Transcutaneous Electrical Nerve Stimulation Device Research Articles

Transcutaneous electrical nerve stimulation for fibromyalgia-like syndrome in patients with Long-COVID: a pilot randomized clinical trial

This study investigated the effect of Transcutaneous Electrical Nerve Stimulation (TENS) for fibromyalgia-like symptoms including chronic widespread musculoskeletal pain, fatigue, and/or gait impairment in twenty-five individuals with long-COVID. Participants were randomized to a high dose (intervention group, IG) or low dose (placebo group, PG) TENS device. Both groups received daily 3–5 h of TENS therapy for 4-weeks. The Brief Pain Inventory assessed functional interference from pain (BPI-I), and pain severity (BPI-S). The global fatigue index (GFI) assessed functional interference from fatigue. Wearable technology measured gait parameters during three 30-feet consecutive walking tasks. At 4-weeks, the IG exhibited a greater decrease in BPI-I compared to the PG (mean difference = 2.61, p = 0.008), and improved in gait parameters including stride time (4-8%, test condition dependent), cadence (4-10%, depending on condition), and double-support phase (12% in dual-task) when compared to baseline. A sub-group meeting the 2010 American College of Rheumatology Fibromyalgia diagnostic criteria undergoing high-dose TENS showed GFI improvement at 4-weeks from baseline (mean change = 6.08, p = 0.005). Daily TENS therapy showed potential in reducing functional interference from pain, fatigue, and gait alterations in long-COVID individuals. The study’s limited power could affect the confirmation of certain observations. Extending the intervention period may improve treatment effectiveness.

Home Transcutaneous Electrical Stimulation Rehabilitation Program for Patients With Ankylosing Spondylitis: Crossover Trial.

Maintaining physical function and preserving spinal flexibility have been challenging in managing ankylosing spondylitis (AS). Most rehabilitation programs, including manual therapy, massage, hydrotherapy, and acupuncture, cannot be performed at home. The effect of transcutaneous electrical nerve stimulation (TENS) was validated in treating AS, but no home TENS system has explored its efficacy to date. This study aims to evaluate the efficacy of a home TENS system with a novel treatment program for patients with AS. The modified WeHeal TS-200 TENS and galvanic response system provided home-based TENS treatment for patients with AS. Patients were divided into a 2-month course group and a 1-month course group. After the first treatment course, patients went through a washout period for the same duration of their treatment course. Participants could decide whether to accept the second course of treatment. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Schober test, finger-to-floor flexion test, enthesis score, cytokines, chemokines, inflammatory factors, and immunoglobulins were measured to evaluate its efficacy. The clinical trial protocol (1096607481) received approval from the Ministry of Health and Welfare in Taiwan. A total of 9 patients (5 in a 2-month course group and 4 in a 1-month course group) completed the first treatment course, and 5 patients (4 in a 2-month course group and 1 in a 1-month course group) completed the sequential treatment course. The weighted results showed that patients reported an improving BASFI score (mean difference -0.9, SD 1.7; P=.03) after treatment. Looking into the trajectories, declined BASFI and BASDAI scores were noticed during treatments; this score increased during the washout period. There were improving trends in the Schober test (mean difference 1.9, SD 4.9; P=.11) and finger-to-floor flexion test (mean difference -0.6, SD 9.5; P=.79), but the results were not statistically significant. The response of cytokines, chemokines, inflammatory factors, and immunoglobulins before and after treatment did not show a consistent trend, and all results were not statistically significant (all P>.05). The home TENS device demonstrated a potential role in AS management. It may improve accessibility and adherence for patients with AS and provide remote monitoring for clinicians. Further research can compare the effectiveness of electrotherapy at home or in a medical setting and focus on integrating the home TENS system and exercise program to enhance patients' physical functions and spinal flexibility.

