Zmpczm017000.11.09
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This pilot study assessed the efficacy of electromyogram (EMG)-triggered neuromuscular stimulation (EMG-stim) for improving arm function in acute stroke survivors. Nine subjects within 6 weeks of their first stroke were randomly assigned to an EMG-stim group or control group. The EMG-stim group received two 30-minute EMG-stim sessions per day during rehabilitation, while the control group received wrist strengthening exercises without EMG-stim. Subjects treated with EMG-stim showed significantly greater gains in Fugl-Meyer motor assessment scores and Functional Independence Measure scores compared to the control group, suggesting that EMG-stim enhances arm function in acute stroke survivors.
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The document summarizes evidence from studies on behavioral and physical treatments for migraine headaches. It finds that relaxation training, thermal biofeedback plus relaxation training, EMG biofeedback therapy, and cognitive-behavioral therapy led to statistically significant improvements in headache frequency and severity, with effect sizes ranging from moderate to large. Combining cognitive-behavioral therapy with thermal biofeedback produced more modest improvements. Studies of acupuncture for migraines showed mixed results, with some finding it more effective than sham treatments and others finding no difference compared to sham interventions.
ZMPCZM016000.11.20 TENS can reduce postoperative analgesic consumption.A meta...
TENS can reduce postoperative analgesic consumption according to a meta-analysis of 21 randomized controlled trials. The analysis found that TENS reduced overall analgesic use by 26.5% compared to placebo. For trials using strong, subnoxious TENS at adequate frequencies, analgesic consumption was reduced by 35.5% compared to 4.1% for trials without these optimal parameters. The difference between optimal and non-optimal TENS was statistically significant, indicating TENS can significantly reduce pain medication needs when administered optimally.
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This document summarizes research on the use of electrotherapy/electrical stimulation for pain management. It discusses two major theories for how electrotherapy relieves pain through gate control and opiate-mediated control. Research studies cited found electrotherapy effective at reducing pain and improving function for chronic musculoskeletal pain, low back pain, and post-operative knee pain. Meta-analyses showed significant decreases in pain from electrical nerve stimulation and reductions in analgesic consumption when using adequate stimulation parameters.
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This study examined the effects of different frequencies of transcutaneous electrical nerve stimulation (TENS) on postoperative opioid requirements. 100 women undergoing gynecological surgery received patient-controlled analgesia and were assigned to receive sham TENS, low-frequency TENS, high-frequency TENS, or mixed-frequency TENS. Mixed-frequency TENS provided the greatest opioid-sparing effect, decreasing morphine requirements by 53% compared to sham TENS. Low and high frequencies also decreased requirements by 32% and 35% respectively. All active TENS groups had shorter PCA therapy duration and less nausea, dizziness, and itching than the sham group.
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ZMPCZM019000.11.03 EMG based evaluation & therapy concept for pelvic floor Dy...
(1) EMG is used to directly measure pelvic floor muscle function and innervation for evaluating and treating dysfunctions like incontinence. (2) A 4-channel EMG system measures the pelvic floor and surrounding muscles during standardized tests to analyze coordination and identify issues. (3) Biofeedback training then focuses on re-educating the pelvic floor muscle through isolated activation exercises and integrating it into whole body movements and daily activities. (4) Retests assess changes in muscle activation, endurance, and coordination from the training.
ZMPCZM016000.13.03 Certificate of compliance
The Certificate of Compliance certifies that the Zynex Medical NexWave TENS unit was tested and found to comply with IEC 60601-1 and IEC 60601-2-10 standards. The NexWave is a portable TENS unit that can be powered by an internal battery or external power supply and has two independent stimulation channels to apply electrical stimulation to skin sites via electrode pads. Compliance testing was performed by Compliance Integrity Services and the NexWave was
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The document discusses failure mode and effects analysis (FMEA) of engine systems to identify potential failures, analyze their causes and effects, and determine corrective actions to improve reliability. It provides details on conducting a DFMEA, including assembling a cross-functional team, documenting functions and potential failure modes, analyzing severity, occurrence, and detection of failures, and calculating a risk priority number. The goal is to iteratively conduct the DFMEA, take corrective actions, and reduce the risk priority numbers to design more reliable engine components and systems.
FDA Design Controls: What Medical Device Makers Need to Know
The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.
Systems Engineering and Requirements Management in Medical Device Product Dev...
Systems engineering is an interdisciplinary approach that focuses on defining customer needs, documenting requirements, and enabling the realization of successful systems. It considers both business and technical needs across the entire life cycle from concept to disposal. Requirements management is the foundation of systems engineering. Organizations can improve processes and reduce risks through structured approaches like the Systems Engineering V-Model and maturity models like CMMI that provide standard processes and best practices. Verification and validation are used to ensure a system meets its requirements through methods like testing, analysis and demonstration.
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ZMPCZM019000.11.04 Evidenced based guidelines for Migrane Headache : Behaviou...
ZMPCZM019000.11.04 Evidenced based guidelines for Migrane Headache : Behaviou...
