Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial.

STUDY DESIGN: This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design. OBJECTIVE: To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin. SETTING: The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital. METHODS: Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests. RESULTS: Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline. CONCLUSION: Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry.Trial registration: Clinical Trials Registry India identifier: CTRI/2018/05/013735.

Conservative Management of Occipital Neuralgia Supported by Physical Therapy: A Review of Available Research and Mechanistic Rationale to Guide Treatment.

PURPOSE OF REVIEW: Conservative management is consistently recommended as a first line intervention for occipital neuralgia (ON); however, there is limited clinical research regarding conservative intervention for ON. This lack of research may lead to underutilization or unwarranted variability in conservative treatment. This article provides mechanism-based guidance for conservative management of ON as a component of a multimodal treatment approach, and discusses the role of the physical therapist in the care team. It also highlights opportunities for further research to refine conservative management of this condition. RECENT FINDINGS: Published research on conservative interventions specific to ON is limited to very low-quality evidence for the use of TENS. The contemporary shift toward precision pain management emphasizing treatment based on a patient's constellation of clinical features-a phenotype-rather than solely a diagnosis provides more personalized and specifically targeted pain treatment. This paradigm can guide treatment in cases where diagnosis-specific research is lacking and can be used to inform conservative treatment in this case. Various conservative interventions have demonstrated efficacy in treating many of the symptoms and accepted etiologies of ON. Conservative interventions provided by a physical therapist including exercise, manual therapy, posture and biomechanical training, TENS, patient education, and desensitization have mechanistic justification to treat symptoms and causes of ON. Physical therapists have adequate time and skill to provide such progressive and iterative interventions and should be included in a multimodal treatment plan for ON. Further research is required to determine appropriate dosing, sequencing, and progression of conservative treatments.

The effect of EMS, IFC, and TENS on patient-reported outcome measures for chronic low back pain: a systematic review and meta-analysis.

Introduction: Chronic low back pain (CLBP) is the leading cause of years lived with disability worldwide. Transcutaneous electrotherapies have been widely used to treat CLBP but, with the partial exception of transcutaneous electrical nerve stimulation (TENS), their effect on pain, disability, quality-of-life, and psychosocial outcomes have not been systematically reviewed. The purpose of this systematic review and meta-analysis was to clarify the overall effect of transcutaneous electrotherapies on patient-reported outcome measures (PROMs) in CLBP patients. Methods: Four databases and two study registries were searched for studies that utilized transcutaneous electrotherapies as a primary intervention for CLBP, compared against active or passive controls. Two reviewers independently extracted study data and assessed risk of bias. Studies were grouped by intervention vs. comparison, and by time of follow-up. Meta-analyses were conducted where appropriate. Results: A total of 89 full-text were assessed for eligibility; 14 studies were included, with 6 in the meta-analyses (all TENS or mixed TENS). Pain: meta-analyses revealed no significant difference for TENS vs. active control, TENS vs. passive control, or mixed TENS vs. active control at post-intervention, nor for mixed TENS vs. active control at 1-month post-intervention. Interferential current (IFC) was more effective than active control (2 studies), while electromyostimulation (EMS) was generally superior to passive, but not active, controls (6 studies). Disability: Meta-analyses revealed no significant difference for TENS vs. active control at post-intervention, mixed TENS vs. active control at post-intervention, or mixed TENS vs. active control at 1-month post-intervention. IFC was more effective than active control (2 studies), while the EMS results were mixed (6 studies). We were unable to perform meta-analyses for quality-of-life or psychosocial outcomes. Conclusion: There is moderate evidence that TENS is similar to all controls for improving pain and disability. There is limited evidence that IFC is superior to active controls for improving pain and disability. There is limited evidence that EMS is superior to passive but not active controls for improving pain, and similar to all controls for improving disability. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=452851, Identifier (CRD42023452851).

Open reduction and internal fixation of a radius and ulna fracture in a patient with an elbow arthrodesis: a case report.

This case report outlines the effective use of the Titanium Elastic Nail System (TENS) for treating a peri-implant mid-shaft radius and ulna fracture in a patient with previous elbow arthrodesis and rotational full-thickness flap coverage. Given the paucity of literature surrounding this complex problem, we present a minimally - invasive treatment option which facilitated complete fracture healing, demonstrating the TENS's efficacy in complex orthopedic scenarios.

Effect of Transcutaneous Electrical Nerve Stimulation on Gait Parameters in Dogs with Osteoarthritis.