Usefulness and Safety of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Promoting Exercise Therapy in Patients With Chronic Knee Pain: A Randomized Controlled Trial

ObjectiveTo investigate the effect of transcutaneous electrical nerve stimulation (TENS) in reducing barriers to the implementation of exercise therapy and promoting exercise therapy, focusing on physical activity (PA). DesignA single-center, participant-blinded, randomized controlled trial with a pre-post design. SettingOrthopedic clinic at a single institution,. ParticipantsParticipants (N=63, aged ≥50y) who had knee pain for ≥3 months were randomly assigned to the TENS (N=21), exercise (N=23), or combined (N=19) groups. InterventionsParticipants were provided with 4 weeks of intervention: the TENS group using a wearable TENS device, exercise group performing designated exercises, and combined group performing activities from the TENS and exercise groups. Main Outcome MeasuresThe primary outcome measure was PA. The secondary outcome measures were 6-minute walk test (6MWT); timed Up and Go (TUG) test; stair climbing; knee pain using the visual analog scale at 6MWT, TUG test, and stair climbing; and patient-reported changes in knee pain over time. ResultsAt pre- and postintervention, light-intensity PA time (minutes per day) in the TENS, exercise, and combined groups was 735.62±68.82 vs 714.21±73.06 (P=.061), 733.05±103.90 vs 700.31±90.33 (P=.057), and 710.09±62.98 vs 685.22±58.35 (P=.049), respectively, with a significant decrease in the combined group. Significant improvement in knee pain and stair climbing was observed in all groups pre- and postintervention. ConclusionsThe group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light-intensity activities such as sedentary behavior. Thus, the use of TENS in combination with conventional exercise therapy has the potential to reduce psychological barriers to the introduction of exercise therapy. It also promotes and ensures the safe implementation and continuation of exercise therapy.

Motivating Physical Activity with a Walking Exercise Behaviour Intervention and Pain Management Remotely in Intermittent Claudication (MAvERIC): protocol for a randomised controlled feasibility trial

Background: Physical activity (PA) through walking exercise improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). However, there are many barriers to uptake and maintenance of PA in this population including pain and limited motivation. The aim of this study is to test the feasibility and acceptability of delivering a clinical trial to evaluate the effect of using a walking exercise behaviour change intervention, modified to include the use of a transcutaneous electrical nerve stimulation (TENS) device for non-invasive pain management, to increase walking-based PA in individuals with PAD and IC in comparison with usual care. Methods: This is a randomised controlled analysis-blinded feasibility study with two parallel groups. We will recruit 48 adults with PAD and IC from NHS Lanarkshire vascular service. Inclusion criteria are: PAD (ankle brachial pressure index <0.90) and stable IC for >3 months, being able and willing to participate, and to provide informed consent. Participants will be randomly assigned 1:1 to intervention plus usual care or usual care alone. Usual care includes best medical therapy, information on PAD, walking advice or home exercise programme, and managing risk factors. The intervention consists of a home-based, walking exercise behaviour change intervention (MOSAIC), adapted for remote delivery, and includes non-pharmacological pain management through a TENS device. Feasibility and exploratory outcomes will be assessed at baseline, after 6 and 12 weeks of intervention, and at 6 and 12 months follow-up. The primary outcomes are trial process and intervention feasibility, as well as intervention acceptability measured using rates of participant recruitment and retention, intervention adherence, and the Theoretical framework of Acceptability questionnaire. Exploratory outcomes include daily PA and patient-reported outcomes including quality of life, pain self-efficacy and catastrophising, and walking impairment pain intensity and quality. Conclusion: This trial will evaluate the feasibility and acceptability of a remotely delivered walking exercise behaviour change intervention adapted to include the use of a TENS device to improve PA in individuals with PAD and IC. Trial Registration Number: ClinicalTrials.gov Identifier: NCT06114732

