Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study

BACKGROUND Fecal incontinence(FI)is an involuntary passage of fecal matter which can have a significant impact on a patient’s quality of life.Many modalities of treatment exist for FI.Sacral nerve stimulation is a well-established treatment for FI.Given the increased need of magnetic resonance imaging(MRI)for diagnostics,the In-terStim which was previously used in sacral nerve stimulation was limited by MRI incompatibility.Medtronic MRI-compatible InterStim was approved by the United States Food and Drug Administration in August 2020 and has been widely used.AIM To evaluate the efficacy,outcomes and complications of the MRI-compatible InterStim.METHODS Data of patients who underwent MRI-compatible Medtronic InterStim placement at UPMC Williamsport,University of Minnesota,Advocate Lutheran General Hospital,and University of Wisconsin-Madison was pooled and analyzed.Patient demographics,clinical features,surgical techniques,complications,and outcomes were analyzed.Strengthening the Reporting of Observational studies in Epidemiology(STROBE)cross-sectional reporting guidelines were used.RESULTS Seventy-three patients had the InterStim implanted.The mean age was 63.29±12.2 years.Fifty-seven(78.1%)patients were females and forty-two(57.5%)patients had diabetes.In addition to incontinence,overlapping symptoms included diarrhea(23.3%),fecal urgency(58.9%),and urinary incontinence(28.8%).Fifteen(20.5%)patients underwent Peripheral Nerve Evaluation before proceeding to definite implant placement.Thirty-two(43.8%)patients underwent rechargeable InterStim placement.Three(4.1%)patients needed removal of the implant.Migration of the external lead connection was observed in 7(9.6%)patients after the stage I procedure.The explanation for one patient was due to infection.Seven(9.6%)patients had other complications like nerve pain,hematoma,infection,lead fracture,and bleeding.The mean follow-up was 6.62±3.5 mo.Sixty-eight(93.2%)patients reported significant improvement of symptoms on follow-up evaluation.CONCLUSION This study shows promising results with significant symptom improvement,good efficacy and good patient outcomes with low complication rates while using MRI compatible InterStim for FI.Further long-term follow-up and future studies with a larger patient population is recommended.

GTCS-Vagus Nerve Stimulator Automation Using Private IoT-Blockchain Smartcontract

Generalized Tonic Clonic Seizure(GTCS)is a form of epileptic seizure in which a patient loses control over their entire body,ultimately leading to loss of consciousness.The Vagus Nerve Stimulator(VNS)is a tool/method for treating epileptic episodes that sends counter-electrical stimulations to the Vagus Nerve in order to mitigate epileptic signals from the brain.The machine is a stand-alone device that depends on human decision-making.The proposed framework uses an IoT and Blockchain oversight mechanism to augment the device's transparency.The system counteracts against false-activation by monitoring the patient's vitals through a smart watch and allows only legitimate use.The nominal operating threshold is determined by preprocessing inferences that include an 18-year-old GTCS epileptic patient and a data set of 281 non-GTCS epileptic patients.The proposed system functions as a dual control lock where the IoT system and the manually activation system work in tandem to activate the device.Based on the values sensed by the IoT device,the deployed system is able to make deci-sions and regulate the use of the VNS.The IoT-Blockchain framework is able to fully eradicate false activation by increasing accuracy and transparency,ensur-ing the device is used correctly and safely.

Pain management using Han’s acupoint nerve stimulator combined with patient-controlled analgesia following neurosurgery A randomized case control study

