Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.
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SUBMITTER: Johnson MI
PROVIDER: S-EPMC6485914 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPain reduction can be achieved by lowering proinflammatory cytokine levels in the blood. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive physiotherapeutic resource for pain management, but evidence on the effectiveness of this device at reducing proinflammatory cytokines in the blood is unclear. This study systematically reviews the literature on the effect of TENS on proinflammatory cytokines.MethodsA systematic review protocol was developed based on searches of articles in six electronic databases and references of retrieved articles, contact with authors, and repositories of clinical trials. Eligibility criteria: publication in peer-reviewed journals, randomized clinical trials, use of TENS in the experimental group, and pre- and post-measurements of proinflammatory cytokines in the blood. Selection of the studies and extraction of the data will be carried out by two reviewers independently. Characteristics of the study, participants, interventions and outcomes were extracted and described. Assessments were performed on the risk of bias, level of evidence and the size of the intervention effect in the studies, according to GRADE guidelines and the Cochrane Handbook for Systematic Reviews. Clinical and statistical assessments compared the effects of the interventions (meta-analysis), taking into consideration any influencing characteristics of the studies (e.g., methods and application sites).DiscussionWe anticipate that this review will strengthen evidence-based knowledge of the effect of TENS on proinflammatory cytokines and, as a result, direct new studies to benefit patients with specific pathologies.Systematic review registrationPROSPERO, CRD42017060379 .
| S-EPMC5505047 | biostudies-literature
Project description: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.Clinicaltrialsgov registrationNCT03714425.
| S-EPMC8318714 | biostudies-literature
Project description:AbstractWe previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.
| S-EPMC8049882 | biostudies-literature
Project description:The oral functions of patients are markedly diminished immediately after orthognathic surgery, and novel approaches are needed to accelerate their recovery. The aim of this study was to examine the usefulness of weekly applications of transcutaneous electrical nerve stimulation (TENS) for this purpose, based on the evidence of its effectiveness in other types of patients with muscle alterations. Maximum jaw opening, bite force, pain, and facial inflammation were compared between patients receiving TENS and those receiving sham-TENS for 30 min at baseline and weekly over a four-week period after orthognathic surgery and were also compared between the before and after of each procedure. TENS was applied at 220 Hz, applying the maximum intensity tolerated by each individual patient. The TENS procedure was identical for all patients, but the device was not turned on in the sham-TENS group. Patients were blinded to their group membership. Results were analyzed separately in skeletal class II and III patients. Improvements in jaw opening and inflammation were significantly greater in the TENS than in the sham-TENS group, attributable to the muscle relaxation achieved with the procedure. Research is warranted on the benefits of a more frequent application of TENS.
| S-EPMC9225233 | biostudies-literature
Project description:Introduction:Given the high rates of opioid addiction and overdose in the United States, non-opioid means of treating pain are increasingly needed. Transcutaneous electrical nerve stimulation (TENS) therapy is an effective non-opioid modality for treating pain, but has not yet been routinely used in emergency department (ED) settings. In this study we asked the following questions: Are TENS units a feasible treatment for pain in the ED? How effective are TENS units for the management of pain in a general ED population? Methods:At our institution, we performed a pilot study using TENS units for pain. Patients in the ED were given, at the discretion of the ED provider, TENS units for the treatment of pain. Patients could be included for acute or chronic pain on whatever part of the body that was safe to use with TENS. Results:A chart review of patients receiving TENS units in the ED (n=110) revealed that TENS was useful in relieving pain, along with other treatments, in 99% of cases. When surveyed, 83% of patients reported a functional improvement while using the TENS, and 100% of patients would recommend a TENS unit to a family or friend. When surveyed, 100% of ED staff observed that TENS units were effective in treating pain for patients, and 97% would want to use them if they themselves were patients. Conclusion:Overall, in this small pilot study, TENS units appeared to be effective in our ED for reducing pain, when added to standard treatment. Additional studies are needed to determine which conditions are most responsive to TENS therapy, and the magnitude of pain reduction when used alone.
| S-EPMC6123101 | biostudies-literature
Project description:IntroductionTranscutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention clinically used for pain relief. The importance of utilizing the adequate stimulation intensity is well documented; however, clinical methods to achieve the highest possible intensity are not established.ObjectivesOur primary aim was to determine if exposure to the full range of clinical levels of stimulation, from sensory threshold to noxious, would result in higher final stimulation intensities. A secondary aim explored the association of pain, disease severity, and psychological variables with the ability to achieve higher final stimulation intensity.MethodsWomen with fibromyalgia (N=143) were recruited for a dual-site randomized controlled trial - Fibromyalgia Activity Study with TENS (FAST). TENS electrodes and stimulation were applied to the lumbar area, and intensity was increased to sensory threshold (ST), then to "strong but comfortable" (SC1), then to "noxious" (N). This was followed by a reduction to the final stimulation intensity of "strong but comfortable" (SC2). We called this the Setting of Intensity of TENS (SIT) test.ResultsThere was a significant increase from SC1 (37.5 mA IQR: 35.6-39.0) to SC2 (39.2 mA IQR: 37.1-45.3) (p<0.0001) with a mean increase of 1.7 mA (95% CI: 1.5, 2.2). Linear regression analysis showed that those with the largest increase between SC1 and N had the largest increase in SC2-SC1. Further, those with older age and higher anxiety were able to achieve greater increases in intensity (SC2-SC1) using the SIT test.ConclusionThe SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety. Thus, although all patients may benefit from this protocol, older women and women with elevated anxiety receive the greatest benefit.
