Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Kong JT
PROVIDER: S-EPMC7592030 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial.
Kong Jiang-Ti JT Puetz Chelcie C Tian Lu L Haynes Isaac I Lee Eunyoung E Stafford Randall S RS Manber Rachel R Mackey Sean S
JAMA network open 20201001 10
<h4>Importance</h4>Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions.<h4>Objective</h4>To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors asso ...[more]
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Project description:BackgroundChronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA).MethodsWe present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8 weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0-100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4 weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d = 0.5) on temporal summation.DiscussionTo the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP.Trial registrationClinicalTrials.gov, NCT02503475 . Registered on 15 July 15 2015. Retrospectively registered.
| S-EPMC6292023 | biostudies-literature
Project description:BackgroundUse of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain.Methods/designThis study is a multi-center randomized sham-controlled trial with 2 parallel arms. Participants included in the study met the following criteria: 1) low back pain lasting for at least the last 3 months, 2) a documented >or= 5 points on a 10 cm visual analog scale for bothersomeness of low back pain at the time of screening and 3) between 18 and 65 years of age. Participants were blinded to the real and sham acupuncture treatments. The real acupuncture treatment group received real acupuncture 2 times a week, during a total of 12 sessions over 6 weeks. The control group received sham acupuncture during the same period. In order to assess the primary and secondary outcome measures, the participants were asked to fill out a questionnaire at the baseline and 6, 8, 12 and 24 weeks after starting the treatments. The primary outcome was measured using the visual analog scale for bothersomeness of low back pain at 8 weeks after the initiation of treatments.DiscussionThe result of this trial (which will be available in 2010) will demonstrate the efficacy of using acupuncture to treat chronic low back pain.Trial registrationThis study is registered with the U.S. National Institutes of Health Clinical Trials registry: NCT00815529.
| S-EPMC2896349 | biostudies-literature
Project description:BackgroundLow back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults.ObjectiveThe current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP.MethodsA five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects.DiscussionAlthough electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population.ConclusionThis is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population.Trial registrationClinicaltrials.gov, NCT03802045. Registered on 14 January 2019.
| S-EPMC6929454 | biostudies-literature
Project description:ObjectiveTo compare the effects of 4 months of isolated lumbar resistance exercise and total body resistance exercise on walking performance in obese, older adults with chronic low back pain. A secondary analysis examined whether responsiveness to training modulated walking improvement.DesignRandomized, controlled trial.SettingResearch laboratory affiliated with tertiary care facility.Methods and interventionParticipants (N = 49; 60-85 years) were randomized into a 4-month resistance exercise intervention (TOTRX), lumbar extensor exercise intervention (LEXT), or a control group (CON).Main outcome measurementsWalking performance, maximal low back strength and leg strength, and average resting and low back pain severity score (from an 11-point numerical pain rating scale; NRSpain) were collected at baseline and month 4.ResultsThe TOTRX and LEXT improved lumbar extensor strength relative to CON, and the TOTRX (P < .05). NRSpain scores at month 4 were lowest in the TOTRX group compared with the LEXT and CON groups, respectively (2.0 ± 1.7 points vs 3.7 ± 2.6 points and 4.6 ± 2.4 points; P < .006). A total of 53% and 67% of participants in the TOTRX and LEXT groups were responders who made lumbar extensor strength gains that achieved ≥20% greater than baseline values. Although the TOTRX demonstrated the greatest improvement in walking endurance among the intervention groups, this did not reach significance (10.1 ± 12.2% improvement in TOTRX vs 7.4 ± 30.0% LEXT and -1.7 ± 17.4% CON; P = .11). Gait speed increased most in the TOTRX (9.0 ± 13.5%) compared with the LEXT and CON groups (P < .05). The change in lumbar extensor strength explained 10.6% of the variance of the regression model for the change in walking endurance (P = .024).ConclusionsThe use of LEXT and TOTRX produced similar modest improvements in patients' walking endurance. Lumbar extensor strength gain compared with leg strength gain is a moderate but important contributor to walking endurance in obese older adults with chronic low back pain. Responders to resistance exercise programs (event those with only lumbar extension exercise) who make at least a 20% improvement in strength can expect better improvement in walking endurance than those who do not achieve this strength improvement.
| S-EPMC4013252 | biostudies-literature
Project description:Study designA population-based cross-sectional survey.ObjectiveThe aim of this study was to compare the prevalence of illicit drug use among US adults with and without chronic low back pain (cLBP).Summary of background dataAlthough addictive medications, such as opioids and benzodiazepines, are frequently prescribed to patients with cLBP, little is known about illicit drug use among Americans with cLBP.MethodsWe used data from the back pain survey, administered to a representative sample of US adults aged 20 to 69 years (N = 5103) during the 2009 to 2010 cycle of the National Health and Nutrition Examination Survey (NHANES). Participants with pain in the area between the lower posterior margin of the ribcage and the horizontal gluteal fold for at least 3 months were classified as having cLBP (N = 700). The drug use questionnaire was self-administered in a private setting, and included data on lifetime and current use of marijuana or hashish, cocaine, heroin, and methamphetamine. Chi-square tests, one-way analysis of variance, and logistic regression, adjusted for age, gender, race, and level of education, were used for comparisons.ResultsAbout 46.5% of US adults with cLBP used marijuana versus 42% of those without cLBP [Adjusted odds ratio (aOR) 1.36, 95% confidence interval (95% CI) 1.06-1.74]. About 22% versus 14% used cocaine (aOR 1.80, 95% CI 1.45-2.24), 9% versus 5% used methamphetamine (aOR 2.03, 95% CI 1.30-3.16), and 5% versus 2% used heroin (aOR 2.43, 95% CI 1.44-4.11). Subjects with cLBP who reported lifetime illicit drug use were more likely to have an active prescription for opioid analgesics than those without illicit drug use history: 22.5% versus 15.3%, P = 0.018.ConclusioncLBP in community-based US adults was associated with higher odds of using marijuana, cocaine, heroin, and methamphetamine. Prescription opioid analgesic use was more common in cLBP sufferers with a history of illicit drug use.Level of evidence2.