BACKGROUND： Han＇s acupoint nerve stimulator （HANS） has been frequently used to relieve pain by promoting the central nerve system＇s release of endogenous opioid peptides through electric stimulation to the body surface. OBJECTIVE： To investigate the pain-relieving effects of HANS, combined with patient-controlled analgesia, following neurosurgery, and to observe adverse reactions and effects. DESIGN, TIME AND SETTING： A randomized control observation was performed at the Department of Neurology in the First Affiliated Hospital of Gannan Medical College （Ganzhou, Jiangxi Province, China） from January 2005 to February 2006. PARTICIPANTS： Forty patients, who were selected for craniotomy and required pain relief following surgery at the Department of Neurology in the First Affiliated Hospital of Gannan Medical College （China）, were included in this study. METHODS： Forty patients underwent neurosurgery and were randomly divided into two groups： patient-controlled analgesia plus HANS （＋HANS, n = 20） and patient-controlled analgesia （-HANS, n = 20）. Both groups were well matched in baseline data. Automatic syringe infusion pump ZZB-150 was the product of Nantong Aipeng Medical Instruments Co., Ltd. （China）. Patient-controlled analgesia consisted of 100 mL 0.02% lappaconitine/0.02% metoclopramide. LH-402 HANS instrument was produced in Beijing （China）, with a serial number of 402183. The HANS instrumentation was used to stimulate the Hegu-Laogong acupoint on one side and Jiaogan, Shenmen penetrating Shen, Waifei, Naogan penetrating Pizhixia ear acupoints on the affected side for one hour, with 2-hour intervals. The disperse-dense wave was alternating, with a 2/100 Hz frequency of electrical stimulation. MAIN OUTCOME MEASURE： The scores of visual analogue scale and incidence of adverse reaction were observed in two groups following surgery. RESULTS： Compared with the HANS group, the visual analogue scale scores were remarkably lower in the ＋HANS group six hours after surgery （P 〈 0.01）, and the incidence rate of adverse reactions, such as nausea and vomiting, was also decreased （P 〈 0.05）.CONCLUSION： The application of HANS to induce body surface stimulation can enhance the effect of pain relief and reduce adverse reactions when used in combination with patient-controlled analgesia following neurosurgery. The effect of combined therapy is superior to patient-controlled analgesia alone.

Vagus nerve stimulation in cerebral stroke:biological mechanisms,therapeutic modalities,clinical applications,and future directions

Stroke is a major disorder of the central nervous system that poses a serious threat to human life and quality of life.Many stro ke victims are left with long-term neurological dysfunction,which adversely affects the well-being of the individual and the broader socioeconomic impact.Currently,poststroke brain dysfunction is a major and difficult area of treatment.Vagus nerve stimulation is a Food and Drug Administration-approved exploratory treatment option for autis m,refractory depression,epilepsy,and Alzheimer’s disease.It is expected to be a novel therapeutic technique for the treatment of stroke owing to its association with multiple mechanisms such as alte ring neurotransmitters and the plasticity of central neuro ns.In animal models of acute ischemic stroke,vagus nerve stimulation has been shown to reduce infarct size,reduce post-stroke neurological damage,and improve learning and memory capacity in rats with stroke by reducing the inflammatory response,regulating bloodbrain barrier permeability,and promoting angiogenesis and neurogenesis.At present,vagus nerve stimulation includes both invasive and non-invasive vagus nerve stimulation.Clinical studies have found that invasive vagus nerve stimulation combined with rehabilitation therapy is effective in im proving upper limb motor and cognitive abilities in stroke patients.Further clinical studies have shown that non-invasive vagus nerve stimulation,including ear/ce rvical vagus nerve stimulation,can stimulate vagal projections to the central nervous system similarly to invasive vagus nerve stimulation and can have the same effect.In this paper,we first describe the multiple effects of vagus nerve stimulation in stroke,and then discuss in depth its neuroprotective mechanisms in ischemic stroke.We go on to outline the res ults of the current major clinical applications of invasive and non-invasive vagus nerve stimulation.Finally,we provide a more comprehensive evaluation of the advantages and disadvantages of different types of vagus nerve stimulation in the treatment of cerebral ischemia and provide an outlook on the developmental trends.We believe that vagus nerve stimulation,as an effective treatment for stroke,will be widely used in clinical practice to promote the recovery of stroke patients and reduce the incidence of disability.

Millimetric devices for nerve stimulation:a promising path towards miniaturization

Nerve stimulation is a rapidly developing field,demonstrating positive outcomes across several conditions.Despite potential benefits,current nerve stimulation devices are large,complicated,and are powered via implanted pulse generators.These facto rs necessitate invasive surgical implantation and limit potential applications.Reducing nerve stimulation devices to millimetric sizes would make these interventions less invasive and facilitate broader therapeutic applications.However,device miniaturization presents a serious engineering challenge.This review presents significant advancements from several groups that have overcome this challenge and developed millimetricsized nerve stimulation devices.These are based on antennas,mini-coils,magneto-electric and optoelectronic materials,or receive ultrasound power.We highlight key design elements,findings from pilot studies,and present several considerations for future applications of these devices.

