scholarly journals Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Kyoung-Ho Seo ◽  
Joonyoung Jang ◽  
Eun Gyeong Jang ◽  
Yulhyun Park ◽  
So Young Lee ◽  
...  
Keyword(s):  
Neuromuscular Electrical Stimulation ◽  
Oral Intake ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Double Blind ◽  
Registration Number ◽  
Md Anderson ◽  
Functional Oral Intake Scale ◽  
Anderson Dysphagia Inventory

Abstract Background To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles. Objective To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. Methods In this prospective randomized case–control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2–3 weeks (minimal session: 7 times, treatment duration: 300–800 min). Twelve subjects in the 4-channel NMES group and eleven subjects in the 2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale. Results The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores. Conclusions The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia. Trial registration: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1.

scholarly journals Effectiveness of the sequential 4-channel NMES compared with conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study

2020 ◽  
Author(s):  
Kyoung-Ho Seo ◽  
Joonyoung Jang ◽  
Eun Gyeong Jang ◽  
Yulhyun Park ◽  
So Young Lee ◽  
...  
Keyword(s):  
Neuromuscular Electrical Stimulation ◽  
Oral Intake ◽  
Controlled Study ◽  
Double Blind ◽  
Physical Scale ◽  
Registration Number ◽  
Md Anderson ◽  
Functional Oral Intake Scale ◽  
Anderson Dysphagia Inventory ◽  
Control Study

Abstract Background: To date, conventional swallowing therapies and 2-channel NMES are standard treatments for dysphagia. The precise mechanism of 2-channel neuromuscular electrical stimulation (NMES) treatment has yet to be determined, and controversy remains over the efficacy. The sequential 4-channel NMES was newly developed based on the normal contractile sequence of swallowing-related muscles. Objective: To evaluate and compare the rehabilitative effectiveness of sequential 4-channel NMES with that of conventional 2-channel NMES.Methods: In this prospective randomized case-control study, 23 subjects with dysphagia were enrolled. Twelve subjects with 4-channel NMES group and eleven subjects with 2-channel NMES group completed the intervention. Pretreatment and posttreatment evaluations were performed with the videofluoroscopic dysphagia scale (VDS), penetration-aspiration scale (PAS), MD Anderson dysphagia inventory (MDADI), functional oral intake scale (FOIS), and Likert scale.Results: The sequential 4-channel NMES group significantly improved the VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical scale) compared with pretreatment data. The 2-channel NMES group significantly improved the VDS (oral, pharyngeal, and total) and MDADI (emotional, physical scale), but not the PAS and FOIS compared with pretreatment data. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS.Conclusions: Sequential 4-channel NMES activating the suprahyoid, thyrohyoid, and other infrahyoid muscles with proper interval time can be a new effective treatment for dysphagia.Trial registration : clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1

Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study

2016 ◽  
Vol 76 (4) ◽  
pp. 666-672 ◽  
Author(s):  
Mads Ammitzbøll-Danielsen ◽  
Mikkel Østergaard ◽  
Viktoria Fana ◽  
Daniel Glinatsi ◽  
Uffe Møller Døhn ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Isotonic Saline ◽  
Group Versus ◽  
Controlled Study ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Patient Reported ◽  
Registration Number

ObjectiveThe aim of this study was to compare the efficacy of intramuscular versus ultrasound (US)-guided intratenosynovial glucocorticoid injection in providing disease control after 2, 4 and 12 weeks in patients with rheumatoid arthritis(RA) with tenosynovitis.MethodsFifty patients with RA and tenosynovitis were randomised into two double-blind groups: (A) ‘intramuscular group’, receiving intramuscular injection of betamethasone and US-guided intratenosynovial isotonic saline injection and (B) ‘intratenosynovial group’ receiving saline intramuscularly and US-guided intratenosynovial betamethasone injection. All patients were in stable disease-modifying anti-rheumatic drug treatment prior to and during the study. Patients were excluded, and considered non-responders, if any treatments were altered during the follow-up period. ‘US tenosynovitis remission’, defined as US tenosynovitis grey-scale score ≤1 and colour Doppler score=0, was assessed at week 4 (primary outcome), and weeks 2 and 12, using non-responder imputation for missing data.ResultsUS tenosynovitis remission at week 4 was achieved in 25% (6/24) in the ‘intramuscular group’ versus 64% (16/25) in the ‘intratenosynovial group’, that is, a difference of −39 percentage point (pp) (CI −65pp to −13pp), Fisher exact test p=0.001. Corresponding values for the ‘intramuscular group’ versus the ‘intratenosynovial group’ at 2 and 12 weeks were 21% (5/24) versus 48% (13/25), that is, a difference of −27pp (CI −53pp to −2pp), p=0.072 and 8% (2/24) versus 44% (11/25), that is, difference of −36pp (−58pp to −13pp), p=0.003. Most US, clinical and patient-reported scores improved more in the ‘intratenosynovial group’ at all follow-up visits.ConclusionsIn this randomised double-blind clinical trial, patients with RA and tenosynovitis responded significantly better to US-guided intratenosynovial glucocorticoid injection than to intramuscular glucocorticoid injection, both at 4 and 12 weeks follow-up.Trial registration numberEudraCT nr: 2013-003486-34.

