Placebo Transcutaneous Electrical Nerve Stimulation Research Articles

Efficacy of Myofascial Release With Transcutaneous Electrical Nerve Stimulation Conductive Glove for Neck Myofascial Syndrome: A Randomized Clinical Trial Study

ObjectiveThe purpose of this study was to assess the efficacy of a myofascial release (MR) protocol applied with a transcutaneous electrical nerve stimulation (TENS) conductive glove. MethodsEighty individuals with neck myofascial syndrome were randomly divided into 4 groups: (1) MR protocol with a TENS conductive glove (MR+TENS), (2) MR protocol without TENS (MR), (3) conventional TENS protocol (TENS), and (4) placebo TENS (control). All participants attended 6 sessions over a period of 3 weeks. The following measures were evaluated at baseline, at the third week, and at the 1-month follow-up: Pain with the visual analog scale (VAS pain), upper trapezius pressure pain threshold (PPT) with pressure algometry, cervical range of motion (ROM) with goniometry, and disability with the neck disability index (NDI). A 2-way ANOVA with repeated measurements was applied. ResultsSignificant changes between the 3 intervention groups and the control group were noted in the VAS and the NDI scores (P < .05) with the MR+TENS group exhibiting the biggest difference. Additionally, MR significantly increased PPT compared to TENS, and even further when applied with the conductive glove (P < .05). Regarding lateral flexion ROM, MR was equally effective either alone or in combination with the glove compared to TENS (P < .05). In contrast, TENS did not appear to affect neck PPT and ROM (P > .05). Finally, no difference between the groups was detected in cervical rotation ROM (P > .05). ConclusionThe MR protocol appears to be more effective in dealing with pain, disability, and lateral flexion ROM than conventional TENS. A TENS conductive glove significantly improves the effects of MR, possibly due to the combined mechanical and electrical stimulation of the muscle.

The effect of transcutaneous electrical nerve stimulation on lumbar range of motion and lumbar fascia characteristics in healthy individuals

ObjectivesTo investigate the effect of Transcutaneous electrical nerve stimulation (TENS) on lumbar fascia thickness, lumbar flexion angle, and lumbar curvature in healthy people. DesignRandomized, clinical trial. Subjects100 healthy individuals. InterventionsParticipants were randomized into the active TENS group (n = 50) and placebo TENS group (n = 50). Subjects received 10 sessions of TENS in the lumbar region for 2 weeks. Main measuresLumbar fascia thickness, lumbar flexion angle, and lumbar curvature examined by ultrasonography, flexible ruler, and spinal mouse three times (before and after the intervention sessions, and two weeks after the last intervention session-follow up) ResultsSubjects in the TENS group showed a significant reduction in lumbar fascia thickness (P ≤ 0.002), an increase in lumbar flexion angle (P = 0.000), and an increase in lumbar curvature angle (P = 0.000) before and after the intervention sessions. The results of the follow-up evaluations showed the stability of the changes in the mentioned variables. ConclusionThe improvements in the lumbar fascia thickness and lumbar flexibility suggest that TENS may be effective in healthy subjects. Data indicate that biomechanical properties of lumbar fascia and lumbar flexibility are directly linked, and other mechanisms could be more influential in contributing to improvement.

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

BackgroundLow 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov NCT05812885. Registered on 24th May 2023.

An algorithm for the use of various transcutaneous electrical nerve stimulation modalities in treatment of patients with residual positive sensory symptoms after surgical decompression of the carpal tunnel