| S-EPMC5002230 | biostudies-literature
Project description:ImportanceOsteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations.ObjectiveTo compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP.Design, setting, and participantsThis prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018.InterventionsSix sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners.Main outcomes and measuresThe primary end point was mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.ResultsOverall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.Conclusions and relevanceIn this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.Trial registrationClinicalTrials.gov Identifier: NCT02034864.
| S-EPMC7961471 | biostudies-literature
Project description:ObjectivesThis study aimed to (1) compare postural sway patterns between individuals with chronic low back pain (CLBP) and asymptomatic controls, (2) evaluate correlations between pain severity and postural stability variables, and (3) assess the interaction effects of age, BMI, pain severity, and disability on postural stability under eyes-open and eyes-closed conditions.MethodsPostural stability (sway area, sway velocity, CoP displacement) was assessed in 88 CLBP patients and 88 controls using a stabilometric platform. Pain severity (VAS) and disability (ODI) were recorded alongside demographic data. Statistical analyses included t-tests, Pearson's correlations, and ANOVA to explore group differences, correlations, and interaction effects.ResultsChronic low back pain patients exhibited significantly greater postural sway across all conditions, with larger sway area (16.80 ± 6.10 cm2 vs. 11.50 ± 4.10 cm2, p = 0.004) and higher sway velocity (4.10 ± 1.40 cm/s vs. 2.90 ± 1.00 cm/s, p = 0.009) under eyes-closed conditions. Pain severity correlated with sway velocity (r = 0.52, p = 0.003) and CoP displacement (r = 0.57, p = 0.002). Interaction effects indicated greater instability in older, obese individuals with severe pain and high disability.ConclusionChronic low back pain is associated with impaired postural stability, influenced by pain severity, BMI, age, and disability. Targeted interventions addressing these factors are essential for improving balance and reducing fall risk.
| S-EPMC11782224 | biostudies-literature
Project description:AbstractChronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.
| S-EPMC8442741 | biostudies-literature
Project description:Bee venom acupuncture (BVA) is an effective treatment for chronic low back pain (CLBP) through the pharmacological effects of bee venom and the simultaneous stimulation of acupoints. However, evidence of its efficacy and safety in humans remains unclear. Using a double-blind, randomized study, 54 patients with non-specific CLBP were assigned to the BVA and sham groups. All participants underwent six sessions of real or sham BVA for 3 weeks, in addition to administration of 180 mg of loxonin per day. The primary outcome, that is, "bothersomeness" derived from back pain, was assessed using the visual analog scale. Secondary outcomes included pain intensity, dysfunction related to back pain (Oswestry Disability Index), quality of life (EuroQol 5-Dimension), and depressive mood (Beck's depression inventory). Outcomes were evaluated every week during the treatment period and followed up at weeks 4, 8, and 12. After 3 weeks of the treatment, significant improvements were observed in the bothersomeness, pain intensity, and functional status in the BVA group compared with the sham group. Although minimal adverse events were observed in both groups, subsequent recovery was achieved without treatment. Consequently, our results suggest that it can be used along with conventional pharmacological therapies for the treatment of CLBP.
| S-EPMC5705976 | biostudies-literature
Project description:IntroductionLow back pain (LBP) is the most prevalent form of chronic pain in active-duty military personnel worldwide. Electroacupuncture (EA) and neuromuscular electrical stimulation (NMES) are the two most widely used treatment methods in the military, while evidence for their benefits is lacking. The aim of this randomized clinical trial is to investigate the effectiveness of EA vs. NMES in reducing pain intensity among active-duty navy personals with chronic LBP.MethodsThe study is designed as a single-center, randomized controlled trial. The primary outcome is a positive categorical response for treatment success in the first-time follow-up, which is predesignated as a two-point or greater decrease in the NRS score and combined with a score > 3 on the treatment satisfaction scale. The secondary outcomes include pain intensity, rate of treatment success, and Oswestry Disability Index (ODI) fear-avoidance beliefs questionnaire (FABQ) score along with muscular performance. The first follow-up starts on the first day after completing the last treatment session, and then the 4-weeks and 12-weeks follow-up are applied via telephone visit.ResultsEighty-five subjects complete the treatment diagram and are included in the analysis. For the primary outcome, no difference has been found between EA and NMES, with 65.1% (28 in 43) individuals reporting a positive response to EA treatment, while 53.5% (23 in 43) in NMES. However, for longer follow-ups, superiority in positive response of EA has been found in 4-weeks (26 in 39, 66.7% vs. 16 in 40, 40%; P = 0.018) and 12-weeks (24 in 36, 66.7% vs. 12 in 36, 33.3%; P = 0.005) follow-up. In the regression analysis, baseline pain intensity and FABQ score are identified to be highly associated with positive treatment outcomes. Finally, the subgroup analysis suggests that EA treatment is associated with better long-term outcomes in patients with LBP with a severe pain score (NRS score >4, Figure 4B) and stronger fear-avoidance beliefs.ConclusionBoth the EA and NMES are associated with a positive response in treating military LBP, and the former offers lasting benefits in the later follow-ups. Thus, electroacupuncture is a more recommended treatment for military LBP. A lot of research is needed to verify an efficient and standardized treatment session, with more information and evidence about indications for these treatments.Trial registrationChiCTR, (ChiCTR2100043726); registered February 27, 2021.
| S-EPMC9513143 | biostudies-literature