A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial.
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ABSTRACT: Introduction
Low back pain (LBP) poses a significant burden of disease worldwide, and identifying safe and effective non-pharmacologic treatment options for LBP is a research priority. The aim of this study was to pilot a clinical trial of a portable pulsed electromagnetic field (PEMF) therapy device for subjects with mixed duration non-specific LBP.Methods
This work was a randomized, double-blind, sham-controlled, parallel-group study conducted at a chiropractic school outpatient clinic. The primary end point was functional capacity measured by the Oswestry Disability Index (ODI) at baseline, 6 weeks, and 12 weeks. Analysis was conducted on the intent-to-treat population and as a trend of change in pain scores over time using the Freidman test of repeated measures.Results
Forty-two participants were randomized to receive usual care plus PEMF therapy or usual care plus sham, and 25 completed the study. Significant improvements in ODI scores from baseline to week 6 were reported in the experimental group (χ2 = 14.68, p < 0.001, compared with patients in the sham group, χ2 = 4.00, p = 0.135, n.s.). This difference persisted at week-12 follow-up. Adverse events were rare and mild.Conclusion
It is feasible to conduct a clinical trial of a PEMF therapy device for non-specific LBP. This work shows that the device was safe and provides preliminary evidence of effectiveness in improving function in patients with non-specific LBP.Trial registration
ClinicalTrials.gov identifier, NCT03053375.Funding
Aerotel Ltd.
SUBMITTER: Lisi AJ
PROVIDER: S-EPMC6513933 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe incidence of chronic postoperative pain following lumbar spinal surgery has increased with the overall increase in the prevalence of lumbar surgery. This study was conducted to evaluate the analgesic effectiveness of pulsed electromagnetic field (PEMF) therapy in subjects with persistent pain following lumbar surgery.Patients and methodsA randomized, double-blind, sham-controlled, multicenter study in 36 subjects with persistent low-back and/or radiating leg pain after lumbar surgery was conducted. Eligible subjects were randomized (1:1:1) to receive one of two doses of therapy (42-μs or 38-μs pulse width) or treatment with a sham device. Subjects self-treated twice daily for 60 days. The primary end point was change in pain intensity (∆PI) using the Numerical Pain Rating Scale between average baseline (Days -5 to -1) and end of treatment (Days 56-60) for lumbar and radiating leg pain. Secondary outcome measures included the Oswestry Disability Index, Beck Depression Inventory-II, Patient Global Impression of Change, and consumption of analgesics.ResultsLow-back pain scores for the 42-μs group decreased by 40.2% (p = 0.028), compared to 18.6% for the 38-μs pulse width group (p = 0.037) and 25.6% for the sham group (p = 0.013 per protocol population). Average leg pain scores decreased by 45.0% (42 μs, p = 0.009), 17.0% (38 μs, p = 0.293), and 24.5% (sham, p = 0.065). The proportion of subjects responding to therapy, time to 30% reduction in pain scores, and Patient Global Impression of Change were improved with the PEMF 42-μs device over the sham control, although results were associated with p-values >0.05.ConclusionPEMF therapy (42-μs pulse width) was associated with trends for a reduction in pain, compared to sham treatment. Secondary endpoints were consistent with an overall beneficial effect of the PEMF 42-μs pulse width device.