BACKGROUND: The main cause of residual neurological symptoms after surgical carpal tunnel decompression is long-term compressive neuropathy of the median nerve in the carpal tunnel in the preoperative period. As a result, irreversible morphological and neurophysiological changes gradually develop on the part of the compressed median nerve, which may not recover after its decompression. AIM: To establish an algorithm for the use of transcutaneous electrical nerve stimulation (TENS) of various modalities in the treatment of patients with residual neurological symptoms after undergoing surgical carpal tunnel decompression. MATERIALS AND METHODS: We observed 100 patients with residual positive symptoms after undergoing successful of surgical decompression of the carpal tunnel. The control group consisted of 20 patients (10 women and 10 men) and underwent a 2-month course of standard drug therapy. The main group (n=80), in addition to the standard drug therapy carried out in the control group, underwent a course of TENS, which began on the 2nd month of drug treatment. Depending on the form of TENS therapy, patients of the main group were divided into 4 subgroups: the TENS placebo subgroup (n=20) underwent a course of ineffective TENS. High-frequency TENS subgroup (n=20) completed a course of high-frequency low-amplitude TENS. Low-frequency TENS subgroup (n=20) completed a course of low-frequency high-amplitude TENS. The high-frequency TENS + low-frequency TENS subgroup underwent a simultaneous course of high-frequency TENS and low-frequency TENS (n=20). Positive sensory symptoms of numbness, tingling, burning and a feeling of electric charge were rated by the patients themselves over the past 24 hours on a 10-point scale. RESULTS: When comparing the subgroups of effective TENS (high-frequency TENS, low-frequency TENS, high-frequency TENS + low-frequency TENS) with the subgroup of ineffective TENS (placebo), a significant decrease in positive sensory symptoms was revealed in the subgroups of high-frequency TENS, low-frequency TENS, high-frequency TENS and low-frequency TENS by 112%, 40% and 163% respectively. When comparing the effectiveness of high-frequency TENS and low-frequency TENS with each other, it was possible to establish that high-frequency TENS exceeds the efficiency of low-frequency TENS by almost 2 times. However, the combination of low-frequency TENS with high-frequency TENS enhances the therapeutic effect of the latter by 46%. CONCLUSION: The use of high-frequency TENS is recommended in the treatment of patients with residual positive sensory symptoms. For strong positive sensory symptoms with the development of secondary affective reactions, it is recommended to combine high-frequency TENS and low-frequency TENS to enhance the effect.

Influence of Transcutaneous Electrical Nerve Stimulation (TENS) on Pressure Pain Thresholds and Conditioned Pain Modulation in a Randomized Controlled Trial in Women With Fibromyalgia

Transcutaneous electrical nerve stimulation (TENS) effectively reduces pain in fibromyalgia (FM). The purpose of this study was to examine the influence of TENS use on pressure pain thresholds (PPT) and conditioned pain modulation (CPM) in individuals with FM using data from the Fibromyalgia Activity Study with TENS trial (NCT01888640). Individuals with FM were randomly assigned to receive active TENS, placebo TENS, or no TENS for 4 weeks. A total of 238 females satisfied the per-protocol analysis among the active TENS (n = 76), placebo TENS (n = 68), and no TENS (n = 94) groups. Following 4 weeks of group allocation, the active TENS group continued for an additional 4 weeks of active TENS totaling 8 weeks (n = 66), the placebo and no TENS groups transitioned to receive 4 weeks of active TENS (delayed TENS, n = 161). Assessment of resting pain, movement-evoked pain (MEP), PPT, and CPM occurred prior to and following active, placebo, or no TENS. There were no significant changes in PPT or CPM among the active TENS, placebo TENS, or no TENS groups after 4 weeks. Individuals who reported clinically relevant improvements in MEP (≥30% decrease) demonstrated increases in PPT (P < .001), but not CPM, when compared to MEP non-responders. There were no significant correlations among the change in PPT or CPM compared to MEP and resting pain following active TENS use (active TENS + delayed TENS). PPT and CPM may provide insight to underlying mechanisms contributing to pain; however, these measures may not relate to self-reported pain symptoms. PerspectivePressure pain threshold increased in individuals with clinically relevant improvement (≥30%) in MEP, indicating the clinical relevance of PPT for understanding mechanisms contributing to pain. CPM was not a reliable indicator of treatment response in MEP responders.

Evaluation of the role of transcutaneous electrical nerve stimulation for postoperative pain relief in laparoscopic cholecystectomy: a prospective comparative study