Adaptation and Validation of the Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing: DIGEST-FEES

2021 ◽  
pp. 1-9
Author(s):  
Heather M. Starmer ◽  
Loni Arrese ◽  
Susan Langmore ◽  
Yifei Ma ◽  
Joseph Murray ◽  
...  
Keyword(s):  
Interrater Reliability ◽  
Rating Scale ◽  
Oral Intake ◽  
Weighted Kappa ◽  
Dynamic Imaging ◽  
Severity Scale ◽  
Endoscopic Evaluation ◽  
Md Anderson ◽  
Functional Oral Intake Scale ◽  
Anderson Dysphagia Inventory

Purpose While flexible endoscopic evaluation of swallowing (FEES) is a common clinical procedure used in the head and neck cancer (HNC) population, extant outcome measures for FEES such as bolus-level penetration–aspiration and residue scores are not well suited as global patient-level endpoint measures of dysphagia severity in cooperative group trials or clinical outcomes research. The Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) was initially developed and validated for use during videofluoroscopic evaluations as a way to grade safety, efficiency, and overall pharyngeal swallowing impairment. The purpose of this study was to adapt and validate DIGEST for use with FEES. Method A modified Delphi exercise was conducted for content validation, expert consensus, adaptation, and operationalization of DIGEST-FEES. Three blinded, expert raters then evaluated 100 de-identified post-HNC treatment FEES examinations. Intra- and interrater reliability were tested with quadratic weighted kappa. Criterion validity against the MD Anderson Dysphagia Inventory, Functional Oral Intake Scale, Secretion Severity Scale, and Yale Residue Rating Scale was assessed with Spearman correlation coefficients. Results Interrater reliability was almost perfect for overall DIGEST-FEES grade (κ w = 0.83) and safety grade (κ w = 0.86) and substantial for efficiency grade (κ w = 0.74). Intrarater reliability was excellent for all raters (0.9–0.91). Overall DIGEST-FEES grade correlated with MD Anderson Dysphagia Inventory ( r = −.43, p < .0001), Functional Oral Intake Scale ( r = −.43, p < .0001), Secretion Severity Scale ( r = .47, p < .0001), Yale Vallecular Residue ( r = .73, p < .0001), and Yale Pyriform Sinus Residue ( r = .65, p < .0001). Conclusion DIGEST-FEES is a valid and reliable scale to describe the severity of pharyngeal dysphagia in patients with HNC. Supplemental Material https://doi.org/10.23641/asha.14642787

scholarly journals Dexmedetomidine decreased the post‐thyroidectomy bleeding by reducing cough and emergence agitation – a randomized, double‐blind, controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sang Hun Kim ◽  
Yoo Seok Kim ◽  
Seongcheol Kim ◽  
Ki Tae Jung
Keyword(s):  
Postoperative Bleeding ◽  
Postoperative Hemorrhage ◽  
Controlled Study ◽  
Emergence Agitation ◽  
Double Blind ◽  
Extubation Time ◽  
Registration Number ◽  
Recovery From Anesthesia ◽  
Postanesthetic Care Unit ◽  
Group D