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Project description:BackgroundLow back pain that lasts longer than three months is called chronic low back pain. Chronic low back pain is among the most common problems in the world, causing severe disability and loss of employment in patients.ObjectiveTo investigate the effect of pulse electromagnetic field therapy (PEMFT) added to routine physical therapy on pain and functional status in patients with chronic low back pain.MethodsThis retrospective comparative study included 69 patients with chronic low back pain. The patients were divided into two groups: those who received lumbar transcutaneous electrical nerve stimulation, infrared, and ultrasound treatments, and those who additionally received PEMFT. The files of patients with chronic low back pain were reviewed, and those who had been evaluated using the Quebec Back Pain Disability Scale (QBPDS) in terms of functional capacity and effects of low back pain and the Visual Analogue Scale (VAS) for pain both before and after treatment were included in the study.ResultsNo significant difference was detected between the two groups' pretreatment VAS and QBPDS scores (p > 0.05). The second-and-third measurement scores of both groups were significantly lower than their first-measurement VAS and QBPDS scores (p ˂ 0.001), but there was no significant difference between their second- and third-measurement scores (p > 0.05). According to the inter-group comparison of the VAS and QBPDS scores, the second and third-measurement scores of the PEMFT group were significantly lower than those of the control group (p ˂ 0.001).ConclusionsPEMFT seems to be able to alleviate pain intensity and ameliorate disability in patients with chronic low back pain. PEMFT can be considered an effective and safe option that can be added to routine physical therapy modalities for relieving chronic low back pain frequently encountered in clinical practice. Further studies validating the effectiveness of PEMFT could strengthen its position in the management of chronic low back pain.
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Project description:IntroductionThe aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).Methods and analysisA randomised double-blinded controlled clinical trial will be conducted, involving 200 patients with CLBP. Participants will be randomised in a 1:1 ratio to receive either active PLFMF (experimental arm) or sham treatment (control arm) using a permuted-block design which will be stratified according to three subtypes of musculoskeletal CLBP (nociceptive, peripheral neuropathic or central sanitisation). The intervention consists of three sessions/week for 6?weeks. The primary outcome is the percentage change in Numerical Rating Scale (NRS) pain at week 24 after treatment completion with respect to the baseline. Secondary outcomes include percentage NRS pain during treatment and early after treatment completion, short form 36 quality of life, Roland and Morris Disability Questionnaire; Depression Anxiety Stress Scale 21, Patient Specific Functional Scale, Global perceived effect of condition change, Pittsburgh Sleep Quality Index and Modified Fatigue Impact Scale. Measures will be taken at baseline, 3 and 6?weeks during the intervention and 6, 12 and 24?weeks after completing the intervention. Adverse events between arms will be evaluated. Data will be analysed on an intention-to-treat basis.Ethics and disseminationThe study is funded by Imam Abdulrahman Bin Faisal University (IAU). It has been approved by the institutional review board of IAU (IRB- 2017-03-129). The study will be conducted at King Fahd Hospital of the University and will be monitored by the Hospital monitoring office for research and research ethics. The trial is scheduled to begin in September 2018. Results obtained will be presented in international conferences and will be published in peer-reviewed journals.Trial registration numberACTRN12618000921280, prospectively.
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Project description:BACKGROUND:For many years, low back pain has been both the leading cause of days lost from work and the leading indication for medical rehabilitation. The goal of the German Disease Management Guideline (NDMG) on nonspecific low back pain is to improve the treatment of patients with this condition. METHODS:The current update of the NDMG on non-specific low back pain is based on articles retrieved by a systematic search of the literature for systematic reviews. Its recommendations for diagnosis and treatment were developed by a collaborative effort of 29 scientific medical societies and organizations and approved in a formal consensus process. RESULTS:If the history and physical examination do not arouse any suspicion of a dangerous underlying cause, no further diagnostic evaluation is indicated for the time being. Passive, reactive measures should be taken only in combination with activating measures, or not at all. When drugs are used for symptomatic treatment, patients should be treated with the most suitable drug in the lowest possible dose and for as short a time as possible. CONCLUSION:A physician should be in charge of the overall care process. The patient should be kept well informed over the entire course of his or her illness and should be encouraged to adopt a healthful lifestyle, including regular physical exercise.