Ultrasound guidance for brachial plexus block decreases the incidence of complete hemi-diaphragmatic paresis or vascular punctures and improves success rate of brachial plexus nerve block compared with peripheral nerve stimulator in adults

Background The use of traditional techniques （such as landmark techniques, paresthesia and peripheral nerve stimulator） for upper-limb anesthesia has often been restricted to the expert or enthusiast, which was blind. Recently, ultrasound （US） has been applied to differ blood vessel, pleura and nerve, thus may reduce the risk of complications while have a high rate of success. The aim of this study was to determine if the use of ultrasound guidance （vs. peripheral nerve stimulator, （PNS）） decreases risk of vascular puncture, risk of hemi-diaphragmatic paresis and risk of Homer syndrome and improves the success rate of nerve block. Methods A search strategy was developed to identify randomized control trials （RCTs） reporting on complications of US and PNS guidance for upper-extremity peripheral nerve blocks （brachial plexus） in adults available through PubMed databases, the Cochrane Central Register of Controlled Trials, Embase databases, SinoMed databases and Wanfang data （date up to 2011-12-20）. Two independent reviewers appraised eligible studies and extracted data. Risk ratios （OR） were calculated for each outcome and presented with 95% confidence intervals （CI） with the software of Review Manager 5.1.0 System （Cochrane Library）. Results Sixteen trials involving 1321 adults met our criteria were included for analysis. Blocks performed using US guidance were more likely to be successful （risk ratio （RR） for block success 0.36, 95% CI 0.23-0.56, P 〈0.00001）, decreased incidence of vascular puncture during block performance （RR 0.13, 95% CI 0.06-0.27, P 〈0.00001）, decreased the risk of complete hemi-diaphragmatic paresis （RR 0.09, 95% CI 0.03-0.52, P=-0.0001）. Conclusions US decreases risks of complete hemi-diaphragmatic paresis or vascular puncture and improves success rate of brachial plexus nerve block compared with techniques that utilize PNS for nerve localization. Larger studies are needed to determine whether or not the use of US can decrease risk of neurologic complications.

Predictors of success in hypoglossal nerve stimulator implantation for obstructive sleep apnea

Objective:Current guidelines for hypoglossal nerve stimulator(HGNS)implantation eligibility include drug-induced sleep endoscopy(DISE)findings and other patient characteristics but lead to highly variable rates of surgical success across institutions.Our objective was to determine whether additional factors seen on preoperative evaluation could be used as predictors of surgical success.Study design:Retrospective chart review.Setting:Single-institution academic tertiary care medical center.Subjects:and Methods:This study included patients with obstructive sleep apnea(OSA)who underwent HGNS implantation between 2015 and 2018.Surgical success was defined as a post-operative apnea-hypopnea index(AHI)of less than 20 events per hour and an AHI reduction of at least 50%.Preoperative polysomnogram(PSG)results,DISE findings,and physical parameters were compared between surgical successes and failures.Results:A total of 68 patients were included in the analysis.The overall surgical success rate was 79.4%(54/68).Elevated preoperative AHI was associated with an increased likelihood of treatment failure,with an AHI of(36.9±16.8)events/hour in the success group compared to(49.4±19.6)events/hour in the failure group(P=0.05).Patients observed to have partial lateral oropharyngeal collapse on DISE was more frequently associated with the treatment failure group than in the success group(P=0.04).Conclusion:Patients who underwent HGNS implantation overall had a very high treatment response rate at our institution.Factors that may predispose patients to surgical failure included the presence of lateral oropharyngeal collapse and a significantly elevated preoperative AHI.These should be considered when determining surgical candidacy for HGNS implantation.

