Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial.

BACKGROUND: Low back pain (LBP) is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Transcutaneous electrical nerve stimulation (TENS) may benefit people with chronic LBP because it can activate descending inhibitory pathways and inhibit central excitability. However, previous studies that have investigated the effects of TENS on pain in people with LBP have failed to use proper intensities of current, and the timing of the assessment of pain was not performed during the peak of the analgesic response or functional activities. Therefore, the present study aims to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS in participants with LBP. METHODS/DESIGN: This study will be a randomized crossover trial. The participants for this study will be recruited from various places, including the University of Hartford, physical therapy clinics, and local businesses in the Hartford area, as well as online websites geared towards clinical trial recruitment. A total of 34 participants will receive all three treatments: active TENS, placebo TENS, and no treatment control. The treatment order will be randomized using a website-based randomization tool. For active TENS, a modulating frequency of 2-125 Hz will be applied with a variable pulse duration and maximal tolerable intensity for 30 min. The TENS will be left on for post-treatment testing to assess the effects during its maximally effective period for a total of 50 to 60 min. Furthermore, the intensity may be turned down if muscle twitching is present to ensure blinding of the evaluator. For placebo TENS, the unit will deliver current for 45 s, ramping to 0 in the last 15 s. The primary outcome will be pain intensity at rest and with movement, determined using the numerical pain rating scale. The secondary outcomes will be pressure pain threshold, heat pain threshold, temporal summation of pain, conditioned pain modulation, sit-to-stand test, and repeated trunk flexion. The assessments will be performed immediately before and after treatment. Statistical analysis of the data obtained will consider a significance level of p < 0.05. DISCUSSION: This study will provide evidence concerning the effects and mechanisms of TENS treatment in participants with chronic non-specific low back pain. The outcomes, including pain, function, and descending inhibition, will help us gain a greater understanding of how TENS can be used for these participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT05812885. Registered on 24th May 2023.

Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis.

BACKGROUND: Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022. RESULTS: Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. CONCLUSIONS: Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.

Percutaneous electrical nerve stimulation in post-mastectomy neuropathic pain: A case report.

Post-mastectomy pain syndrome (PMPS) is a type of chronic postsurgical pain that can be severe, debilitating and frequently encountered in clinical practice. Multiple studies have focused on prevention, identifying risk factors and treating this condition. Nonetheless, PMPS remains a complex condition to treat effectively. In this case report, we describe the use of percutaneous electrical nerve stimulation in a breast cancer patient who experienced PMPS refractory to conventional treatments.

Noninvasive electrical neuromodulation for gastrointestinal motility disorders.

INTRODUCTION: Gastrointestinal motility disorders are highly prevalent without satisfactory treatment. noninvasive electrical neuromodulation is an emerging therapy for treating various gastrointestinal motility disorders. AREAS COVERED: In this review, several emerging noninvasive neuromodulation methods are introduced, including transcutaneous auricular vagal nerve stimulation, percutaneous auricular vagal nerve stimulation, transcutaneous cervical vagal nerve stimulation, transcutaneous electrical acustimulation, transabdominal interference stimulation, tibial nerve stimulation, and translumbosacral neuromodulation therapy. Their clinical applications in the most common gastrointestinal motility are discussed, including gastroesophageal reflux disease, functional dyspepsia, gastroparesis, functional constipation, irritable bowel syndrome, and fecal incontinence. PubMed database was searched from 1995 to June 2023 for relevant articles in English. EXPERT OPINION: Noninvasive neuromodulation is effective and safe in improving both gastrointestinal symptoms and dysmotility; it can be used when pharmacotherapy is ineffective. Future directions include refining the methodology, improving device development and understanding mechanisms of action.

Efficacy of sacral transcutaneous electrical nerve stimulation in patients with overactive bladder refractory to anticholinergic treatment: a prospective multi-center study. / Eficacia de la electroestimulación transcutánea sacra en pacientes con vejiga hiperactiva refractarios a fármacos anticolinérgicos. Estudio prospectivo y multicéntrico.