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30 to 60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor-blinded randomized clinical trial (RCT) was designed to assess 1) preliminary efficacy (ie, alpha pre-specified at .2) of a wearable, app-controlled, transcutaneous electrical nerve stimulation (TENS) device for chronic CIPN and 2) feasibility of conducting a confirmatory trial within the National Cancer Institute Community Oncology Research Program (NCORP) (NCT 04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0–10 numeric rating scales). The primary analysis was an analysis of covariance (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used a similar analysis of covariance models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at the endpoint (placebo-active) was 1.05 (95% Confidence Interval: −.56, 2.67; P = .199). The difference between groups for the individual symptoms was as follows: hot/burning pain: 1.37 (−.33, 3.08; P = .112), sharp/shooting pain: 1.21 (−.37, 2.79; P = .128), cramping: 1.35 (−.32, 3.02; P = .110), tingling: .23 (−.61, 1.08; P = .587), numbness: .27 (−.51, 1.05; P = .492). An RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in the NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PerspectiveDaily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.

Salivary stimulatory effect of novel low level transcutaneous electro neurostimulator in geriatric patients with xerostomia

BackgroundXerostomia (dryness of the mouth) is one of the most common long-term consequences of ageing, and it causes a tremendous impact on the function and morphology of the salivary ductal system. As a consequence, it leads to a decrease in the amount of salivary output and also affects the overall quality of life. The purpose of this study was to determine whether electrostimulation using a custom designed transcutaneous electrical nerve stimulation (TENS) device will help to improve the quality of secreted saliva following electrostimulation.MethodsOne hundred thirty-five participants underwent the intervention for three months, twice daily (80 Hz). Pre-intervention and post-intervention unstimulated saliva were collected. Parameters such as salivary pH, cortisol level, salivary antioxidants, total protein, the viscosity of saliva, and microbial carriage were analysed.ResultsSalivary pH, cortisol, microbial cultures, viscosity, and antioxidants showed a significant difference at the end of the 3rd month (p < 0.05). Irrespective of the patient's age, gender, and common underlying systemic illnesses (diabetes and hypertension), a significant change in the quality of the salivary analytes was observed.ConclusionThe study emphasises the use of a custom designed TENS device in improving the quality of secreted saliva among old patients with oral dryness.

The effects of cold compress and transcutaneous electrical nerve stimulation on the pain associated with chest tube removal among patients with coronary bypass grafting

Background and aimChest tube removal (CTR) can cause severe acute pain which is usually described by patients as a painful experience. This study compared the effects of cold compress, transcutaneous electrical nerve stimulation (TENS), and combined cold compress-TENS on CTR-associated pain among patients with coronary artery bypass grafting (CABG).MethodsThis randomized controlled trial was conducted in 2018–2019 using a double-blind four-group design. Participants were 120 patients with CABG selected from Shafa hospital, Kerman, Iran, and randomly allocated to a cold compress, a TENS, a combined cold compress-TENS, and a placebo group (compress with room temperature) and TENS with an off TENS device. Each participant received the intervention for 15 min immediately before CTR. CTR-associated pain was assessed before, during, immediately after, and 15 min after CTR. Data were analyzed using the SPSS program (v. 22.0) at a significance level of less than 0.05.ResultsThe data of 29 participants in the placebo group, 26 in the TENS group, 30 in the cold compress group, and 26 in the combined cold compress-TENS group was gathered. Baseline demographic and clinical characteristics and pain intensity scores of participants had no statistically significant differences among all four groups (P > 0.05). The mean score of pain intensity in all groups was at its highest level during CTR and gradually decreased afterwards, but this pain intensity reduction in the compress-TENS group was significantly greater than other groups (P < 0.001).ConclusionCombined cold compress-TENS is more effective than separate cold compress and TENS in reducing CTR-associated pain among patients with CABG. Therefore, non-pharmacological methods such as combined cold compress-TENS are recommended for managing CTR-associated pain.