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Project description:BackgroundThe value of pulsed electromagnetic field (PEMF) in postoperative pain management, due to the inconsistent findings so far, remains unclear. We extended the evaluation of PEMF on postoperative pain and intravenous (IV) analgesic use to a group of post-appendicectomy Asian patients.MethodsThis is a double-blinded, randomized trial. Adults with a clinical diagnosis of acute appendicitis were enrolled. Patients were allocated randomly to receive an active-PEMF device or an inactive device after the surgery in addition to the standard postoperative pain management. The primary outcome measure was the 12-h cumulative postoperative pain intensity measured at four different time points using the visual analogue scale. The secondary outcome measure was the total amount of IV fentanyl used (in mg) via PCA over the first 12 postoperative hours. The primary analysis in this trial compared the two study groups for the reported cumulative pain score (both at rest and on movement) and the cumulative amount of IV fentanyl uses over the first 12 postoperative hours using the Wilcoxon rank sum test. Analyses were performed based on the intention-to-treat principal. Multiple imputation was used to handle the missing data assuming that the data were missing at random.FindingsOne hundred eighteen subjects were randomized; 58 were allocated to the active-PEMF group and 60 to the inactive control group. Pooled mean pain score of both intervention groups by time point declined in a similar fashion over the course of 12 postoperative hours. The 12-h cumulative postoperative pain score at rest and on movement did not differ significantly after the procedure. (W = 1832.5 ~ 1933.0, p-value 0.6192 ~ 0.2985 for resting pain score comparison; W = 1737.0 ~ 1804.5, p-value 0.9892 ~ 0.7296 for movement pain score comparison). For the secondary outcome measure of 12-h total fentanyl use, a comparison between the PEMF vs. placebo arm also revealed no statistically significant difference across all the 20 imputed datasets (W = 1676.5 ~ 1859.0, p-value 0.7344 ~ 0.5234).DiscussionPEMF was not superior to placebo as an adjunct pain management for up to 12 h post-appendicectomy. Previously reported effect of PEMF on postoperative pain intensity and analgesia uses in similar surgical settings cannot be verified.Trial registrationNational Medical Research Register Malaysia (NMRR-15-670-25,805) and Thai Clinical Trials Registry (retrospectively registered on November 01, 2019, Study ID-TCTR20191102002).
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Project description:Non-specific low back pain is defined as pain located in the lumbar region; this condition is the most frequent musculoskeletal disorder. Negative pulsed-pressure myofascial vacuum therapy (vacuum treatment (VT)) devices mobilize tissue according to previously programmed parameters of force, time and frequency. The purpose of this study was to compare the effects of VT combined with core therapeutic exercise versus a physical therapy program (PTP) based only on core therapeutic exercise. Fifty participants with chronic non-specific low back pain were randomly assigned to two treatment groups, the VT group (n = 25) or the PTP group (n = 25). Pain, pressure-pain threshold, range of motion, functionality and quality of life were measured before treatment, at the end of treatment, and at one-month and three-month follow-ups. Both groups received 15 therapy sessions over 5 weeks. Statistically significant differences in favor of the VT group were shown in the results. In conclusion, the intervention based on myofascial vacuum therapy improved pain, mobility, pressure pain threshold, functionality and quality of life.