OBJECTIVE: To determine whether sacral transcutaneous electrical nerve stimulation (S-TENS) is an effective treatment in patients refractory to anticholinergic drugs (Achs). MATERIALS AND METHODS: A prospective multi-center study of patients with overactive bladder (OB) refractory to Achs treated with S-TENS from 2018 to 2021 was carried out. S-TENS was applied over 3 months. Symptom progression was assessed using the voiding calendar and the Pediatric Lower Urinary Tract Symptoms Score (PLUTSS), excluding questions 3 and 4 -referring to enuresis- so that progression of daytime symptoms only (LUTS variable) was analyzed. RESULTS: 66 patients -50% of whom were female- were included, with a mean age of 9.5 years (range: 5-15). S-TENS significantly lowered PLUTSS (19.1 baseline vs. 9.5 final, p< 0.001) and LUTS (13.1 baseline vs. 4.8 final, p< 0.001). It also reduced the number of mictions (8.5 baseline vs. 6.4 final, p< 0.001), while increasing urine volume in the voiding records (214 ml baseline vs. 258 ml final, p< 0.001). Enuresis was the only variable refractory to S-TENS. Complication rate was 3% (2 patients with dermatitis in the S-TENS application area). CONCLUSIONS: S-TENS is effective and safe in the short-term in patients with OB refractory to Achs. Further studies assessing long-term efficacy and potential relapses are required.

OBJETIVOS: Determinar si la electroterapia nerviosa transcutánea a nivel sacro (TENS-S) es un tratamiento efectivo en pacientes refractarios a fármacos anticolinérgicos (Ach). MATERIAL Y METODOS: Estudio prospectivo y multicéntrico: pacientes con VH refractaria a Ach tratados con TENS-S entre 2018-2021. El TENS-S se aplicó durante 3 meses. La evolución sintomática fue evaluada utilizando el calendario miccional y el cuestionario PLUTSS (Pediatric Lower Urinary Tract Symptoms Score), pero excluyendo sus preguntas 3 y 4 (referidas a la enuresis) para analizar solamente la evolución de la sintomatología diurna (variable LUTS). RESULTADOS: Fueron incluidos 66 pacientes (50% niñas), con una edad media de 9,5 años (rango: 5-15). El TENS-S disminuyó significativamente el PLUTSS (19,1 inicial vs 9,5 final, p< 0,001) y el LUTS (13,1 inicial vs 4,8 final, p< 0,001). Además, redujo el número de micciones (8,5 inicial vs 6,4 final, p< 0,001) y aumentó el volumen de orina en los registros miccionales (214 ml inicial vs 258 ml final, p< 0,001). La enuresis fue la única variable refractaria al TENS-S. La tasa de complicaciones fue del 3% (2 pacientes, dermatitis en el área de aplicación del TENS-S). CONCLUSIONES: El TENS-S es efectivo y seguro a corto plazo en pacientes con VH refractarios a los Ach. Deben realizarse estudios para evaluar la eficacia a largo plazo y posibles recaídas.

Comparing the effect of transcutaneous electrical nerve stimulation and massage therapy on post laparoscopic shoulder pain: a randomized clinical trial.