Transcutaneous electrical nerve stimulation reduces acute pain, and the use of analgesics after ankle fracture surgery

Objective: To evaluate the applicability of transcutaneous electrical nerve stimulation (TENS) as a complementary treatment method to non-opioid analgesics for acute postoperative pain in patients undergoing surgical treatment due to ankle fractures. Methods: A prospective, randomized, analytical, cross-sectional study performed after ankle fracture surgery. Two groups were randomized as follows: group 1 (Intervention) received TENS and non-opioid analgesic (dipyrone), and group 2 (Control) received non-opioid analgesic (dipyrone). Results: This study demonstrated that TENS in patients undergoing surgical treatment of ankle fractures reduces the use of rescue opioids significantly to control postoperative pain. Conclusion: TENS devices may be another safe option to control postoperative pain and reduce the use of opioids, avoiding adverse effects from this class of analgesic. Level of Evidence II; Therapeutic Studies; Prospective Comparative Study.

Effect of Transcutaneous Electrical Nerve Stimulation Device on Pain Intensity among Female Students during Primary Dysmenorrhea

Effect of Transcutaneous Electrical Nerve Stimulation Device on Pain Intensity among Female Students during Primary Dysmenorrhea

Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo.

This randomized, crossover, double-blind, controlled trial evaluates the efficacy and safety of a preprogrammed transcutaneous electrical nerve stimulation (TENS) device versus placebo (SHAM) in women with primary dysmenorrhea (PD). Forty women suffering from significant dysmenorrhea requiring the use of analgesics and/or non-steroidal anti-inflammatory drugs self-apply to the abdominal or lumbar region depending on the location of the pain, alternately according to randomization, the TENS device then the SHAM (dummy device) or conversely SHAM then TENS. The primary endpoint compares the evolution of pain intensity before and after application of TENS and SHAM. The speed of action, the persistence of the analgesic effect and the therapeutic savings are also evaluated. Adverse events (AEs) are collected. A statistically and clinically significant decrease in the pain of 53% (P<0.0001) is observed during the first 2 applications of TENS versus no analgesic effect (-5%, P=0.318) with SHAM. Over all 197 applications of TENS, the reduction of menstrual pain intensity by more than half is confirmed. The rapid relief, less than 20 minutes in 74% of cases, lasts on average more than 7 hours. A difference in analgesic consumption of -93% is observed in favor of TENS (P<0.01). Seven participants reported 10 non-serious AEs, 2 of which were possibly related to TENS. The TENS device tested represents a well-tolerated, rapidly and lastingly effective non-pharmacological analgesic solution, capable of replacing or being combined with analgesics in the management of PD.

Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial

ObjectivesThis study investigated the efficacy of a transcutaneous electrical nerve stimulation (TENS) device (Quell®) for persons with symptoms due to fibromyalgia (FM). Materials and MethodsOne hundred nineteen (N = 119) subjects were randomly assigned to use an active (N = 62) or sham (N = 57) TENS for three months. All subjects completed baseline questionnaires and were administered quantitative sensory testing (QST). Subjects completed the Patients' Global Impression of Change (PGIC, primary outcome measure) and other mailed questionnaires (secondary outcome measures) at six weeks and three months. ResultsThe subjects averaged 50.4 ± 13.5 years of age, 93.3% were female, and 79.8% were Caucasian. Most showed benefit from using the TENS, but no differences between groups were found on the primary outcome measure after three months (active 3.87 ± 1.85, sham 3.73 ± 1.80, 95% confidence interval [CI] [−0.60, 0.88], p = 0.707). Those with more hypersensitivity showed most improvement on the PGIC at six weeks (0.22, 95% CI [0.01, 0.43], p = 0.042) and three months (0.20, 95% CI [0.00, 0.41], p = 0.049) and among those with higher sensitivity based on QST, the active TENS group showed the most benefit with TENS compared with the sham treatment (1.20, 95% CI [0.22, 2.18], p = 0.017). No TENS-related serious adverse events were reported. Subjects in the sham group correctly identified their treatment 87.5% of the time, while, surprisingly, subjects in the active group correctly identified their treatment only 17.4% of the time. ConclusionThis study found no differences between those who were exposed to maximal-frequency active stimulation or minimal-frequency sham stimulation from a wearable TENS in reducing FM-related symptoms. However, those with greater hypersensitivity showed most benefit from TENS. Additional studies to help determine the role individual differences play in the use of TENS in managing FM-related symptoms are needed.