BackgroundPostoperative pain after laparoscopic cholecystectomy still remains a fairly common challenge for the anesthesiologist. Commonly used drugs such as NSAIDs and opioids have their own side effects requiring a need to substantially evaluate the use of non-pharmacological methods like TENS as adjuvants to conventional methods of pain control. We studied the effect of transcutaneous electrical nerve stimulation (TENS) on postoperative pain in laparoscopic cholecystectomy. The primary objective was to compare postoperative analgesia between TENS and placebo groups using visual analog scale (VAS). The secondary objectives were to compare the requirement and dosage of rescue analgesia, hemodynamic parameters (blood pressure and heart rate), and incidence of nausea and emesis between placebo and TENS groups. A total of 64 patients of age group 18 years to 60 years of either gender posted for elective laparoscopic cholecystectomy were randomly allocated into two groups using a computer-generated sequence of random numbers: Group P (n= 32): placebo TENS and Group A (n= 32): active TENS. Statistical analysis was performed by the SPSS program for Windows, version 17.0 (SPSS, Chicago, Illinois). Unpaired t test, Mann-Whitney U test, chi-square test, and Fisher’s exact test were used for statistical analysis.ResultsThe two groups were statistically similar in terms of age, gender, and weight. The VAS scores were significantly lower in patients in the active TENS group for up to 2 h after surgery, and the total weighted dose of diclofenac consumed over 8 h in the active TENS group was significantly lower as compared to the placebo TENS group. Patients who received TENS showed significantly less rise in blood pressure and heart rate and remained hemodynamically stable. Total episodes of nausea and emesis though less in the active TENS group were statistically insignificant.ConclusionWe conclude that TENS is an effective adjuvant non-pharmacologic modality for postoperative pain relief after laparoscopic cholecystectomy.

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.

The effects of transcutaneous electrical nerve stimulation on muscle activity pattern in professional voice users with muscle tension dysphonia using surface electromyography data: A pilot study

ObjectivesMuscle Tension Dysphonia is a voice disorder, which results in stiffness in the laryngeal extrinsic muscles, intense collision, painful contractions, and vibrations of the vocal cords. Due to the multifactorial identity of Muscle Tension Dysphonia, its therapeutic approach must be multidisciplinary. MethodsThe participants were divided into two groups: a control group (5participants) that received Circumlaryngeal Manual Therapy (CMT) + Placebo Transcutaneous Electrical Nerve Stimulation and an experimental group (5participants) that received Transcutaneous Electrical Nerve Stimulation + CMT. Both groups received 10 sessions of treatment, twice a week, for 40 min each. Before and after treatment, participants were assessed using the Dysphonia Severity Index (DSI) and surface electromyography for their ability to sustain the vowels /e& u/and count from 20 to30. ResultAfter therapy, there were substantial improvements in the DSI (2.72 ± 0.55, P < 0.05) and muscle electrical activity in the control group. The DSI (3.66 ± 0.63, P < 0.05) and muscle electrical activity were also significantly improved in the experimental group after treatment. The findings of the between-group comparison after treatment revealed a significantly greater increase in the Dysphonia Severity Index in the experimental group compared with the control group (P = 0.037). Although there was no significant difference between the two groups in terms of muscle electrical activity, clinically significant changes were more noticeable in the experimental group when compared with the control group. ConclusionsPositive results were seen in both groups. The results demonstrate that both approaches relax vocal tract muscles. As a result, Transcutaneous Electrical Nerve Stimulation was recommended as a complementary treatment for clients with Muscle Tension Dysphonia.

Can Vocal Therapy With Transcutaneous Electrical Nerve Stimulation (TENS) Followed by Vocal Exercises Reduce Benign Laryngeal Lesions in Dysphonic Women?: Randomized, Blind Clinical Trial

To investigate the effectiveness of vocal therapy with the use of low-frequency transcutaneous electrical nerve stimulation (TENS) followed by voice exercises on vocal fold lesion size, vocal quality and quality of life in dysphonic women. 27 women with vocal nodules participated, randomized into to: experimental group (EG)-13 women who received vocal therapy with 12 sessions of 20 min of TENS application (pulse:200μs, frequency:10Hz, motor threshold intensity, electrodes positioned in the trapezius muscle [descending fibers and submandibular region, bilaterally]). Each TENS session was followed by 30 min of vocal exercises; and the Control Group (CG)- 14 women who received 12 sessions with 20 min of application of placebo TENS (same conditions EG, but without receiving the stimulus electric), followed by 30 min of vocal exercise. Before, immediately after and one month after vocal therapy, participants underwent vocal recording for acoustic analysis, vocal self-assessment, laryngological examination and answered voice-related quality of life (V-RQOL) protocol. There was reduction in the size of vocal fold lesions only in the EG, immediately after treatment and one month after treatment. Acoustic analysis showed decreases in SPI values immediately after and one month after treatment in both groups. There was improvement in voice self-perception in both groups after treatment and one month after, but no significant difference in V-RQOL values. TENS followed by vocal exercises produced results similar to vocal therapy without TENS regarding voice quality, self-perception and quality of life in voice. However, vocal therapy with low-frequency TENS followed by vocal exercise was effective in reducing vocal fold lesion size in dysphonic women.