BACKGROUND: Shoulder pain is a common clinical problem after laparoscopic surgeries. The use of non-pharmacological massage and transcutaneous electrical nerve stimulation (TENS) as an adjunct to routine treatment is increasing to provide optimal pain relief. Therefore, we aimed to determine the effect of TENS and massage therapy on post laparoscopic shoulder pain (PLSP). METHODS: This study was conducted on 138 patients who underwent laparoscopic cholecystectomy. Patients were randomly divided into three groups: massage plus conventional pharmacological treatment (n = 46), TENS plus conventional pharmacological treatment (n = 46), and conventional pharmacological treatment (n = 46). Massage and TENS were performed three consecutive times after the patients regained consciousness in the inpatient wards. The intensity of Shoulder pain was evaluated using a visual analog scale before and 20 min after each treatment. RESULTS: Both massage therapy and TENS led to a significant reduction in the intensity of PLPS compared to the control group in all three measured times (p < 0.001). However, no significant difference was observed between TENS and massage at any of the three-time points. CONCLUSIONS: This study's findings demonstrated that massage and TENS techniques could reduce PLSP. TRIAL REGISTRATION: Registered in the Iranian registry of clinical trials ( www.irct.ir ) in 05/02/2022 with the following code: IRCT20200206046395N1.

Efficacy and safety of the TENSI+ device for posterior tibial nerve stimulation: A multicenter, retrospective study.

OBJECTIVES: Transcutaneous posterior tibial nerve stimulation (TC-PTNS) is a validated option for lower urinary tract symptoms (LUTS) management, with a short-term success rate of around 60% and few adverse events. Our goal was to report the efficacy and safety results of TC-PTNS using the newly issued device TENSI+ for LUTS management. PATIENTS AND METHODS: A multicenter, retrospective study was conducted in 7 urology departments in France. All patients treated with TC-PTNS for LUTS using the TENSI+ device between September 2021 and February 2022 were included. All patients received supervised at-home training by a specialized nurse. All patients were asked to do daily, 20minutes sessions of TC-PTNS. Patient demographics, history, initial symptoms and previous treatment were collected at inclusion. A follow-up visit was scheduled at 3 months. Efficacy was evaluated through treatment persistence at 3 months and PGI-I (Patient Global Impression of Improvement) score. Adverse events were recorded. RESULTS: One hundred and three patients (86 women and 17 men) were included. All patients had overactive bladder symptoms, 64 suffered from urgency incontinence, and 24 had associated voiding symptoms. Eighteen patients had neurogenic background, and 30 previously received anticholinergics. After a median follow-up of 12 [10-21]weeks, 70 patients were still using the device (68%). PGI-I score reflected an improvement in 70.9% and was 1, 2 and 3 in 28, 26 and 19 patients respectively, while 24 were unchanged and 6 were worse. No clinical baseline parameter was predictive of success. Adverse events included pain at stimulation site (two cases) and pelvic pain (two patients), which rapidly resolved after treatment interruption. CONCLUSIONS: TC-PTNS with TENSI+ device is an effective option for LUTS management, with results that seem similar to other TC-PTNS approaches. Adverse events were mild and reversible after treatment interruption.

Clinical management of salivary gland hypofunction in patients with head and neck cancer: a scoping review of physical salivary stimulation methods.

OBJECTIVE(S): This scoping review aims to map the scientific literature on the therapies currently available for physical salivary stimulation in individuals with hyposalivation caused by radiotherapy. STUDY DESIGN: Studies were included when they comprised the target population of adult individuals receiving radiotherapy of the head and neck region and who developed or were at risk of developing hyposalivation. Two reviewers selected the studies and extracted data on the type of physical salivary stimulation therapy used, the degree of glandular tissue involvement, and the percentage of salivary flow alteration. Therapies were classified according to either prophylactic application (before/during radiotherapy) or therapeutic application (post-radiotherapy). RESULTS: Sixteen articles were included: 4 tested transcutaneous electrical nerve stimulation (TENS), 3 studied low-level lasers, 7 researched acupunctures, and 2 investigated acupuncture-like TENS. The outcomes of the prophylactic studies indicated beneficial effects (similar salivary flow or reduced salivary flow loss), although most studies did not include a comparable control group. Therapeutic studies presented conflicting results. CONCLUSION(S): Prophylactic therapies of physical salivary stimulation may produce better effects than therapeutic applications. However, the protocols best indicated could not be defined. Well-designed, controlled clinical trials should be researched in the future to support the clinical recommendation of any of these treatments.