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Project description:BackgroundAntidepressants are commonly used in the management of low-back pain. However, their use is controversial.ObjectivesThe aim of this review was to determine whether antidepressants are more effective than placebo for the treatment of non-specific low-back pain.Search strategyRandomised controlled trials were identified from MEDLINE and EMBASE (to September 2007), PsycINFO to June 2006, the Cochrane Central Register of Controlled Trials 2006, issue 2, and previous systematic reviews.Selection criteriaWe included randomised controlled trials that compared antidepressant medication and placebo for patients with non-specific low-back pain, and used at least one clinically relevant outcome measure.Data collection and analysisTwo blinded review authors independently extracted data and assessed the methodological quality of the trials. Meta-analyses were used to examine the effect of antidepressants on pain, depression and function, and the effect of antidepressant type on pain. To account for studies that could not be pooled, additional qualitative analyses were performed using the levels of evidence recommended by the Cochrane Back Review Group.Main resultsTen trials that compared antidepressants with placebo were included in this review. The pooled analyses showed no difference in pain relief (six trials; standardized mean difference (SMD) -0.06 (95% confidence interval (CI) -0.28 to 0.16)) or depression (two trials; SMD 0.06 (95% CI -0.29 to 0.40)) between antidepressant and placebo treatments. The qualitative analyses found conflicting evidence on the effect of antidepressants on pain intensity in chronic low-back pain, and no clear evidence that antidepressants reduce depression in chronic low-back pain patients. Two pooled analyses showed no difference in pain relief between different types of antidepressants and placebo. Our findings were not altered by the sensitivity analyses which varied the level of methodological quality required for inclusion in the meta-analyses to allow data from additional trials to be examined. Two additional trials were identified in September 2007 and await assessment.Authors' conclusionsThere is no clear evidence that antidepressants are more effective than placebo in the management of patients with chronic low-back pain. These findings do not imply that severely depressed patients with back pain should not be treated with antidepressants; furthermore, there is evidence for their use in other forms of chronic pain.
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Project description:The classification of non-specific chronic low back pain (CLBP) according to multidimensional data could guide clinical management; yet recent systematic reviews show this has not been attempted. This was a prospective cross-sectional study of participants with CLBP (n = 21) and age-, sex- and height-matched pain-free controls (n = 21). Nervous system, lumbar spinal tissue and psychosocial factors were collected. Dimensionality reduction was followed by fuzzy c-means clustering to determine sub-groups. Machine learning models (Support Vector Machine, k-Nearest Neighbour, Naïve Bayes and Random Forest) were used to determine the accuracy of classification to sub-groups. The primary analysis showed that four factors (cognitive function, depressive symptoms, general self-efficacy and anxiety symptoms) and two clusters (normal versus impaired psychosocial profiles) optimally classified participants. The error rates in classification models ranged from 4.2 to 14.2% when only CLBP patients were considered and increased to 24.2 to 37.5% when pain-free controls were added. This data-driven pilot study classified participants with CLBP into sub-groups, primarily based on psychosocial factors. This contributes to the literature as it was the first study to evaluate data-driven machine learning CLBP classification based on nervous system, lumbar spinal tissue and psychosocial factors. Future studies with larger sample sizes should validate these findings.
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Project description:BackgroundChronic pain can disrupt the cortical representation of a painful body part. This disruption may play a role in maintaining the individual's pain. Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions. However, there is little evidence for the effectiveness of this intervention for chronic low back pain (CLBP). The primary aim of this study was to inform the development of a fully powered randomised controlled trial (RCT) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP. The secondary aim was to obtain qualitative feedback about the intervention.MethodsIn this mixed-methods pilot RCT 15 individuals were randomised to either an intervention (tactile acuity training) or a placebo group (sham tactile acuity training). All participants received 3 sessions of acuity training (intervention or sham) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer (friend/relative). All participants also received usual care physiotherapy. The primary outcome measures were pain (0-100visual analogue scale (VAS)) and function (Roland Morris Disability Questionnaire (RMDQ)). Participants and their informal carers were invited to a focus group to provide feedback on the intervention.ResultsThe placebo group improved by the greatest magnitude for both outcome measures, but there was no statistically significant difference (Mean difference (95%CI), p-value) between groups for change in pain (25.6 (-0.7 to 51.9), p = 0.056) or function (2.2 (-1.6 to 6.0), p = 0.237). Comparing the number of individuals achieving a minimally clinically significant improvement, the placebo group had better outcomes for pain with all participants achieving ?30% improvement compared to only a third of the intervention group (6/6 vs. 3/9, p = 0.036). Qualitatively, participants reported that needing an informal carer was a considerable barrier to the home training component of the study.ConclusionsThis pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP. That the intervention could not be self-applied was a considerable barrier to its use.Trial registration isrctnISRCTN98118082.
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