The Effects of Transcutaneous Vagal Nerve Stimulation on Dynamic Cerebral Autoregulation

PurposeTranscutaneous vagal nerve stimulation (tVNS) applied to the cervical branch of the vagus nerve is FDA‐approved to treat migraine and cluster headache. tVNS applied to the auricle branch of the vagus nerve (tVNSab) reduces muscle sympathetic nerve activity and improves cardiac parasympathetic activity after one session in healthy participants. Given the use of tVNS to treat cerebral disorders and its effects on autonomic function, we postulated that tVNSab might be beneficial for cerebral vascular function. We tested the hypotheses that tVNSab will increase resting middle cerebral artery blood flow velocity (MCAv) and improve dynamic cerebral autoregulation (dCA) during a repeated squat‐to‐stand procedure.MethodsSeven healthy participants (age: 20 ± 3 y; BMI:19 ± 7 kg/m2; 3 women) completed two randomized experimental visits on separate days. One visit consisted of tVNSab using a transcutaneous electrical nerve stimulation device (pulse width = 200 ms; pulse frequency = 30 Hz) with electrodes attached to the tragus of each ear. A time‐control visit (SHAM) was conducted with electrodes attached to the tragus but no current was applied. Mean arterial pressure (MAP; photoplethysmography), the partial pressure of end‐tidal carbon dioxide (PETCO2; capnography) and MCAv (transcranial Doppler ultrasound) were measured continuously. After 45 min of resting tVNS or SHAM, subjects performed a repeated squat‐to‐stand maneuver at a frequency of 0.05 Hz for 5 min while tVNSab or SHAM continued. Resting conductance values for the MCA (MCAc) were calculated as MCAv/MAP. MCA dCA was assessed during the squat‐to‐stand maneuver using spectral analyses to obtain coherence, gain, and phase values in the very low frequency (VLF) and low frequency (LF) bands. Spectral analysis gain was also assessed using normalized units (gainn), defined as beat to beat values divided by the mean value relative to changes in blood pressure. Data are presented as mean ± SD.ResultsThere were no differences between tVNSab and SHAM for MAP (tVNSab: 103 ± 8; SHAM: 102 ± 12 mmHg; P=0.41), PETCO2 (tVNSab: 35 ± 5; SHAM: 36 ± 2 mmHg; P=0.42), MCAv (tVNSab: 61.5 ± 9.2; SHAM: 58.7 ± 13.3 cm/s, P=0.36) or MCAc (tVNSab: 0.60 ± 0.08; SHAM: 0.59 ± 0.19 cm/s/mmHg, P=0.46) during baseline. There were no differences between conditions for coherence at VLF (tVNSab: 0.43 ± 0.14; SHAM: 0.45 ± 0.34; P=0.44) or LF (tVNSab: 0.65 ± 0.17; SHAM: 0.72 ± 0.13; P=0.06). Phase in the VLF (tVNSab: 0.35 ± 0.32; SHAM: 0.33 ± 0.36 rad; P=0.44) and LF (tVNSab: 0.28 ± 0.23; SHAM: 0.30 ± 0.16 rad; P=0.36) were not different. Gain (tVNSab: 0.56 ± 0.30; SHAM: 0.56 ± 0.54 cm/s/mmHg; P=0.50) and gainn (tVNSab: 0.99 ± 0.53; SHAM: 0.85 ± 0.84 %/mmHg; P=0.37) in the VLF were not different. However, gain (tVNSab: 0.76 ± 0.14; SHAM: 0.86 ± 0.17 cm/s/mmHg; P=0.02) and gainn (tVNSab: 1.22 ± 0.16; SHAM: 1.35 ± 0.23 %/mmHg; P=0.04) in the LF were lower during tVNSab.ConclusiontVNSab did not alter resting cerebral vascular responses. However, MCA LF gain was lower during tVNSab versus SHAM. These preliminary data indicate that dCA in a major intracranial cerebral artery might be improved during a single session of tVNSab. Further research regarding the influence of chronic tVNSab on cerebral vascular function is warranted.