Acute transcutaneous electrical stimulation (TES) augments esophageal contractility in patients with weak peristalsis.

BACKGROUND: Lung transplantation (LTx) remains controversial in patients with absent peristalsis (AP) given the increased risk for gastroesophageal reflux (GER), and chronic lung allograft dysfunction. Furthermore, specific treatments to facilitate LTx in those with AP have not been widely described. Transcutaneous Electrical Stimulation (TES) has been reported to improve foregut contractility in LTx patients and therefore we hypothesize that TES may augment the esophageal motility of patients with ineffective esophageal motility (IEM). METHODS: We included 49 patients, 14 with IEM, 5 with AP, and 30 with normal motility. All subjects underwent standard high-resolution manometry and intraluminal impedance (HRIM) with additional swallows as TES was delivered. RESULTS: TES induced a universal impedance change observable in real-time by a characteristic spike activity. TES significantly augmented the contractile vigor of the esophagus measured by the distal contractile integral (DCI) in patients with IEM [median DCI (IQR) 0 (238) mmHg-cm-s off TES vs. 333 (858) mmHg-cm-s on TES; p = .01] and normal peristalsis [median DCI (IQR) 1545 (1840) mmHg-cm-s off TES vs. 2109 (2082) mmHg-cm-s on TES; p = .01]. Interestingly, TES induced measurable contractile activity (DCI > 100 mmHg-cm-s) in three out of five patients with AP [median DCI (IQR) 0 (0) mmHg-cm-s off TES vs. 0 (182) mmHg-cm-s on TES; p < .001]. CONCLUSION: TES acutely augmented contractile vigor in patients with normal and weak/ AP. The use of TES may positively impact LTx candidacy, and outcomes for patients with IEM/AP. Nevertheless, further studies are needed to determine the long-term effects of TES in this patient population.

Managing acute phantom limb pain with transcutaneous electrical nerve stimulation: a case report.

INTRODUCTION: Phantom limb pain is characterized by painful sensations in the amputated limb. The clinical presentation of acute phantom limb pain may differ from that of patients with chronic phantom limb pain. The variation observed implies that acute phantom limb pain may be driven by peripheral mechanisms, indicating that therapies focused on the peripheral nervous system might be successful in reducing pain. CASE PRESENTATION: A 36-year-old African male with acute phantom limb pain in the left lower limb, was treated with transcutaneous electrical nerve stimulation. CONCLUSION: The assessment results of the presented case and the evidence on acute phantom limb pain mechanisms contribute to the current body of literature, indicating that acute phantom limb pain presents differently to chronic phantom limb pain. These findings emphasize the importance of testing treatments that target the peripheral mechanisms responsible for phantom limb pain in relevant individuals with acquired amputations.

Efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting: A systematic review and meta-analysis.

BACKGROUND: Postoperative nausea and vomiting are typical postsurgical complications. Drug therapy is only partially effective. The goal of our meta-analysis is to systematically evaluate the efficacy and safety of electrical acupoint stimulation for postoperative nausea and vomiting and to score the quality of evidence supporting this concept. METHODS: PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched from inception to March 19, 2020. RESULTS: Twenty-six studies (2064 patients) were included. Compared with control treatment, electrical acupoint stimulation reduced the incidence of postoperative nausea and vomiting (RR 0.49, 95% CI 0.41 to 0.57, P < 0.001), postoperative nausea (RR 0.55, 95% CI 0.47 to 0.64, P < 0.001) and postoperative vomiting (RR 0.56, 95% CI 0.45 to 0.70, P < 0.001). Electrical acupoint stimulation also reduced the number of patients requiring antiemetic rescue (RR 0.60, 95% CI 0.43 to 0.85, P = 0.004). No differences in adverse events were observed. Subgroup analysis showed that both electroacupuncture (RR 0.58, 95% CI 0.46 to 0.74, P < 0.001) and transcutaneous electrical acupoint stimulation (RR 0.44, 95% CI 0.34 to 0.58, P < 0.001) had significant effects. Electrical acupoint stimulation was effective whether administered preoperatively (RR 0.40, 95% CI 0.27 to 0.60, P < 0.001), postoperatively (RR 0.59, 95% CI 0.46 to 0.76, P < 0.001), or perioperatively (RR 0.50, 95% CI 0.37 to 0.67, P < 0.001). The quality of evidence was moderate to low. CONCLUSIONS: Electrical acupoint stimulation probably reduce the incidence of postoperative nausea and vomiting, postoperative nausea, postoperative vomiting, and reduce the number of patients requiring antiemetic rescue, with few adverse events.