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial.

To evaluate whether transcutaneous electrical nerve stimulation (TENS) reduces opioid use after cesarean birth. We conducted a randomized, double-blind, placebo-controlled trial of TENS after cesarean birth, with the primary outcome of opioid use during the first 60 hours postoperatively. Secondary outcomes included pain scores and satisfaction with pain control on each postoperative day, duration of postoperative hospitalization, and adverse effects of TENS. We estimated 60 patients in each arm for 80% power to detect a 25% decrease in opioid use, assuming 10% attrition. To assess for a placebo effect, an additional 60 patients were randomized to no TENS during recruitment for secondary analyses comparing opioid use, pain scores, and pain control satisfaction between no TENS and placebo TENS. Analysis was by intention-to-treat. From January 2020 through March 2021, we enrolled 180 participants-60 per group. Baseline characteristics were similar across groups. Median (interquartile range) opioid consumption in the first 60 hours postoperatively, in morphine milligram equivalents, was 7.5 (0-30) with active TENS and 0 (0-22.5) with placebo TENS (P=.31). There were no significant differences in pain scores, satisfaction with pain control, or postoperative length of stay. In the no TENS group, median (interquartile range) opioid consumption in the first 60 hours postoperatively was 7.5 (0-21.9), similar to that in the placebo group (P=.57). There were also no significant differences in pain scores or pain control satisfaction between participants allocated to no TENS and those allocated to placebo TENS. Use of TENS after cesarean birth did not change hospital opioid consumption, pain scores, or length of postoperative stay. There was no evidence for a placebo effect of TENS on opioid use or pain scores. ClinicalTrials.gov: NCT04399707. Cardinal Health.

The Influence of Opioids on Transcutaneous Electrical Nerve Stimulation Effects in Women With Fibromyalgia

Transcutaneous electrical nerve stimulation (TENS) uses endogenous opioids to produce analgesia, and effectiveness can be reduced in opioid-tolerant individuals'. We examined TENS effectiveness (primary aim), and differences in fibromyalgia symptoms (secondary aim), in women with fibromyalgia regularly taking opioid (RTO) medications compared with women not- regularly taking opioids (not-RTO). Women (RTO n = 79; not-RTO not-n = 222) with fibromyalgia with daily pain levels ≥4 were enrolled and categorized into RTO (taking opioids at least 5 of 7 days in last 30 days) or not-RTO groups. Participants were categorized into tramadol n = 52 (65.8%) and other opioids n = 27 (34.2%) for the RTO group. Participants were phenotyped across multiple domains including demographics, fibromyalgia characteristics pain, fatigue, sleep, psychosocial factors, and activity. Participants were randomized to active TENS (n = 101), placebo TENS (n = 99), or no TENS (n = 99) for 1-month with randomization stratified by opioid use. Active TENS was equally effective in movement-evoked pain in those in the RTO and not-RTO groups. Women with fibromyalgia in the RTO group were older (P = .002), lower-income (P = .035), more likely to smoke (P = .014), and more likely to report depression (P = .013), hypertension (P = .005) or osteoarthritis (P = .027). The RTO group demonstrated greater bodily pain on SF-36 (P = .005), lower quality of life on the physical health component of the SF-36 (P = .040), and greater fatigue (MAF-ADL P = .047; fatigue with sit to stand test (P = .047) These differences were small of and unclear clinical significance. In summary, regular use of opioid analgesics does not interfere with the effectiveness of TENS for movement-evoked pain. Clinical Trial Registration Number: NCT01888640. PerspectiveIndividuals treated with mixed frequency TENS at a strong but comfortable intensity that was taking prescription opioid analgesics showed a significant reduction in movement-evoked pain and fatigue. These data support the use of TENS, using appropriate parameters of stimulation, as an intervention for individuals with fibromyalgia taking opioid analgesics.

Transcutaneous Electrical Nerve Stimulation in Management of Neurogenic bladder Secondary to Spina Bifida.