An ultrasound-guided percutaneous electrical nerve stimulation regimen devised using finite element modeling promotes functional recovery after median nerve transection

Percutaneous electrical nerve stimulation of an injured nerve can promote and accelerate peripheral nerve regeneration and improve function.When performing acupuncture and moxibustion,locating the injured nerve using ultrasound before percutaneous nerve stimulation can help prevent further injury to an already injured nerve.However,stimulation parameters have not been standardized.In this study,we constructed a multi-layer human forearm model using finite element modeling.Taking current density and activated function as optimization indicators,the optimal percutaneous nerve stimulation parameters were established.The optimal parameters were parallel placement located 3 cm apart with the injury site at the midpoint between the needles.To validate the efficacy of this regimen,we performed a randomized controlled trial in 23 patients with median nerve transection who underwent neurorrhaphy.Patients who received conventional rehabilitation combined with percutaneous electrical nerve stimulation experienced greater improvement in sensory function,motor function,and grip strength than those who received conventional rehabilitation combined with transcutaneous electrical nerve stimulation.These findings suggest that the percutaneous electrical nerve stimulation regimen established in this study can improve global median nerve function in patients with median nerve transection.

Vagus nerve stimulation is a potential treatment for ischemic stroke

Microglia are the brain’s primary innate immune cells,and they are activated and affect pro-inflammatory phenotype or regulatory phenotype after ischemic stroke.Vagus nerve stimulation was shown to activate microglial phenotypic changes and exhibit neuroprotective effects in ischemia/reperfusion injury.In this study,we established rat models of ischemic stroke by occlusion of the middle cerebral artery and performed vagus nerve stimulation 30 minutes after modeling.We found that vagus nerve stimulation caused a shift from a pro-inflammatory phenotype to a regulatory phenotype in microglia in the ischemic penumbra.Vagus nerve stimulation decreased the levels of pro-inflammatory phenotype markers inducible nitric oxide synthase and tumor necrosis factorαand increased the expression of regulatory phenotype markers arginase 1 and transforming growth factorβthrough activatingα7 nicotinic acetylcholine receptor expression.Additionally,α7 nicotinic acetylcholine receptor blockade reduced the inhibition of Toll-like receptor 4/nuclear factor kappa-B pathwayassociated proteins,including Toll-like receptor 4,myeloid differentiation factor 88,I kappa B alpha,and phosphorylated-I kappa B alpha,and also weakened the neuroprotective effects of vagus nerve stimulation in ischemic stroke.Vagus nerve stimulation inhibited Toll-like receptor 4/nuclear factor kappa-B expression through activatingα7 nicotinic acetylcholine receptor and regulated microglial polarization after ischemic stroke,thereby playing a role in the treatment of ischemic stroke.Findings from this study confirm the mechanism underlying vagus nerve stimulation against ischemic stroke.

Vagus nerve stimulation protects against cerebral injury after cardiopulmonary resuscitation by inhibiting inflammation through the TLR4/NF-κB and α7nAChR/JAK2 signaling pathways

BACKGROUND: Our previous research proved that vagus nerve stimulation(VNS) improved the neurological outcome after cardiopulmonary resuscitation(CPR) by activating α7 nicotinic acetylcholine receptor(α7nAChR) in a rat model, but the underlying mechanism of VNS in neuroprotection after CPR remains unclear.METHODS: In vivo, we established a mouse model of cardiac arrest(CA)/CPR to observe the survival rate, and the changes in inflammatory factors and brain tissue after VNS treatment. In vitro, we examined the effects of α7nAChR agonist on ischemia/reperfusion(I/R)-induced inflammation in BV2 cells under oxygen-glucose deprivation/reoxygenation(OGD/R) conditions. We observed the changes in cell survival rate, the levels of inflammatory factors, and the expressions of α7nAChR/Janus kinase 2(JAK2) and toll-like receptor 4(TLR4)/nuclear factor-κB(NF-κB).RESULTS: In vivo, VNS preconditioning enhanced functional recovery, improved the survival rate, and reduced hippocampal CA1 cell damage, and the levels of inflammatory mediators after CA/CPR. The application of α7nAChR agonists provided similar effects against cerebral injury after the return of spontaneous circulation(ROSC), while α7nAChR antagonists reversed these neuroprotective impacts. The in vitro results mostly matched the findings in vivo. OGD/R increased the expression of tumor necrosis factor-alpha(TNF-α), TLR4 and NF-κB p65. When nicotine was added to the OGD/R model, the expression of TLR4, NF-κB p65, and TNF-α decreased, while the phosphorylation of JAK2 increased, which was prevented by preconditioning with α7nAChR or JAK2 antagonists.CONCLUSION: The neuroprotective effect of VNS correlated with the activation of α7nAChR. VNS may alleviate cerebral IR injury by inhibiting TLR4/NF-κB and activating the α7nAChR/JAK2 signaling pathway.