Transcutaneous tibial nerve electrical stimulation versus vaginal electrical stimulation in women with overactive bladder syndrome: Is there a role for short-term interventions?

OBJECTIVE: To assess the efficacy of vaginal electrical stimulation (VS) versus transcutaneous tibial nerve electrical stimulation (TTNS) in women with overactive bladder syndrome (OAB). MATERIAL AND METHODS: Sixty-nine patients were randomized to receive 12 sessions of VS versus TTNS, or no treatment (control group-CG), over 6 weeks. OAB impact according to international consultation on incontinence questionnaire overactive bladder module (ICIQ-OAB), symptoms discomfort scores and voiding diaries were evaluated at baseline, 6 weeks and 1-month post-treatment. RESULTS: Both TTNS (mean difference = -4.2; 95% confidence interval [CI] = -6.5 to -1.9) and VS (-3.8; -6.0 to -1.6) were associated with significant reduction of ICIQ-OAB scores, as well as discomfort sensation (-3.9; -6.2 to -1,7; p < 0.001 for the TTNS and -2.8; -5.0 to -0.6; p = 0.01 for the VS) at 6 weeks when compared to CG (p < 0.001). ICIQ-OAB score remained low only in the TTNS group when compared to the CG (-3.6; -6.0 to -1.2/p = 0.00) 1 month after treatment. Discomfort symptoms improved in both active groups when compared to CG (TTNS [-3.2; -5.2 to -1.2; p < 0.001] and VS groups [-2.6; -4.7 to -0.6; p = 0.01]). No statistically differences were found in primary outcomes comparing TTNS and VS Secondary analysis showed significant improvement in urinary urgency incontinence episodes (UUI) in both TTNS and VS, but CG. UUI episodes were still reduced in the VS group and urgency in the TTNS group 1-month post-treatment. CONCLUSION: Short-term interventions (6 weeks) of TTNS and VS were both effective in treating women with OAB. TTNS provided residual effects at one-month postintervention on ICIQ-OAB score.

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder.

OBJECTIVES: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.). METHODS: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated. RESULTS: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week. CONCLUSIONS: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.

Transcutaneous electrical acupoint stimulation to reduce opioid consumption in patients undergoing inguinal hernia repair: protocol for a randomized controlled trial.

BACKGROUND: The purpose of this study is to evaluate the efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) in the postoperative treatment of patients undergoing inguinal hernia repair compared with sham and no treatment group. METHODS: This study is a protocol for a three-armed, single-blinded, placebo-controlled randomized controlled trial. Ninety participants scheduled for inguinal hernia repair will be randomly assigned to the TEAS group (n = 30), sham group (n = 30), and control group (n = 30). The TEAS group will receive treatment using four portable coin-sized electro-stimulators at both local and distal acupuncture points. The sham group will receive sham treatment with mock electrostimulation. The treatment groups will receive mixed frequency stimulation (alternating at 2 and 100 Hz every 3 s) in continuous mode for 30 min at intervals of 2 h for 24 h postoperatively. The control group will receive postoperative pain control using patient-controlled analgesia (PCA) device. The primary outcome is the total morphine dose received in the postoperative period (mg) using PCA 24 h after surgery. The number of PCA demands (i.e., times the button will be pressed) and delivered bolus doses, score on the Visual Analogue Scale, opioid-related side effects, the requirement for supplemental medications, score on the Hospital Anxiety and Depression Scale (HADS), and blood levels of stress hormones cortisol and prolactin. DISCUSSION: The results of this trial will determine whether TEAS with intensified stimulation protocol is a safe and effective option for reducing analgesic consumption and postoperative pain. TRIAL REGISTRATION: ISRCTN76428396. Registered on 05 October 2020. https://www.isrctn.com/ISRCTN76428396.