Microvolt T-Wave Alternans Is Modulated by Acute Low-Level Tragus Stimulation in Patients With Ischemic Cardiomyopathy and Heart Failure.

Aims: Microvolt T-wave alternans (TWA), an oscillation in T-wave morphology of the electrocardiogram (ECG), has been associated with increased susceptibility to ventricular tachy-arrhythmias, while vagus nerve stimulation has shown promising anti-arrhythmic effects in in vivo and ex vivo animal studies. We aimed to examine the effect of non-invasive, acute low-level tragus stimulation (LLTS) on TWA in patients with ischemic cardiomyopathy and heart failure.Methods: 26 patients with ischemic cardiomyopathy (left ventricular ejection fraction <35%) and chronic stable heart failure, previously implanted with an automatic implantable cardioverter defibrillator (ICD) device with an atrial lead (dual chamber ICD or cardiac resynchronization therapy defibrillator), were enrolled in the study. Each patient sequentially received, (1) Sham LLTS (electrode on tragus, but no stimulation delivered) for 5 min; (2) Active LLTS at two different frequencies (5 and 20 Hz, 15 min each); and (3) Active LLTS, during concomitant atrial pacing at 100 bpm at two different frequencies (5 and 20 Hz, 15 min each). LLTS was delivered through a transcutaneous electrical nerve stimulation device (pulse width 200 μs, frequency 5/20 Hz, amplitude 1 mA lower than the discomfort threshold). TWA burden was assessed using continuous ECG monitoring during sham and active LLTS in sinus rhythm, as well as during atrial pacing.Results: Right atrial pacing at 100 bpm led to significantly heightened TWA burden compared to sinus rhythm, with or without LLTS. Acute LLTS at both 5 and 20 Hz, during sinus rhythm led to a significant rise in TWA burden in the precordial leads (p < 0.05).Conclusion: Acute LLTS results in a heart-rate dependent increase in TWA burden.

Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial.

PurposeFibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia.Patients and MethodsAdults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model.ResultsNo differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [−0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (−7.47, 95% CI [−12.46, −2.48], p=0.003), FIQR pain item (−0.62, 95% CI [−1.17, −0.06], p=0.029), BPI Interference (−0.70, 95% CI [−1.30, −0.11], p=0.021) and PDQ (−1.69, 95% CI [−3.20, −0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups.ConclusionThis study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia.Clinicaltrials.gov RegistrationNCT03714425.

Design of a TENS knee pad with integrated textile electrodes

Transcutaneous electrical nerve stimulation (TENS) is defined as the application of electrical current to the skin for paincontrol by the American Physical Therapy Association (APTA). The TENS treatment is extensively preferred since it issafe, not expensive and has no side effects when compared to drug therapy. TENS therapy is applied using clinical orportable type TENS devices and TENS electrodes. However, conventional electrodes are not hygienic because they arenot washable and their sticky structure makes patients uncomfortable. Furthermore, they are not suitable to beintegrated into a smart garment. In this study, a knee pad with integrated electrodes and textile transmission lines havebeen designed and developed to be used for TENS therapy. Electrical resistance values of textile electrodes andtransmission lines which are integrated into the knee pad were measured. The developed knee pad was connected toa commercially available TENS device and electrical current transmission on subjects was tested. Furthermore, washingtests were conducted on the knee pad.