ZMPCZM016000.11.20 TENS can reduce postoperative analgesic consumption.A meta...
ZMPCZM016000.11.20 TENS can reduce postoperative analgesic consumption.A meta...
ZMPCZM016000.11.23 Electrotherapy for pain management
ZMPCZM016000.11.23 Electrotherapy for pain management
ZMPCZM016000.11.22 effect of the frequency of TENS on the postoperative opio...
ZMPCZM016000.11.22 effect of the frequency of TENS on the postoperative opio...
ZMPCZM019000.11.03 EMG based evaluation & therapy concept for pelvic floor Dy...
ZMPCZM019000.11.03 EMG based evaluation & therapy concept for pelvic floor Dy...
FDA Design Controls: What Medical Device Makers Need to Know
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Transcranial Magnetic Stimulation ( TMS) for Chronic Pain
Aula sobre avanço no tratamento da dor crônica com o uso de Estimulação Magnética Transcraniana (EMT) ministrada por Dr. Rafael Higashi, médico neurologista, no departamento de tratamento da dor do Centro Médico da Universidade de Nova York, NYU, EUA.
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New microsoft office word document
The document discusses three studies that examined the effects of multimodal early onset stimulation (MEOS) therapy in patients and rats with severe brain injuries. The studies found that MEOS therapy combined with an enriched environment:
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Electromyographic activity of selected trunk muscles in subjects
This study evaluated electromyographic activity in trunk muscles of hemiparetic subjects and healthy controls during therapeutic exercises. The following were found:
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ZMPCZM017000.11.03
This study investigated the effects of intensive neuromuscular electrical stimulation (NMES) treatment at home over 3 weeks on functional improvements and cortical changes in subjects with chronic stroke. 16 subjects were randomly assigned to either a true NMES treatment group or a sham treatment group. Both groups underwent testing before and after treatment, and the sham group was also tested after crossing over to the true treatment. The true NMES group showed improvements in measures of hand function and strength, while the sham group did not improve initially but did improve after crossing over to true treatment. Functional MRI revealed increased cortical activation in the ipsilateral somatosensory cortex following true NMES treatment. This suggests NMES may stimulate cortical sensory areas to enable improved motor function
ZMPCZM017000.11.03
This study investigated the effects of intensive neuromuscular electrical stimulation (NMES) treatment at home over 3 weeks on functional improvements and cortical changes in subjects with chronic stroke. 16 subjects were randomly assigned to either a true NMES treatment group or a sham treatment group. Both groups underwent testing before and after treatment, and the sham group was also tested after crossing over to the true treatment. The NMES group demonstrated improvements in hand function tests and self-reported use scales not seen in the sham group. Additionally, NMES was found to increase cortical activation in the ipsilateral somatosensory cortex as measured by fMRI. The findings suggest NMES may stimulate cortical sensory areas to enable improved motor function in subjects with chronic stroke
ZMPCZM017000.11.03 Carey Experimentation on brain research
This study investigated the effects of intensive neuromuscular electrical stimulation (NMES) treatment at home over 3 weeks on functional improvements and cortical changes in subjects with chronic stroke. 16 subjects were randomly assigned to either a true NMES treatment group or a sham treatment group. Both groups underwent testing before and after treatment, and the sham group was also tested after crossing over to the true treatment. The true NMES group showed improvements in measures of hand function and strength, while the sham group did not improve initially but did improve after crossing over. Functional MRI revealed increased cortical activation in the ipsilateral somatosensory cortex following true NMES treatment. The findings suggest NMES may stimulate cortical sensory areas to enable improved motor function in subjects
Stroke Rehabilitation :Physiotherapy
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The document summarizes a randomized controlled trial that assessed the effectiveness of arm ergometer training for improving spasticity, range of motion, and motor control in patients with sub-acute and chronic stroke. 40 patients were divided into two groups - one that received conventional therapy alone and one that received conventional therapy plus arm ergometer training. The results showed that the group receiving arm ergometer training in addition to conventional therapy had significantly greater reductions in spasticity, as well as greater improvements in range of motion and gross motor function compared to the conventional therapy alone group. The study concluded that conventional therapy combined with arm ergometer treatment was effective for reducing spasticity and improving motor outcomes in sub-acute and chronic strokeZMPCZM017000.11.11
This study examined the feasibility and efficacy of home-based electromyography-triggered neuromuscular stimulation (ETMS) for chronic stroke patients with limited wrist extension ability. Twelve chronic stroke patients were randomly assigned to receive either 8 weeks of ETMS followed by 8 weeks of home exercises, or vice versa. Outcome measures included the Fugl-Meyer assessment, Action Research Arm Test, and goniometry. After ETMS, patients showed modest improvements on the Fugl-Meyer but no changes on the Action Research Arm Test. Both groups increased active wrist extension by 21 degrees after ETMS. The study demonstrated ETMS can be feasibly administered at home and can increase active wrist movement, though it did
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Reduced Short- and Long-Latency Afferent Inhibition Following Acute Muscle Pa...
