 12 patients in the control group (p <.01). The present study showed a significantly better outcome in patients with Bell's palsy treated with valacyclovir and prednisone as compared with patients given no medical treatment. This difference in outcome was especially pronounced among elderly patients.


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