Analgesic efficacy of a portable, disposable, and self-applied transcutaneous electrical nerve stimulation device during migraine attacks: A real-life randomized controlled trial.

The objective of this study was to evaluate the analgesic efficacy of a portable, disposable, and home self-applied transcutaneous electrical nerve stimulation (TENS) device during migraine attacks. TENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks. A double-blind, randomized controlled trial was conducted over 3months, with monthly assessments. Active placebos (sham group) were in place and were allocated at a 1:1 ratio. Adult patients who had been diagnosed with migraine by a specialist were included. Pain intensity levels and functional disability were measured before and after the 20-min self-applied TENS intervention during the migraine attacks. Seventy-four participants were randomly allocated to the sham and intervention groups. Although both groups of subjects reported lower pain scores, the intervention group showed a statistically significant reduction in pain scores compared to the sham group. In our controlled trial, the use of a self-applied, TENS device is safe and effective in relieving pain associated with migraine attacks. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores. TENS has been used as a noninvasive treatment for migraine, but there are no reports on the outcomes following use of this treatment option for use at home during migraine attacks. This double-blind, randomized controlled trial had 2 groups: active-placebo and intervention. Seventy-four participants were randomly allocated. Participants in the intervention group showed a statistically significant improvement in pain and functional disability scores.

Low-Level Tragus Stimulation Modulates Atrial Alternans and Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation.

BackgroundLow‐level tragus stimulation (LLTS) has been shown to significantly reduce atrial fibrillation (AF) burden in patients with paroxysmal AF. P‐wave alternans (PWA) is believed to be generated by the same substrate responsible for AF. Hence, PWA may serve as a marker in guiding LLTS therapy. We investigated the utility of PWA in guiding LLTS therapy in patients with AF.Methods and ResultsTwenty‐eight patients with AF were randomized to either active LLTS or sham (earlobe stimulation). LLTS was delivered through a transcutaneous electrical nerve stimulation device (pulse width 200 μs, frequency 20 Hz, amplitude 10–50 mA), for 1 hour daily over a 6‐month period. AF burden over 2‐week periods was assessed by noninvasive continuous ECG monitoring at baseline, 3 months, and 6 months. A 5‐minute control ECG for PWA analysis was recorded during all 3 follow‐up visits. Following the control ECG, an additional 5‐minute ECG was recorded during active LLTS in all patients. At baseline, acute LLTS led to a significant rise in PWA burden. However, active patients receiving chronic LLTS demonstrated a significant reduction in both PWA and AF burden after 6 months (P<0.05). Active patients who demonstrated an increase in PWA burden with acute LLTS showed a significant drop in AF burden after 6 months of chronic LLTS.ConclusionsChronic, intermittent LLTS resulted in lower PWA and AF burden than did sham control stimulation. Our results support the use of PWA as a potential marker for guiding LLTS treatment of paroxysmal AF.

Resolving Long-Standing Uncertainty about the Clinical Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) to Relieve Pain: A Comprehensive Review of Factors Influencing Outcome.