Advances of Research on Auricular Vagus Nerve Stimulation for Treatment of Nervous System Diseases

As a new type of nerve regulation technology, Vagus Nerve Stimulation is currently used in the treatment of nervous system diseases. Auricular Vagus Nerve Stimulation has become one of the research hotspots in this field, because there is no implantation risk. However, there is no unified standard for the treatment parameters of aVNS for nervous system diseases. In this paper, the research progress of the anatomical structure and parameters of the vagus nerve and its role in nervous system diseases are reviewed to provide basis for further research.

A Spiral History of the Development of Ways to Identify the Correct Position of the Injection Needle in Relation to the Peripheral Nerve: A Brief Historical Essay

The first way to identify the needle in relation to the peripheral nerve W. Halsted and R. Hall in 1884 performed the first regional blockade (using direct visualization). However, Vassily von Anrep was a few months earlier described the blockade of the peripheral nerve by anatomical landmarks. In 1912, the blockade of the brachial plexus was first performed using electrical stimulation, but this technique has been widely used only since 1962. The most popular way to identify the needle relative to the nerve at the moment remains US guidance. A promising direction may be optical coherence tomography. But this method is under development. In the last decade, a method for determining the pressure of a local anesthetic has been introduced into practice to determine the position of the needle relative to the nerve.

Electrical stimulation of the vagus nerve protects against cerebral ischemic injury through an anti-inflammatory mechanism

Vagus nerve stimulation exerts protective effects against ischemic brain injury; however, the underlying mechanisms remain unclear. In this study, a rat model of focal cerebral ischemia was established using the occlusion method, and the right vagus nerve was given electrical stimula-tion （constant current of 0.5 mA; pulse width, 0.5 ms; frequency, 20 Hz; duration, 30 seconds; every 5 minutes for a total of 60 minutes） 30 minutes, 12 hours, and 1, 2, 3, 7 and 14 days after surgery. Electrical stimulation of the vagus nerve substantially reduced infarct volume, improved neurological function, and decreased the expression levels of tumor necrosis factor-α and in-terleukin-6 in rats with focal cerebral ischemia. The experimental findings indicate that the neuroprotective effect of vagus nerve stimulation following cerebral ischemia may be associated with the inhibition of tumor necrosis factor-α and interleukin-6 expression.

Wake-promoting effects of vagus nerve stimulation after traumatic brain injury: upregulation of orexin-A and orexin receptor type 1 expression in the prefrontal cortex

Orexins, produced in the lateral hypothalamus, are important neuropeptides that participate in the sleep/wake cycle, and their expres- sion coincides with the projection area of the vagus nerve in the brain. Vagus nerve stimulation has been shown to decrease the amounts of daytime sleep and rapid eye movement in epilepsy patients with traumatic brain injury. In the present study, we investigated whether vagus nerve stimulation promotes wakefulness and affects orexin expression. A rat model of traumatic brain injury was established using the free fall drop method. In the stimulated group, rats with traumatic brain injury received vagus nerve stimulation （frequency, 30 Hz, current, 1.0 mA; pulse width, 0.5 ms; total stimulation time, 15 minutes）. In the antagonist group, rats with traumatic brain injury were intracerebroventricularly injected with the orexin receptor type 1 （OXIR） antagonist SB334867 and received vagus nerve stimulation. Changes in consciousness were observed after stimulation in each group. Enzyme-linked immunosorbent assay, western blot assay and immunohistochemistry were used to assess the levels of orexin-A and OX1R expression in the prefrontal cortex. In the stimulated group, consciousness was substantially improved, orexin-A protein expression gradually increased within 24 hours after injury and OX1R expres- sion reached a peak at 12 hours, compared with rats subjected to traumatic brain injury only. In the antagonist group, the wake-promoting effect of vagus nerve stimulation was diminished, and orexin-A and OX1R expression were decreased, compared with that of the stim- ulated group. Taken together, our findings suggest that vagus nerve stimulation promotes the recovery of consciousness in comatose rats after traumatic brain injury. The upregulation of orexin-A and OXIR expression in the prefrontal cortex might be involved in the wake-promoting effects of vagus nerve stimulation.