Osteoarthritis is a common degenerative disease in dogs, often manifested as pain, joint swelling, and lameness. Despite the lack of scientific evidence for its treatment efficacy, transcutaneous electrical nerve stimulation (TENS) is used in dogs as a pain-relieving treatment. This randomised single-blinded cross-over study investigated the effect of TENS on gait parameters in fifteen dogs with osteoarthritis. Stance time, swing time, stride time, stride length, peak vertical force (%BW), vertical impulse (%BW*sec), and symmetry indices were obtained using a pressure-sensitive mat. TENS treatment of 80 Hz and 100 µs with an individually selected amplitude was conducted for 45 min once daily for a treatment period of seven or ten days. No significant differences were seen between TENS and placebo for any of the gait parameters. Hence, in this study, TENS did not affect gait parameters, compared to placebo. Further studies are needed to confirm the observations.

Comparative Analysis of High-Frequency and Low-Frequency Transcutaneous Electrical Stimulation of the Right Median Nerve in the Regression of Clinical and Neurophysiological Manifestations of Generalized Anxiety Disorder.

Background/Objectives: The anxiolytic effect of transcutaneous electrical nerve stimulation (TENS) is associated with the activation of endogenous inhibitory mechanisms in the central nervous system. Both low-frequency, high-amplitude TENS (LF-TENS) and high-frequency, low-amplitude TENS (HF-TENS) are capable of activating opioid, GABA, serotonin, muscarinic, and cannabinoid receptors. However, there has been no comparative analysis of the effectiveness of HF-TENS and LF-TENS in the treatment of GAD. The purpose of our research was to study the effectiveness of direct HF-TENS and LF-TENS of the right median nerve in the treatment of patients with GAD compared with sham TENS. Methods: The effectiveness of direct HF-TENS and LF-TENS of the right median nerve in the treatment of GAD was studied using Generalized Anxiety Disorder 7-item scale (GAD-7) and the Hamilton Anxiety Rating Scale (HAM-A). 40 patients underwent sham TENS, 40 patients passed HF-TENS (50 Hz-50 µs-sensory response) and 41 patients completed LF -TENS (1 Hz-200 µs-motor response) for 30 days daily. After completion of treatment, half of the patients received weekly maintenance therapy for 6 months. Electroencephalography was performed before and after treatment. Results: Our study showed that a significant reduction in the clinical symptoms of GAD as assessed by GAD-7 and HAM-A was observed after HF-TENS and LF-TENS by an average of 42.4%, and after sham stimulation only by 13.5% for at least 2 months after the end of treatment. However, LF-TENS turned out to be superior in effectiveness to HF-TENS by 51% and only on electroencephalography leads to an increase in PSD for the alpha rhythm in the occipital regions by 24% and a decrease in PSD for the beta I rhythm in the temporal and frontal regions by 28%. The prolonged effect of HF-TENS and LF-TENS was maintained without negative dynamics when TENS treatment was continued weekly throughout the entire six-month observation period. Conclusions: A prolonged anxiolytic effect of direct TENS of the right median nerve has been proven with greater regression of clinical and neurophysiological manifestations of GAD after LF-TENS compared to HF-TENS. Minimal side effects, low cost, safety, and simplicity of TENS procedures are appropriate as a home treatment modality.

An Outcome Analysis of Pediatric Diaphyseal Fractures Treated Surgically With the Titanium Elastic Nailing System.