| S-EPMC6188186 | biostudies-literature
Project description:Resistant hypertension (RH) treatment requires an adequate and intense therapeutic approach. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of RH, sympathetic overstimulation and therapies that block the sympathetic system have been widely studied. These approaches, however, are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a noninvasive method that modulates activity by using low-frequency transcutaneous electrical stimulation to inhibit primary afferent pathways. Thus, the current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with RH and will seek to develop a new low-cost and readily available therapy to treat this group of hypertensive individuals.This is a randomized, single blind (subject), parallel-assignment study controlled with a sham group and including participants aged 40 to 70 years with resistant hypertension. The trial has two arms: the treatment and control (sham group). The treatment group will be submitted to the stimulation procedure (TENS). The sham group will not be submitted to stimulation. The primary outcomes will be a reduction in the peripheral blood pressure and adverse events. The secondary outcomes will be a reduction the central blood pressure. The study will last 30 days. The sample size was calculated assuming an alpha error of 5 % to reject the null hypothesis with a statistical power of 80 %, thereby resulting in 28 participants per group (intervention versus sham).In recent decades, RH has become very common and costly. Adequate control requires several drugs, and in many cases, treatment is not successful. Sympathetic nervous system inhibition by renal denervation and central inhibition have significant effects in reducing BP; however, these treatments are costly and invasive. Another type of sympathetic nervous system inhibition can also be noninvasively achieved by electric current. Therefore, the application of TENS may be a new therapeutic option for treating resistant hypertensive individuals.Clinical Trials NCT02365974.
| S-EPMC4812656 | biostudies-literature
Project description:BackgroundFibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.ObjectivesThe purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.DesignThis will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.ParticipantsThree hundred forty-three participants with fibromyalgia will be recruited for this study.InterventionParticipants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.MeasurementsThe primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.LimitationsBecause having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.ConclusionsThe results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.
| S-EPMC4295083 | biostudies-literature
Project description:The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is no consensus regarding the effectiveness dose of TENS. The objective was to determine the difference in the effect of spinal TENS on soleus H-reflex modulation when applied by two therapists instructed to apply the stimulation at a "strong but comfortable" intensity. Twenty healthy volunteers divided into two groups: Therapist 1 (n = 10) and Therapist 2 (n = 10). Both therapist applied spinal TENS and sham stimulation at the T10-12 spinal level for 40min in random order to each subject, at an intensity designed to produce a "strong but comfortable" sensation. To avoid habituation, the intensity was adjusted every 2min. Soleus H-reflex was recorded before, during, and 10min after TENS by an observer blinded to the stimulus applied. Despite the instruction to apply TENS at a "strong comfortable" level, a significant difference in current density was identified: Therapist 1 (0.67mA/cm2, SD 0.54) applied more than Therapist 2 (0.53mA/cm2, SD 0.57; p<0.001) at the onset of the intervention. Maximal peak-to-peak H-reflex amplitude was inhibited significantly more 10min following TENS applied by Therapist 1 (-0.15mV, SD 0.16) compared with Therapist 2 (0.04mV, SD 0.16; p = 0.03). Furthermore, current density significantly correlated with the inhibitory effect on peak-to-peak Soleus H-reflex amplitude 10 min after stimulation (Rho = -0.38; p = 0.04). TENS intensity dosage by the therapist based on the subjective perception of the participants alone is unreliable and requires objective standardization. In addition, higher current density TENS produced greater inhibition of the Soleus H-reflex.
| S-EPMC5731687 | biostudies-literature
Project description:IntroductionThe aim of this systematic review with meta-analysis is to evaluate the clinical efficacy of transcutaneous electrical nerve stimulation (TENS) for any type of acute and chronic pain in adults.Methods and analysisWe intend to search electronic databases (Cochrane Library, MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDRO, Web of Science, AMED and SPORTDiscus) from inception to the present day to identify all randomised controlled trials (RCT) on the use of TENS in adults for any type of pain including acute pain, chronic pain and cancer-related pain. We will screen the RCTs against eligibility criteria for inclusion in our review. Two reviewers will independently undertake RCT selection, data extraction and risk of bias assessment. Primary outcomes will be: (i) participant-reported pain relief of ≥30% expressed as frequency (dichotomous) data; and (ii) participant-reported pain intensity expressed as mean (continuous) data. We will conduct meta-analyses to determine risk ratio for dichotomous data, and mean difference (MD) or standardised MD for continuous data for TENS versus placebo TENS, no treatment or waiting list control, standard of care, and other treatments. Subgroup analyses will include different pain conditions (eg, acute vs chronic), TENS intensity, during versus after TENS, TENS as a sole treatment versus TENS in combination with other treatments and TENS administered as a single dose versus repetitive dose.Ethics and disseminationThis systematic review will not use data from individual participants, and the results will be disseminated in a peer-reviewed publication and presented at a conference.Prospero registration numberCRD42019125054.
| S-EPMC6830670 | biostudies-literature