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Nikos Malliaropoulos - Rehabilitation of hamstring injuries
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This article reviews recent literature on the application of transcutaneous electrical nerve stimulation (TENS) for pain management. Several studies have found TENS to be effective for acute postoperative pain, reducing medication needs and facilitating earlier recovery. TENS placed near surgical incisions reduced pain and medication requirements after procedures like laparotomy, cholecystectomy, and laminectomy. TENS may also benefit rehabilitation after knee surgery by reducing pain and narcotic use, allowing for earlier quadriceps strengthening and range of motion. While specific stimulation settings do not seem to impact outcomes, proper electrode placement is important. Overall, TENS is an effective non-pharmacological option for acute pain that facilitates recovery after surgery and injury.
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This article reviews recent literature on the use of transcutaneous electrical nerve stimulation (TENS) to manage acute and chronic pain. For acute pain, TENS has been shown to reduce postoperative pain and medication use when electrodes are placed near incisions and used continuously for 48-72 hours. Studies of TENS for acute dental pain and labor also found it provided pain relief. Treatment outcomes are evaluated using subjective pain ratings and objective measures like pulmonary function and range of motion. While TENS provides pain relief for many acute conditions, its effectiveness for chronic pain varies more between individuals. More research is needed to determine which chronic pain patients respond best to TENS.
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This study examined the analgesic effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) on heat pain thresholds in healthy subjects. 48 subjects were randomly assigned to receive either TENS, IFC, or no stimulation for 30 minutes. Heat pain thresholds were measured before, during, and after stimulation. Both TENS and IFC significantly increased heat pain thresholds during stimulation compared to no stimulation. While the effect of TENS did not last long after stimulation, IFC maintained elevated heat pain thresholds for at least 30 minutes following stimulation. The study concluded that both TENS and IFC can effectively reduce heat pain sensitivity in healthy subjects, with IFC having longer-lasting effects.
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This clinical trial investigated whether neuromuscular electrical stimulation (NMES) could improve quadriceps muscle strength and activation in women with mild to moderate osteoarthritis of the knee. Thirty women were randomly assigned to either receive NMES treatments 3 times per week for 4 weeks or to a control group that received no treatment. Outcomes were assessed at baseline and 5 and 16 weeks post-enrollment and found no improvements in muscle strength or activation in the NMES group compared to controls. The study was limited by a small sample size and lack of blinding, suggesting further research is needed to determine an effective dosage of NMES for this population.
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This clinical trial investigated whether neuromuscular electrical stimulation (NMES) could improve quadriceps muscle strength and activation in women with mild to moderate osteoarthritis of the knee. Thirty women were randomly assigned to either receive NMES treatments three times per week for four weeks or to a control group that received no treatment. Outcomes were assessed at baseline and at 5 and 16 weeks post-enrollment and found no improvements in muscle strength or activation in the NMES group compared to controls. The study was limited by a small sample size and lack of blinding of the assessor and participants to group assignment. Four weeks of NMES may have been insufficient to induce gains in this population and future research is needed to examine longer or more
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Zmpczm017000.11.09
- 1. ELECTROMYOGRAM-TRIGGERED NEUROMUSCULAR STIMULATION FOR IMPROVING THE ARM FUNCTION OF ACUTE STROKE SURVIVORS: A RANDOMIZED PILOT STUDY Gerard Francisco, MD, Jon Chae, MD, ME, Harmeen Chawla, MD, Steven Kirshblum, MD, Richard Zorowitz, MD, Gerald Lewis, MS, PT, Shcone Pang, MS, OTR. Arch. Phys. Med. Published in Rehabil 1998; 79:570-575 Summary: Objective: To assess the efficacy of electromyogram (EMG)-triggered neuromuscular stimulation (EMG-stim) in enhancing upper extremity motor and functional recovery of acute stroke survivors. Design: A pilot randomized, single-blinded clinical trial. Setting: Freestanding inpatient rehabilitation facility. Patients: Nine subjects who were within 6 weeks of their first unifocal. nonhemorrhagic stroke were randomly assigned to either the EMG-stim (n=4) or control (n=5) group. All subjects had a detectable EMG signal (>5?V) from the surface of the paretic extensor carpi radialis and voluntary wrist of the paretic extensor carpi radialis and voluntary wrist extension in synergy or in isolation with muscle grade of <3/5. Intervention: All subjects received two 30-minute sessions per say of wrist strengthening exercises with EMG-stim (experimental) or without (control) for the duration of their rehabilitation stay. Main Outcome Measures: Upper extremity Fugl-Meyer motor assessment and the feeding, grooming, and upper body dressing items of the Functional Independence Measure (FIM) were assessed at study entry and at discharge. Results: Subjects treated with EMG-stim exhibited significantly greater gains in Fugl-Meyer (27.0 vs 10.4; p=.05), and FIM (6.0 vs 3.4: p=.02) scores compared with controls. Conclusion: Data suggest that EMG-stim enhances the arm function of acute stroke survivors