Introduction Pediatric fractures account for one-fourth of all pediatric injuries. Stabilizing the fracture, regulating the length and alignment, encouraging bone healing, and minimizing morbidity and problems for the child and family are the objectives of treatment for diaphyseal fractures of long bones in children. Our goal is to investigate how pediatric diaphyseal long bone fractures are treated with a titanium elastic nailing system (TENS). Methods A prospective interventional study was conducted on 24 children who had displaced diaphyseal fractures of major long bones, involving 31 diaphyseal fractures of long bones. Utilizing Flynn's grading standards, the result was examined. Results The mean age was 12.20 years. The youngest child was seven years old and the eldest child was 16 years old. There were 20 boys (83.33%) and four girls (16.67%). The male-to-female ratio was noted to be 5:1. The commonest mode of injury was road traffic accidents (12 cases, 50%), followed by falls while playing (10 cases, 41.67%). Other causes included falls from height (one case, 4.17%) and blunt trauma (one case, 4.17%). The commonest bone to get fractured was the femur (37.50%), followed by both bones of the forearm (29.17%), tibia (20.83%), humerus (8.33%), and ulna alone (4.17%). The middle third (21 fractures, 67.74%) was the most prevalent location for fractures. Five fractures each (16.13%) accounted for in the proximal and distal thirds. Twelve fractures (38.71%) were detected on the left side, while the majority of fractures (19 fractures, 61.29%) were seen on the right side. Most of the fractures in this group were transverse fractures (18 fractures, 58.06%) followed by oblique fractures (eight fractures, 25.81%). Comminuted fractures accounted for five fractures (16.13%). Of the 31 fractures, open reduction had to be done in two fractures, after unsuccessful attempts at closed reduction. Closed reduction was done in 29 fractures. There were 15.12 weeks in the average union term. The range is six weeks to 39 weeks. The most frequent side effect was discovered to be skin irritation at the entry site. The extraosseous portion of nails caused irritation at two entry sites (6.45%). A case had delayed union (3.23%) and restricted knee range of movements. Conclusion For the treatment of juvenile diaphyseal fractures of the long bones, the TENS is the best option. It is a quick, straightforward, safe, dependable, and efficient way to treat pediatric long-bone fractures in patients aged five to 16 years. The healing process takes a fair amount of time, while the surgery takes less time. It does away with the necessity for extended bed rest and significantly shortens hospital stays. It provides stability and elastic mobility, which is perfect for early mobilization and quick union at the fracture site. It has a low rate of complications and produces excellent functional results.

The effect of bioelectric and manual impressions on quality of complete dentures and quality of life: A cross over pilot study.

Purpose: To compare the quality of complete dentures and quality of life of participants rehabilitated by using TENS (Transcutaneous electric nerve stimulation) facilitated impression making with manual impressions. Material and methods: Ten completely edentulous participants were enrolled in the crossover, pilot study. Participants were randomized in 2 groups. Five participants in each group were rehabilitated by dentures fabricated with TENS facilitated definitive impression technique (group T) and conventional impression technique (group C). In group T, Bioelectric border molding was done for the participants, that uses electric stimulation of the nerves supplying the muscles. In group C, incremental border molding using modeling plastic impression compound was carried out. Participants in each group used the dentures for 3 months. After 3 months, OHIP-EDENT questionnaire responses were obtained from the participants to observe the oral health related quality of life. A dental specialist recorded denture quality by Kapur scoring criteria. After one month wash period, the treatment was swapped between the groups. OHIP-EDENT scores and Kapur score were recorded for the alternate dentures after 3 months of use. Descriptive analysis was followed by Mann Whitney test to compare the overall scores between group T and group C for OHIP-EDENT, the scores for individual domains of OHIP-EDENT, and Kapur score for denture evaluation (α = 0.05). Results: The overall OHIP-EDENT scores within each domain were less in group T when compared with the scores in group C and Kapur score for group T was more than group C. The difference was statistically significant i.e. P = 0.002 & 0.003 respectively. Conclusions: Less OHIP-EDENT scores in group T imply better perception of quality of life of individuals due to better performance of stomatognathic system. The higher Kapur scores in group T signifies better quality of dentures when TENS was used for definitive impression making.

Efficacy of wet cupping in the pain management of cervical spondylosis - A randomized, controlled, open -label, parallel-group clinical trial.

BACKGROUND AND OBJECTIVE: Cervical spondylosis is a chronic degenerative process of the cervical spine characterized by pain in neck, degenerative changes in intervertebral disc and osteophyte formation. Cervical spondylosis is translated as Waja' ur Raqaba, a type of joint pain. The present study was aimed to evaluate the effect of wet cupping in the pain management of cervical spondylosis. METHODS: This Open, randomized, controlled, clinical study was conducted on 44 patients. Subjects in the test group (n = 22) received a series of three-staged wet cupping treatment, performed on 0, 7th and 14th day. Subjects in the control group (n = 22) received 12 sittings of Transcutaneous Electrical Nerve Stimulation (TENS): 6 sittings per week for two weeks. The objective findings of treatment were assessed with the help of VAS, Neck Disability Index (NDI) and Cervical range of motion. RESULTS: Intra group comparison in test group from baseline to 21st day were found highly significant (p < 0.001) in terms of VAS, NDI, Flexion, Extension and Left rotation score. While in Right rotation, Left rotation and Left lateral flexion score were found moderately significant (p < 0.01). Statistically significant difference was observed between two groups at 21st day in VAS scale, NDI, and Cervical range of motion score (p < 0.001). INTERPRETATION AND CONCLUSION: Hijama Bish Shart was found better in the management of pain due to cervical spondylosis than TENS. It can be concluded that Hijama Bish Shart may a better option for the pain management of cervical spondylosis. CLINICAL TRIAL REGISTRATION: The trial was registered on clinical trial registry website (www.ctri.nic.in) bearing a CTRI Number, CTRI/2020/03/024,249.