Resuscitation therapy for traumatic brain injuryinduced coma in rats:mechanisms of median nerve electrical stimulation

In this study, rats were put into traumatic brain injury-induced coma and treated with median nerve electrical stimulation. We explored the wake-promoting effect, and possible mechanisms, of median nerve electrical stimulation. Electrical stimulation upregulated the expression levels of orexin-A and its receptor OX1R in the rat prefrontal cortex. Orexin-A expression gradually in-creased with increasing stimulation, while OX1R expression reached a peak at 12 hours and then decreased. In addition, after the OX1R antagonist, SB334867, was injected into the brain of rats after traumatic brain injury, fewer rats were restored to consciousness, and orexin-A and OXIR expression in the prefrontal cortex was downregulated. Our ifndings indicate that median nerve electrical stimulation induced an up-regulation of orexin-A and OX1R expression in the pre-frontal cortex of traumatic brain injury-induced coma rats, which may be a potential mechanism involved in the wake-promoting effects of median nerve electrical stimulation.

Efficacy and safety of transcutaneous auricular vagus nerve stimulation combined with conventional rehabilitation training in acute stroke patients: a randomized controlled trial conducted for 1 year involving 60 patients

Transcutaneous auricular vagus nerve stimulation(ta-VNS)is a novel noninvasive treat-ment for stroke that directly stimulates the peripheral auricular branch of the vagus nerve.There have been recent reports that ta-VNS combined with conventional rehabilitation training promotes the recovery of neurological function of patients with acute stroke.However,these were small-sample-sized studies on the recovery of neurological function in patients after percutaneous vagus nerve stimulation in the subacute and chronic phases after stroke.This double-blinded randomized controlled trial involved 60 acute ischemic or hemorrhagic stroke patients aged 18-80 years who received treatment in the Second Affiliated Hospital of Chongqing Medical University.The subjects were randomly assigned to receive ta-VNS or sham ta-VNS combined with conventional rehabilitation training.The follow-up results over 1 year revealed that ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses compared with sham ta-VNS combined with conventional rehabilitation training.There were no obvious side effects.These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or hemorrhagic stroke patients is safe and effective.

Neuroprotective effects of vagus nerve stimulation on traumatic brain injury

Previous studies have shown that vagus nerve stimulation can improve the prognosis of trau- matic brain injury. The aim of this study was to elucidate the mechanism of the neuroprotective effects of vagus nerve stimulation in rabbits with brain explosive injury. Rabbits with brain ex- plosive injury received continuous stimulation （10 V, 5 Hz, 5 ms, 20 minutes） of the right cervical vagus nerve. Tumor necrosis factor-a, interleukin-l~ and interleukin-10 concentrations were detected in serum and brain tissues, and water content in brain tissues was measured. Results showed that vagus nerve stimulation could reduce the degree of brain edema, decrease tumor necrosis factor-a and interleukin-1β concentrations, and increase interleukin-10 concentration after brain explosive injury in rabbits. These data suggest that vagus nerve stimulation may exert neuroprotective effects against explosive injury via regulating the expression of tumor necrosis factor-a, interleukin-1 β and interleukin-10 in the serum and brain tissue.

The mechanisms through which auricular vagus nerve stimulation protects against cerebral ischemia/reperfusion injury

Previous studies have shown that vagus nerve stimulation can improve patients' locomotor function.The stimulation of the auricular vagus nerve,which is the only superficial branch of the vagus nerve,may have similar effects to vagus nerve stimulation.However,the precise mechanisms remain poorly understood.In this study,rat models of cerebral ischemia/reperfusion injury were established by modified Longa ligation.Twenty-four hours later,7-day auricular vagus nerve stimulation was performed.The results showed that auricular vagus nerve stimulation promoted the secretion of acetylcholine,inhibited the secretion of interleukin-1β,interleukin-6,and tumor necrosis factor-α,and reduced connexin 43 phosphorylation in the ischemic penumbra and motor cortex,promoting locomotor function recovery in rats with cerebral ischemia/reperfusion injury.These findings suggested that auricular vagus nerve stimulation promotes the recovery of locomotor function in rats with cerebral ischemia/reperfusion injury by altering the secretion of acetylcholine and inflammatory factors and the phosphorylation of connexin 43.This study was approved by the Animal Use and Management Committee of Shanghai University of Traditional Chinese Medicine on November 8,2019(approval No.PZSHUTCM191108014).