Abstract Background Bleeding after thyroidectomy occurs due to violent coughing during emergence. Dexmedetomidine is helpful for the smooth emergence and suppression of cough. The purpose of the present study was to compare the effects of dexmedetomidine on postoperative bleeding after thyroidectomy. Methods Randomized, double-blind, controlled trials were conducted in female patients (ASA I–II, aged 20 to 60 years). The patients were randomly allocated into two groups. Approximately 15 min before the end of the surgery, dexmedetomidine was administered (0.6 µg/kg/h) without a loading dose in group D (n = 69), and normal saline was administered in group S (n = 70) at the same infusion rate. Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), and recovery time were assessed during the administration of the study drugs and recovery from anesthesia. The amount of postoperative hemorrhage was measured for 3 days. Results Data from a total of 139 patients were analyzed. The incidence of severe cough was significantly lower in group D than in group S (4.3 % vs. 11.5 %, P = 0.022). The emergence agitation in the postanesthetic care unit was significantly lower in group D than in group S (P = 0.01). Postoperative bleeding was significantly lower in group D than in group S until the second postoperative day (P = 0.015). Conclusions Dexmedetomidine can be helpful in decreasing bleeding after thyroidectomy by reducing coughing and emergence agitation. Trial registration This study was registered at http://clinicaltrials.gov (registration number NCT02412150, 09/04/2015).

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

scholarly journals Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

2020 ◽  
Vol 8 (3) ◽  
pp. 182-193
Author(s):  
Yunliang Wang
Keyword(s):  
Ischemic Stroke ◽  
Olfactory Ensheathing Cells ◽  
Controlled Study ◽  
Cell Group ◽  
Placebo Control ◽  
Phase 2 ◽  
Double Blind ◽  
Assessment Scores ◽  
Ensheathing Cells

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

scholarly journals One Year Follow-up of a Randomized, Double-Blind, Placebo-Controlled Trial of Percutaneous Peripheral Nerve Stimulation for Chronic Neuropathic Pain Following Amputation

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Joshua M Rosenow ◽  
Christopher Gilmore ◽  
Brian M Ilfeld ◽  
Sean Li ◽  
Mehul J Desai ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Pain Interference ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Abstract INTRODUCTION Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve postamputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective 1-yr follow-up to assess durability of pain relief and functional improvements. METHODS Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve post-amputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective one-year follow-up to assess durability of pain relief and functional improvements. RESULTS A significantly greater proportion of subjects who completed the 12-mo visit reported = 50% pain relief on the BPI-SF (5/8, 63%; average pain relief = 73% among responders) compared to the placebo group at the time of crossover (0/14, 0%, P = .003; average pain relief = 23%). A majority of subjects also reported = 50% reductions in pain interference at 12 mo (5/8, 63%). Two of 13 (15%) subjects in the placebo group reported sustained improvements in pain interference (P = .06). Average reduction in pain interference among responders in the PNS group was 87%. CONCLUSION This work suggests that PNS delivered over 60 d may provide clinically significant and enduring pain relief, enabling improved function and potentially reducing the need for a permanently implanted system.

scholarly journals The influence of the infusion of ephedrine and phenylephrine on the hemodynamic stability after subarachnoid anesthesia in senior adults - a controlled randomized trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Miodrag Žunić ◽  
Nevenka Krčevski Škvarč ◽  
Mirt Kamenik
Keyword(s):  
Blood Pressure ◽  
Final Analysis ◽  
Controlled Study ◽  
Senior Adults ◽  
Hemodynamic Changes ◽  
Hemodynamic Stability ◽  
Double Blind ◽  
Registration Number ◽  
Phenylephrine Infusion ◽  
Orthopedic Patients

Abstract Background We studied the influence of ephedrine or phenylephrine infusion administered immediately after spinal anesthesia (SA) on hemodynamics in elderly orthopedic patients. Methods A prospective, randomized, double-blind, placebo-controlled study. After a subarachnoid injection of 15 mg of levobupivacaine, the participants received an infusion of either ephedrine 20 mg (E group), phenylephrine 250 mcg (P group) or saline (C group) within 30 min. We measured blood pressure, cardiac index (CI) and heart rate (HR) from 15 min before to 30 min after SA. Results Seventy patients were included in the final analysis. At the end of measurements, mean arterial pressure (MAP) decreased significantly after SA in comparison to the baseline value in the C group but was maintained in the P and E group, with no significant differences between the groups. CI decreased after SA in the C group, was maintained in the P group, and increased significantly in the E group with significant differences between the C and E group (p = 0.049) also between the P and E (p = 0.01) group at the end of measurements. HR decreased significantly after SA in the C and P group but was maintained in the E group, with significant differences between the P and E group (p = 0.033) at the end of measurements. Conclusions Hemodynamic changes after SA in elderly orthopedic patients can be prevented by an immediate infusion of phenylephrine or ephedrine. In addition to maintaining blood pressure, the ephedrine infusion also maintains HR and increases CI after SA. Trial registration ISRCTN registry with registration number ISRCTN44377602, retrospectively registered on 15 June 2017.

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