The Efficacy of the Addition of tDCS and TENS to an Education and Exercise Program in Subjects with Knee Osteoarthritis: A Randomized Controlled Trial.

Knee osteoarthritis (KOA) has a significant impact on patients' quality of life. This study aimed to assess the effectiveness of integrating transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) into an education and exercise program with the aim of decreasing pain and improving physical function in KOA. A randomized controlled trial with 65 KOA patients was conducted. The subjects were assigned to one of the following three groups: education and active exercise plus (1) double active tDCS and TENS, (2) active tDCS and sham TENS, and (3) double sham tDCS and TENS. Sessions were conducted over a 20 min period, whilst data on pain, chronic pain clinical variables, and physical function were collected. Although all groups showed improvement in pain-related symptoms in the short and medium term, the addition of tDCS and/or TENS did not significantly enhance the benefits of the exercise and education program. These findings suggest that an education and active exercise program in the treatment of KOA has a positive effect on pain, with or without the addition of tDCS and/or TENS.

Physical Modalities for the Treatment of Localized Provoked Vulvodynia: A Scoping Review of the Literature from 2010 to 2023.

Introduction: Localized provoked vulvodynia (LPV) is a prevalent sexual health condition with significant negative impacts on quality of life. There is a lack of consensus regarding effective management. Methods: We used Arksey and O'Malley's five-step method to identify, collate, and evaluate literature published between 2010 and 2023. The scoping review investigated the efficacy or effectiveness of interventions in the management of LPV. The aim of this paper is to map the literature on the efficacy or effectiveness of physical interventions. Results: The review produced 19 primary studies of physical interventions for LPV. These include acupuncture, laser therapy, physiotherapy, transcutaneous electrical nerve stimulation, low-intensity shockwave therapy, transcranial direct current stimulation, and vestibulectomy. Conclusion: Published studies that investigated a range of physical treatments for LPV showed some positive effects, except for transcranial direct-current stimulation. The remaining modalities demonstrated improved sexual pain and treatment satisfaction, when measured. Findings were mixed for non-sexual pain. There was insufficient evidence to draw conclusions regarding other outcomes. Researchers are encouraged to conduct larger, high-quality studies that sample more diverse patient populations and use patient-oriented outcomes to assess effectiveness of physical modalities.

Acute back pain: The role of medication, physical medicine and rehabilitation: WFNS spine committee recommendations.

Objectives: To formulate the most current, evidence-based recommendations for the role of medication, physical medicine, and rehabilitation in the management of acute low back pain lasting <4 weeks. Methods: A systematic literature search in PubMed and Google Scholar databases was performed from 2012 to 2022 using the search terms "acute low back pain," "drugs," "bed rest," "physical medicine," rehabilitation." Standardized screening criteria resulted in a total of 39 articles that were analyzed, including 16 RCTs, 8 prospective studies, 6 retrospective studies, and 9 systematic reviews. This up-to-date information was reviewed and presented at two separate meetings of the World Federation of Neurosurgical Societies (WFNS) Spine Committee. Two rounds of the Delphi method were utilized to vote on the statements and arrive at a positive or negative consensus. Results and conclusion: The WFNS Spine Committee finalized twelve recommendation guidelines on the role of medication, physical medicine and rehabilitation in the management of acute LBP. We advocate for a uniform approach to the treatment of these patients, including proper patient education and utilizing drugs with proven efficacy and minimal side effects. First-line pharmacologic agents are acetaminophen and NSAIDs; muscle relaxants can be used for spasms and pain reduction, and opioids should be minimized. Continued activity, rather than bed rest, is recommended, and lumbar spine orthotics may be used to reduce pain and augment functional status. Thermotherapy, cryotherapy, TENs, spinal manipulative therapy, and acupuncture may all be used as adjuncts to improve acute LBP.

Decreasing the blood flow of non-compressible intra-abdominal organs with non-invasive transcutaneous electrical stimulation.