A randomized trial comparing the Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members

Background:The present investigation tested the efficacy of the Tennant Biomodulator,a novel pain management intervention that uses biofeedback-modulated electrical stimulation,to reduce chronic pain and its psychosocial sequelae in a sample of current and former military service members.The Tennant Biomodulator used on its most basic setting was compared to two commonly used,non-pharmacological pain treatments—traditional Chinese acupuncture and transcutaneous electrical nerve stimulation(TENS)—in a comparative efficacy,randomized,open-label trial.Methods:Participants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas,USA,randomly assigned to receive six,weekly sessions of either Tennant Biomodulator treatment,traditional Chinese acupuncture,or TENS,in addition to usual care.Recruitment was conducted between May 2010 to September 2013.Outcome measures were collected at intake,before and after each treatment session,and at a 1-month follow-up.Intent-to-treat analyses were used throughout,with mixed models used to investigate main effects of group,time,and group×time interactions with consideration given to quadratic effects.Outcomes measured included ratings of chronic pain,pain-related functional disability,and symptoms of post-traumatic stress disorder(PTSD)and depression.Results:On average,regardless of their treatment group,participants exhibited a 16%reduction in pain measured by the Brooke Army Medical Center’s Clinic Pain Log[F(1,335)=55.7,P<0.0001]and an 11%reduction in pain-related disability measured by the Million Visual Analog Scale[MVAS:F(1,84)=28.3,P<0.0001]from baseline to the end of treatment,but no one treatment performed better than the other,and the reductions in pain and pain-related disability were largely lost by 1-month follow-up.Symptoms of PTSD and depression did not change significantly as a function of time or group.Conclusions:Findings build on previous work suggesting that traditional Chinese acupuncture and TENS can reduce pain and its functional sequelae without risks associated with pharmacological pain management.The Tennant Biomodulator used on its most basic setting performs as well as these other interventions.Based on the present findings,large,randomized controlled trials on the Tennant Biomodulator are indicated.Future work should test this device using its full range of settings for pain-related psychological health.Trial registration:Clincialtrials.gov(NCT01752010);registered December 14,2012.

Ultrasound Guidance and Nerve Stimulation Combined Versus Nerve Stimulation alone for Lumbar Plexus Block:A Randomized Controlled Trial

A nerve stimulation-guided lumbar plexus block is a well-established technique.It is not clear whether ultrasound guidance has additional value for this deep block technique.This study aimed to examine whether ultrasound guidance using a paramedian transverse scan through the intertransverse space(PMTS-ITS)approach in combination with nerve stimulation reduces the onset time of a complete sensory block.Forty-four patients who were scheduled to undergo arthroscopic knee surgery with an ultrasound visibility score(UVS)of≥10 for the lumbar plexus were enrolled and randomly allocated to the ultrasound guidance with nerve stimulation group(group U-N)or nerve stimulation group(group N)in this prospective,randomized,parallel-group,active-controlled study.The primary outcome was the onset time of a complete sensory block.The results showed that the onset time of a complete sensory block to pinprick and cold was 10(10–40)min and 10(10–40)min in group U-N,respectively,and 30(10–40)min and 20(10–40)min in group N(P=0.005,P=0.004),respectively.The performance time was 658±87 s in group U-N and 528±97 s in group N(P<0.001).There was no(0%)patient who required 5 or more needle passes in group U-N and 6(27.3%)in group N(P=0.028).The block failure rate was 9.1%in group U-N and 31.8%in group N(P>0.05).In conclusion,ultrasound guidance using the PMTS-ITS approach in combination with nerve stimulation led to a faster onset of a complete sensory block than nerve stimulation alone for a lumbar plexus block in patients with a UVS≥10.Ultrasound guidance with nerve stimulation significantly decreased the number of patients who required 5 or more needle passes.