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.

Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.

Using TENS for Pain Control: Update on the State of the Evidence.

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the treatment of acute and chronic pain conditions. The first clinical studies on TENS were published over 50 years ago, when effective parameters of stimulation were unclear and clinical trial design was in its infancy. Over the last two decades, a better understanding of the mechanisms underlying TENS efficacy has led to the development of an adequate dose and has improved outcome measure utilization. The continued uncertainty about the clinical efficacy of TENS to alleviate pain, despite years of research, is related to the quality of the clinical trials included in systematic reviews. This summary of the evidence includes only trials with pain as the primary outcome. The outcomes will be rated as positive (+), negative (-), undecided (U), or equivalent to other effective interventions (=). In comparison with our 2014 review, there appears to be improvement in adverse events and parameter reporting. Importantly, stimulation intensity has been documented as critical to therapeutic success. Examinations of the outcomes beyond resting pain, analgesic tolerance, and identification of TENS responders remain less studied areas of research. This literature review supports the conclusion that TENS may have efficacy for a variety of acute and chronic pain conditions, although the magnitude of the effect remains uncertain due to the low quality of existing literature. In order to provide information to individuals with pain and to clinicians treating those with pain, we suggest that resources for research should target larger, high-quality clinical trials including an adequate TENS dose and adequate timing of the outcome and should monitor risks of bias. Systematic reviews and meta-analyses should focus only on areas with sufficiently strong clinical trials that will result in adequate sample size.

TENS Improves Cisplatin-Induced Neuropathy in Lung Cancer Patients.

Background: Cisplatin-induced peripheral neuropathy is a common complication of cisplatin therapy, which develops in most patients with lung cancer. There are no effective preventive measures and once it occurs there is no effective therapy, except symptomatic. In this study, we aimed to assess the effect of transcutaneous electrical nerve stimulation (TENS) therapy on the pain intensity and the quality of life of patients with cisplatin-induced neuropathy. Material and Methods: A prospective cohort study was performed from 2013 to 2018, at the Clinical Center of Serbia. After the initial evaluation of 106 newly diagnosed patients with lung cancer, 68 patients did not have peripheral neuropathy. These 68 patients continued in the study and started the cisplatin chemotherapy. Forty of these patients developed cisplatin-induced neuropathy, which was manifested by neuropathic symptoms and proven by ENG examination. All patients with cisplatin-induced neuropathy were treated with TENS therapy. Their neuropathic pain and quality of life were evaluated using the following questionnaires at diagnosis, after cisplatin therapy and after four weeks of TENS use: DN4, VAS scale, EORTC QLQ-C30 and FACT-L. Results: Two thirds (68%) of the patients with cisplatin-induced neuropathy were male and the majority were smokers (70%). Adenocarcinoma was the most common (38%), followed by squamous (33%) and small-cell carcinoma (28%). The application of TENS therapy had a positive effect on reducing the neuropathic pain and increasing the quality of life for patients with painful cisplatin-induced neuropathy. The VAS and DN4 scores significantly decreased after TENS therapy, in comparison to its values after cisplatin therapy (p < 0.001). After TENS therapy, patients had significantly higher values in most of the domains of EORTC QLQ-C30 and FACT- L, in comparison with the values after cisplatin therapy (p < 0.001). Conclusion: The application of TENS therapy has a positive effect on reducing neuropathic pain and increasing the quality of life for patients with lung cancer and cisplatin-induced neuropathy.

Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson's Electronically (STRIPE trial): a randomised control trial of tibial nerve stimulation for bladder symptoms in Parkinson's disease using a self-contained wearable device.

BACKGROUND: Bladder symptoms are common in Parkinson's disease (PD), affecting half of all individuals. These have significant impact on quality of life as well as implications for morbidity, contributing to falls and hospital admission. The treatment of bladder symptoms can be complicated by the tendency to side-effects in people with PD including cognitive impairment and gait instability with anti-muscarinics. The development of new, better treatments is therefore warranted. Tibial nerve stimulation is a form of neuromodulation demonstrated to improve overactive bladder symptoms in non-neurogenic cohorts. Previously requiring hospital attendance, we aim to explore the use of this intervention using a simple device that can be used by patients at home. METHODS: STRIPE is a phase II randomised control trial of tibial nerve stimulation delivered by the Geko™ device, a small, self-adhesive neuromuscular stimulation device currently used for thromboembolism prophylaxis post-surgery. Active tibial nerve stimulation will be compared to sham stimulation, with participants blinded to treatment allocation and undertaking outcome assessment whilst still blinded. Participants will be asked to self-administer stimulation at home twice per week, for 30 min per session, over the course of 3 months. Primary outcome measure will be the International Consultation on Incontinence Overactive Bladder Questionnaire (OAB) at week 12. Secondary outcomes will include pre- and post-intervention bladder diary (frequency, urgency episodes, nocturia), patient perception of global change, bowel function and bladder-related quality of life. Participants will be recruited from the Proactive Integrated Management and Empowerment (PRIME) cross-sectional trial in which participants have been screened for bladder symptoms and invited to take part, as well as clinician referral from around the region. DISCUSSION: This trial will involve a randomised control trial of a novel and easy to use method of delivering tibial nerve stimulation for PD in the patient's own home. This may potentially have huge benefit, avoiding the problems with side effects that can be seen with anti-muscarinics and providing a new potential modality of treatment. TRIAL REGISTRATION: ISRCTN11484954. Registered on 22 June 2021.

TENS and EMS Treatment for Diabetic Peripheral Neuropathy.

Context: Diabetic peripheral neuropathy (DPN) is a common complication occurring in both type 1 and type 2 diabetics. DPN may result in foot ulceration or lower-limb amputation. Objective: This case was undertaken to evaluate the efficacy of ReBuilder® therapy in the treatment of diabetic peripheral neuropathy. Methods: The case report is based on 3 selected patients, 2 males and 1 female. Each patient continued being managed by his/her primary care physician. No changes to allopathic medicine or diet were advised by our team. In addition to the allopathic therapy, we added ReBuilder® therapy, low level light therapy, vibration therapy and supplementation. The treatment period ranged from 17 to 20 weeks. Conclusion: The data presented here show promise for future, larger, controlled studies on the use of ReBuilder® devices for the treatment of diabetic peripheral neuropathy pain.

Extending Perioperative Analgesia with Ultrasound-Guided, Percutaneous Cryoneurolysis, and Peripheral Nerve Stimulation (Neuromodulation).

The use of regional anesthesia is key to a successful approach to improving postoperative analgesia, which involves local anesthetic deposition either around peripheral nerves or within a fascial plane. Unfortunately, the realistic duration even with continuous peripheral nerve blocks usually does not match the duration of surgical pain, comprising a major limitation. Here, the use of 2 interventional modalities-ultrasound-guided percutaneous cryoneurolysis and peripheral nerve stimulation-is discussed, both of which may be used to treat acute and subacute pain and may therefore have a positive impact on the incidence and severity of chronic pain development.