Non-invasive neuromodulation of non-compressible internal organs has significant potential for internal organ bleeding and blood-shift in aero/space medicine. The present study aims to investigate the potential influences of the non-invasive transcutaneous electrical nerve stimulation (TENS) on multiple non-compressible internal organs' blood flow. Porcine animal model (n = 8) was randomized for a total of 48 neuromodulation sessions with two different TENS stimulation frequencies (80 Hz, 10 Hz) and a placebo stimulation. A combination of two different electrode configurations (Abdominal-only or Abdominal and hind limb) were also performed. Intraarterial blood flow measurements were taken during pre and post-stimulation periods at the left renal artery, common hepatic artery, and left coronary artery. Intracranial, and extracranial arterial blood flows were also assessed with digital subtraction angiography. TENS with abdominal-only electrode configurations at 10 Hz demonstrated significant reductions in average peak blood flow velocity (APV) of the common hepatic artery (p = 0.0233) and renal arteries (p = 0.0493). Arterial pressures (p = 0.0221) were also significantly lower when renal APV was reduced. The outcome of the present study emphasises the potential use of TENS in decreasing the blood flow of non-compressible internal organs when the correct combination of electrodes configuration and frequency is used.

Transcutaneous electric nerve stimulation of acupuncture points improves tolerance in adults undergoing diagnostic upper gastrointestinal endoscopy: a single-center, double-blinded, randomized controlled trial.

BACKGROUND: Oesophagogastroduodenoscopy (OGDS) is the most common diagnostic procedure for upper gastrointestinal diseases. It often causes discomfort and anxiety, which are only mitigated by systemic sedation. However, sedation poses additional risks of adverse cardiopulmonary events, increased medical costs, and prolonged recovery. Transcutaneous electrical nerve stimulation of acupuncture points (Acu-TENS) is a non-invasive and innovative approach that induces analgesic effect during endoscopy. This trial is the first to be reported in English that explores the potential of Acu-TENS to increase patient tolerance during non-sedated elective diagnostic OGDS. METHODS: A double-blinded randomized controlled trial involving 348 subjects was conducted at a tertiary hospital to evaluate the success rate of OGDS with Acu-TENS. Subjects aged 18-75 years scheduled for their first elective diagnostic OGDS were randomized into the intervention (Acu-TENS) and placebo arms. OGDS success was assessed based on subjects' satisfaction ratings on a Likert scale and procedure's technical adequacy. Secondary measures included subjects' willingness to undergo future OGDS under similar conditions, procedure duration, and the endoscopist's perceived ease of the procedure. RESULTS: OGDS success rates were significantly higher with Acu-TENS (77.8%) than with the placebo (68.0%; odds ratio [OR] 1.64, 95% confidence interval [CI] 1.01-2.66, p = 0.043). Subjects who received Acu-TENS expressed higher willingness for future OGDS (78.9%) than those who received the placebo (68.6%; OR 1.71, 95% CI 1.04-2.79, p = 0.031). Procedure duration were significantly shorter in the intervention arm (6.0 min) than in the placebo arm (10.0 min; p = 0.002). No adverse effects were reported, and endoscopists perceived similar procedure ease in both arms. CONCLUSIONS: Acu-TENS improved OGDS success and enhanced patients' experiences during non-sedated OGDS. It demonstrated safety with no side effects and reduced the procedure completion time. It could be used as an adjunct in non-sedated diagnostic OGDS.

A Sensory Feedback Neural Stimulator Prototype for Both Implantable and Wearable Applications.

The restoration of sensory feedback is one of the current challenges in the field of prosthetics. This work, following the analysis of the various types of sensory feedback, aims to present a prototype device that could be used both for implantable applications to perform PNS and for wearable applications, performing TENS, to restore sensory feedback. The two systems are composed of three electronic boards that are presented in detail, as well as the bench tests carried out. To the authors' best knowledge, this work presents the first device that can be used in a dual scenario for restoring sensory feedback. Both the implantable and wearable versions respected the expected values regarding the stimulation parameters. In its implantable version, the proposed system allows simultaneous and independent stimulation of 30 channels. Furthermore, the capacity of the wearable version to elicit somatic sensations was evaluated on healthy participants demonstrating performance comparable with commercial solutions.

Effects of Transcutaneous Electrical Nerve Stimulation with Taping on Wrist Spasticity, Strength, and Upper Extremity Function in Patients with Stroke: A Randomized Control Trial.