Pain is managed using a biopsychosocial approach and pharmacological and non-pharmacological treatments. Transcutaneous electrical nerve stimulation (TENS) is a technique whereby pulsed electrical currents are administered through the intact surface of the skin with the intention of alleviating pain, akin to ‘electrically rubbing pain away’. Despite over 50 years of published research, uncertainty about the clinical efficacy of TENS remains. The purpose of this comprehensive review is to critically appraise clinical research on TENS to inform future strategies to resolve the ‘efficacy-impasse’. The principles and practices of TENS are described to provide context for readers unfamiliar with TENS treatment. The findings of systematic reviews evaluating TENS are described from a historical perspective to provide context for a critical evaluation of factors influencing the outcomes of randomized controlled trials (RCTs); including sample populations, outcome measures, TENS techniques, and comparator interventions. Three possibilities are offered to resolve the impasse. Firstly, to conduct large multi-centered RCTs using an enriched enrolment with randomized withdrawal design, that incorporates a ‘run-in phase’ to screen for potential TENS responders and to optimise TENS treatment according to individual need. Secondly, to meta-analyze published RCT data, irrespective of type of pain, to determine whether TENS reduces the intensity of pain during stimulation, and to include a detailed assessment of levels of certainty and precision. Thirdly, to concede that it may be impossible to determine efficacy due to insurmountable methodological, logistical and financial challenges. The consequences to clinicians, policy makers and funders of this third scenario are discussed. I argue that patients will continue to use TENS irrespective of the views of clinicians, policy makers, funders or guideline panel recommendations, because TENS is readily available without prescription; TENS generates a pleasant sensory experience that is similar to easing pain using warming and cooling techniques; and technological developments such as smart wearable TENS devices will improve usability in the future. Thus, research is needed on how best to integrate TENS into existing pain management strategies by analyzing data of TENS usage by expert-patients in real-world settings.

The Effect of Transcutaneous Electric Nerve Stimulation (TENS) on Anxiety and Fear in Children Aged 9-14 Years.

IntroductionDental fear or dental phobia is caused by previous unpleasant dental experiences and pain. It can result in delaying or avoiding dental visits. Most often it leads to individuals avoiding visiting the dentist until physical pain completely impairs the quality of life.ObjectivesTranscutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current. The main aim of this study was to examine whether the TENS device affects the reduction of anxiety and fear during dental procedures.Material and MethodsThe study was conducted on a sample of 125 respondents, aged 9-14 years. Statistical significance of differences between pre- and post-treatment results on all applied measuring instruments was verified by the t-test for dependent samples. The calculation was performed for all respondents and individually for the three observed groups. The Children`s Fear Survey Schedule – Dental Subscale test was used to assess anxiety and fear.ResultsThe results on the CFSS-DS scale in all subjects did not differ statistically significantly before and after treatment (p > 0.05). The results on the CFSS-DS scale in subjects who received TENS were statistically significantly different before and after treatment (p < 0.01). The results on the CFSS-DS scale in subjects who received local anesthesia were statistically significantly different before and after treatment (p < 0.05).ConclusionThe TENS device had an anxiolytic effect after the first visit.

Transcutaneous Electrical Nerve Stimulation for the Long-Term Treatment of Ocular Pain

Ocular pain is a debilitating condition that is challenging to treat as therapies that target the ocular surface are often ineffective. We previously reported a short-term reduction in ocular pain after one periocular transcutaneous electrical nerve stimulation (TENS) session. The current study aims to elucidate the long-term effect of TENS on ocular pain. Fourteen individuals with eye pain were identified as candidates for a TENS device (RS Medical, Vancouver) for home use after a successful trial in clinic between February 2018 and July 2019 at the Miami Veterans Administration Hospital or University of Miami. Ten of the 14 patients were included in this retrospective review, based on the inclusion of receiving and using the device for a minimum of three months. The median age of the ten patients was 47.5 years, range 32-73 years, and eight were male. The main outcome measures were 1) frequency of long-term integration of TENS into ocular pain management and 2) patient reported ocular pain intensity (0-10) pre- vs. post-treatment. Patients reported an initial median use of the device 14.0 times per week and over time reducing the frequency to 3.0 times per week. All reported that the TENS unit was successfully incorporated into their ocular pain management routine for at least three months (median duration of use 6.5 months, range 3-14 months). Nine of ten patients reported subjective pain reduction with use of the TENS device at home. Overall, pain intensity decreased by approximately 27.4% (mean rank = 5.6, Z = -2.1, p = 0.02) post- vs. pre-treatment. No adverse events associated with TENS were reported in any patient. Our preliminary data suggest that TENS can be integrated into the long-term management of ocular pain with improvements in overall pain intensity.