To assess the role of transcutaneous electrical nerve stimulation (TENS), alone or in combination with anticholinergic drugs in the management of neurogenic bladder (NB) in spina bifida (SB). All the consecutive patients, visiting outpatient clinic between July 2017 and December 2018, who were toilet trained and at least 1 year post-SB surgery with clinical and/or urodynamic evidence of NB, were included in the study. Out of 65 patients, 40 fulfilled the inclusion criteria and were randomised into: group A (ten patients, placebo TENS with anticholinergic agents), Group B (14 patients, TENS therapy with placebo medications) and Group C (16 patients, TENS therapy with anticholinergic medications). All the patients maintained a voiding diary and underwent assessment before and after the intervention. The study was approved by the Institutional Ethics Committee. The presenting symptoms were urinary incontinence (100%), increased frequency (45%), straining during micturition (22.5%), urgency (22.5%), and hesitancy (30%). The demographic parameters were comparable in all the groups. After group specific intervention, the wet episodes/day significantly improved in Group C (P = 0.001). Similarly, the mean wet days/week also improved significantly in Group C (6.5-4.37 days/week, P = 0.01). Out of 40 patients, 29 had abnormal findings on ultrasonography before the start of the therapy. Following intervention, only two patients in Group C showed normalization of findings. On Urodynamic studies, detrusor pressure (Pdet max) decreased in all the groups; however, the patients in Group C, showed the maximum reduction (56.6 ± 11-30 ± 6.7 cm H2O). Similarly compliance (9.4 to 14.5 cm H2O, P = 0.02) and bladder capacity (68%-88% of EBC, P = 0.001) also improved significantly in Group C as compared to other 2 groups Overall, nine patients (Group A, B, and C = 1, 3, and five patients, respectively) showed detrusor instability, while post therapy, only one patient (Group B) had unstable bladder. Maximum decrease in postvoid residue (mean) was also observed in Group C (77-41 ml, P = 0.01). The application of TENS in NB secondary to SB is effective and its application led to improvement in symptoms, decrease in the wet episodes/day, maximum detrusor pressure, instability, bladder compliance, and capacity. TENS therapy in combination with anticholinergic agents had a better outcome as compared to monotherapy with either of the two modalities.

Bilateral Transcutaneous Electrical Nerve Stimulation Improves Upper Limb Motor Recovery in Stroke: A Randomized Controlled Trial.

Recent evidence has shown bilateral transcutaneous electrical nerve stimulation (Bi-TENS) combined with task-oriented training (TOT) to be superior to unilateral transcutaneous electrical nerve stimulation (Uni-TENS)+TOT in improving lower limb motor functioning following stroke. However, no research explored the effect of Bi-TENS+TOT in improving upper limb motor recovery. This study aimed to compare Bi-TENS+TOT with Uni-TENS+TOT, Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)+TOT, and no treatment (Control) groups in upper limb motor recovery. This is a 4-group parallel design. One hundred and twenty subjects were given either Bi-TENS+TOT, Uni-TENS+TOT, Placebo-TENS+TOT, or Control without treatment in this randomized controlled trial. Twenty 60-minute sessions were administered 3× per week for 7 weeks. The outcome measure was the Fugl-Meyer Assessment of Upper Extremity, which was assessed at baseline, after 10 sessions (mid-intervention) and 20 sessions (post-intervention) of intervention, and at 1- and 3-month follow-up. Patients in the Bi-TENS+TOT group showed greater improvement in the Fugl-Meyer Assessment of Upper Extremity scores than Uni-TENS+TOT (mean difference, 2.13; P=0.004), Placebo-TENS+TOT (mean difference, 2.63; P<0.001), and Control groups (mean difference, 3.11; P<0.001) at post-intervention. Both Bi-TENS+TOT (mean difference, 3.39; P<0.001) and Uni-TENS+TOT (mean difference, 1.26; P=0.018) showed significant within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores. Patients in the Bi-TENS+TOT group showed earlier within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores at mid-intervention than Uni-TENS+TOT. These improvements were maintained at the 3-month follow-up assessment. Bi-TENS combined with TOT is an effective therapy for improving upper limb motor recovery following stroke. URL: https://www. gov; Unique identifier: NCT03112473.

Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial

To determine the effectiveness of TENS at relieving pain and improving physical function as compared to placebo TENS, and to determine its safety, in patients with knee osteoarthritis. Multi-centre, parallel, 1:1 randomized, double-blind, placebo-controlled clinical trial conducted in six outpatient clinics in Switzerland. We included 220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014. Patients were randomized to 3 weeks of treatment with TENS (n=108) or placebo TENS (n=112). Our pre-specified primary endpoint was knee pain at the end of 3-weeks treatment assessed with the WOMAC pain subscale. Secondary outcome measures included WOMAC physical function subscale and safety outcomes. There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference-0.06; 95%CI -0.41 to 0.29; P=0.74), nor throughout the trial duration (P=0.98). Subgroup analyses did not indicate an interaction between patient/treatment characteristics and treatment effect on WOMAC pain at the end of treatment (P-interaction ≥0.22). The occurrence of adverse events was similar across groups, with 10.4% and 10.6% of patients reporting events in the TENS and placebo TENS groups, respectively (P=0.95). No relevant differences were observed in secondary outcomes. TENS does not improve knee osteoarthritis pain when compared to placebo TENS. Therapists should consider other potentially more effective treatment modalities to decrease knee osteoarthritis pain and facilitate strengthening and aerobic exercise. Our findings are conclusive and further trials comparing TENS and placebo TENS in this patient population are not necessary.

Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 μs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study.

BackgroundThe purpose of this study was to assess the effectiveness of transcutaneous electrical nerve stimulation (TENS) in chronic low back pain and neuropathic pain.MethodsSeventy-four patients aged 18-65 with chronic low back pain were included in the study. Baseline measurements were performed, and patients were randomized into three groups. The first group received burst TENS (bTENS), the second group conventional TENS (cTENS), and the third group placebo TENS (pTENS), all over 15 sessions. Patients’ visual analogue scale (VAS) scores were evaluated before treatment (preT), immediately after treatment (postT), and in the third month after treatment (postT3). Douleur Neuropathique 4 Questions (DN4), the Modified Oswestry Low Back Pain Disability Questionnaire (MOS), the Beck Depression Inventory (BDI), and sympathetic skin response (SSR) values were also evaluated preT and postT3.ResultsA statistically significant improvement was observed in mean VAS scores postT compared to preT in all three groups. Intergroup comparison revealed a significant difference between preT and postT values, that difference being assessed in favor of bTENS at multiple comparison analysis. Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups. No statistically significant difference was also observed between the groups in terms of MOS, BDI, or SSR values at postT3 (P > 0.05).ConclusionsbTENS therapy in patients with low back pain is an effective and safe method that can be employed in short-term pain control.

Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial

ObjectiveTo compare the immediate analgesic effect of transcutaneous nerve stimulation (TENS) and interferential current (IFC), with different combinations of parameters, in individuals with chronic low back pain (CLBP). Methodology280 individuals with CLBP were included in the study, both genders, randomized in 8 groups: GI2KHz/100Hz, GI2KHz/2Hz, GI4KHz/100Hz, GI4KHz/2Hz, placebo interferential group (GIP), GT100Hz, GT2Hz, and placebo TENS group (GTP). All individuals underwent a single application of TENS or IFC for 30min. The assessments were carried out prior to the intervention, as well as immediately after, with the following outcomes: pain intensity (Numeric Pain Rating Scale-NPRS), qualitative pain characteristics (McGill Pain Questionnaire-MPQ), and pressure pain threshold (PPT) by pressure algometry (PA) in 4 points of the low back region. ResultsIn the intergroup comparison of NPRS, all intervention groups showed greater pain reduction compared to GTP (p < 0.05). In the total MPQ score, the groups that obtained significant results (p < 0.05) when compared to GTP were GT100Hz and GT2Hz, while the groups GT100Hz and GI4KHz/100Hz were significant when compared to GIP. In the PA, GI4KHz/100Hz showed an increase in the PPT in all points compared to GTP and GI2KHz/100Hz. ConclusionBoth TENS and IFC presented immediate analgesic effect in CLBP, with emphasis on the interferential current of 4 KHz modulated at 100Hz.

Hypoalgesic Effects of Transcutaneous Electrical Nerve Stimulation Combined With Joint Manipulation: A Randomized Clinical Trial