Objective: Six months after the onset of stroke, over 60% of patients experience upper limb dysfunction, with spasticity being a major contributor alongside muscle weakness. This study investigated the effect of transcutaneous electrical nerve stimulation (TENS) with taping on wrist spasticity, strength, and upper extremity function in patients with stroke. Methods: In total, 40 patients with stroke were included and randomly divided into two groups: the TENS + taping (n = 20, age 52.4 ± 9.3 (range: 39 to 70)) and TENS (n = 20, age 53.5 ± 10.8 (range: 39 to 74)) groups. All subjects performed 30 sessions of task-related training, which included 10 min of postural control training and 20 min of task performance. Additionally, all subjects received TENS on the spastic muscle belly for 30 min before task-related training. In the TENS + taping group, taping was additionally applied to the forearm and wrist but not in the TENS group. The Modified Ashworth Scale was used to measure spasticity, and a handheld dynamometer was used to measure muscle strength. The Fugl-Meyer Assessment of Upper Extremity was used to evaluate the functional ability of the upper extremity. Results: In the TENS + taping group, spasticity and upper extremity function were significantly improved as compared to those in the TENS group (p < 0.05). However, no significant difference in muscle strength was observed between the two groups (p > 0.05). Conclusions: This study demonstrated that the combination of TENS and taping for spasticity and function of the upper extremity was more effective in relieving the spasticity than TENS alone. Therefore, we suggest this combination as an additional treatment for spasticity and function of the upper extremity.

The efficacy of real versus sham external Trigeminal Nerve Stimulation (eTNS) in youth with Attention-Deficit/Hyperactivity Disorder (ADHD) over 4 weeks: a protocol for a multi-centre, double-blind, randomized, parallel-group, phase IIb study (ATTENS).

BACKGROUND: Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action. METHODS: A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment. DISCUSSION: This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD. TRIAL REGISTRATION: ISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325 .

Comparative Evaluation of Effect of TENS on Controlling Pain Associated with Orthodontic Separator Placement-A Clinical Study.

Aim: To assess and contrast the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy and topical anesthetic gel in reducing the level of pain associated with the placement of orthodontic separators. Materials and Methods: A cohort of 40 individuals, aged between 16 and 20 years, who were in need of fixed orthodontic treatment, was chosen for the study. Elastomeric separators were positioned bilaterally adjacent to the first molars in all participants, who were subsequently separated into two distinct cohorts. Those in group I received topical anesthetic gel, while those in group II underwent TENS therapy. After the placement of separators, the assessment of pain was conducted using the Visual Analog Scale (VAS) at specific intervals: Immediately after placement, 6, 12, 24, and 48 hours. Result: TENS group showed a significantly lower VAS score compared to the local anesthetic gel group at immediate, 6 hours, and 12 hours. Conclusion: Following the placement of elastomeric separators, it was found that TENS was more successful at reducing pain.

The Effects Of Transcutaneous Electrical Nerve Stimulation Applied in the Early Postpartum Period After Cesarean Birth on Healing, Pain, and Comfort.

INTRODUCTION: This study was conducted to determine the effects of transcutaneous electrical nerve stimulation (TENS) applied in the early postpartum period after cesarean birth on incision site healing, postoperative recovery, pain, and comfort. METHODS: This randomized, single-blind, placebo-controlled study was conducted with 138 women (TENS group n = 46, placebo group n = 46, control group n = 46) who gave birth by cesarean between January and September 2023. TENS was applied twice at a frequency of 100 Hz with a pulse width of 100 microseconds, at 10 to 12 and 14 to 16 hours after birth, for 30 minutes each. Outcomes were measured with the Postoperative Recovery Index; Redness, Edema, Ecchymosis, Discharge, and Approximation Scale; Visual Analogue Scale; and Postpartum Comfort Questionnaire. Outcomes between groups were compared postintervention, correcting for baseline using analysis of covariance. The study was registered at www. CLINICALTRIALS: gov (NCT05991921). RESULTS: Mean scores for postoperative recovery were significantly lower (improved) in the TENS group (113.58) compared with the placebo and control groups (134.67, 136.61; P < .001). The postoperative recovery subscales (psychological symptoms, physical activities, appetite symptoms, bowel symptoms, general symptoms) were also significantly decreased in the TENS group compared with the placebo and control groups. Similarly, mean scores for postpartum comfort, and the corresponding physical comfort, psychospiritual comfort, and sociocultural comfort subscales, were significantly improved in the TENS group (110.26) compared with the placebo and control group (83.80, 81.19; P < .05). DISCUSSION: TENS application can be preferred as an alternative method to increase pain control, recovery, and patient comfort after cesarean birth.