ObjectiveThe objective of this study was to compare the hypoalgesic effects of isolated or combined use of transcutaneous electrical nerve stimulation (TENS) and cervical joint manipulation (JM) in asymptomatic participants. MethodsOne hundred and forty-four healthy participants aged 18 to 30 years old were randomly assigned to 1 of 4 groups (n = 36 per group): active TENS + active JM, active TENS + placebo JM, placebo TENS + active JM, and placebo TENS + placebo JM. Active or placebo TENS was applied to the dominant forearm. JM was applied to the C6-7 segments. The pressure pain threshold was measured pre- and postintervention and after 20 minutes on the forearm and tibialis anterior of the dominant side. ResultsSegmental hypoalgesia was greater in the group active TENS + active JM compared with active TENS + placebo JM (P = .002), placebo TENS + active JM (P < .0001), and placebo TENS + placebo JM (P < .0001). For the extrasegmental hypoalgesia, active TENS + active JM had greater hypoalgesic effect compared with active TENS + placebo JM (P = .033), placebo TENS + active JM (P = .002), and placebo TENS + placebo JM (P < .0001). ConclusionTENS and JM produced hypoalgesia when used alone and, when the treatments were combined, a higher segmental and extrasegmental hypoalgesic effect was obtained in asymptomatic participants.

Evaluation of transcutaneous electrical nerve stimulation as an adjunct therapy in trigeminal neuralgia - a randomized double-blind placebo-controlled clinical study.

BackgroundTrigeminal neuralgia (TN) is a severe form of pain that affects the daily activities of a patient. Transcutaneous electrical nerve stimulation (TENS) therapy is an emerging option for the treatment of acute and chronic pain. The aim of this study was to evaluate the effect of TENS therapy as an adjunct to drug therapy for the treatment of TN.MethodsA total of 52 patients diagnosed with TN according to the International Classification of Headache Disorders (version 3) were included. Each patient was randomized to either the TENS or placebo TENS groups. Intervention was given in continuous mode and 100-Hz frequency for 20 mins biweekly for 6 weeks. Parameters were measured at baseline, TENS completion and 3 months, 6 months, and 1 year of follow up. The parameters observed were mean carbamazepine dose, mean visual analog scale (VAS) score, mean present pain intensity (PPI) score, and functional outcome. Non-parametric analyses, one-way ANOVA and the Kruskal-Wallis test were applied for intragroup comparisons, while the Mann-Whitney U test and independent t-test were used for intergroup comparisons of variables. The chi-square test was applied to analyze categorical data.ResultsCompared to the placebo TENS group, the mean dose of carbamazepine in the TENS group was significantly reduced at TENS completion, as well as at 6 months and 1 year follow up. Changes in mean VAS score, mean PPI score, and functional outcome did not show significant differences between the groups (P>0.05).ConclusionTENS therapy does not lead to any changes in pain levels but it may reduce the mean dose of carbamazepine when used as an adjunct treatment in patients with TN.

Challenges in recruitment and adherence to a randomized clinical trial in Brazil on the effects of transcutaneous nervous electrical stimulation on individuals with peripheral arterial disease: A feasibility study

Describe the feasibility, barriers during the recruitment and intervention period, recruitment rate (success and efficiency), and the level of participation and adherence in the randomized clinical trial to verify the effects of transcutaneous electrical nerve stimulation (TENS) for the symptoms of intermittent claudication (IC) and its repercussions on functional capacity, cardiorespiratory fitness and cardiovascular autonomic function in individuals with sta II Fontaine classification, residing in Brazil. Prospective, double-blind, randomized clinical trial. Level secondary. A total of 63 participants were screened, of which 12.6% were included. Eight individuals with peripheral arterial disease (PAD) and IC underwent a protocol that lasted 8weeks. The experimental group received 45minutes TENS 10Hz, followed by 30minutes of aerobic exercise, and the control group received a placebo TENS also followed by 30minutes of exercise. Incremental walking test, gait impairment questionnaire, treadmill test, heart rate variability, and 4-second test were applied, considering adherence, success, and efficiency. The most efficient recruitment sources were as follows: 1) referral by physician and 2) referral by a physiotherapist. Out of 63 participants, 8 (12.6%) were included in the clinical trial. Participants were excluded due to the following reasons: not meeting the criteria (41 participants (65%)), locomotion (6 participants (9.5%)), transportation (5 participants (7.9%)), work release (1 participant (1.6%)), and interest (2 participants (3.2%)). The overall participation was 99 participants (51.6%) in a total of 192 sessions offered. It was not possible to succeed in recruitment and adherence rates. The results of this clinical trial reinforce that PAD is neglected, and strategies including a multidisciplinary approach with the effective participation of nursing, physiotherapy, medicine, and nutrition professionals, are necessary to optimize care for individuals with PAD need to be strengthened. Brazilian Registry of Clinical Trials (RBR-8RTZFN).