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Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review
Luke Perraton, Zuzana Machotka, Saravana Kumar
Journal of Pain Research , 2009, DOI: http://dx.doi.org/10.2147/JPR.S8052
Abstract: mponents of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review Review (6982) Total Article Views Authors: Luke Perraton, Zuzana Machotka, Saravana Kumar Published Date November 2009 Volume 2009:2 Pages 165 - 173 DOI: http://dx.doi.org/10.2147/JPR.S8052 Luke Perraton, Zuzana Machotka, Saravana Kumar International Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, Australia Aim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.
Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review  [cached]
Luke Perraton,Zuzana Machotka,Saravana Kumar
Journal of Pain Research , 2009,
Abstract: Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed.Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery.Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.Keywords: hydrotherapy, fibromyalgia syndrome, exercise, effective, components
Efficacy and Effectiveness of Exercise on Tender Points in Adults with Fibromyalgia: A Meta-Analysis of Randomized Controlled Trials  [PDF]
George A. Kelley,Kristi S. Kelley,Dina L. Jones
Arthritis , 2011, DOI: 10.1155/2011/125485
Abstract: Fibromyalgia is a major public health problem affecting an estimated 200 to 400 million people worldwide. The purpose of this study was to use the meta-analytic approach to determine the efficacy and effectiveness of randomized controlled exercise intervention trials (aerobic, strength training, or both) on tender points (TPs) in adults with fibromyalgia. Using random effects models and 95% confidence intervals (CI), a statistically significant reduction in TPs was observed based on per-protocol analyses (8 studies representing 322 participants) but not intention-to-treat analyses (5 studies representing 338 participants) (per-protocol, , −0.68, 95% CI, −1.16, −0.20; intention-to-treat, , −0.24, 95% CI, −0.62, 0.15). Changes were equivalent to relative reductions of 10.9% and 6.9%, respectively, for per-protocol and intention-to-treat analyses. It was concluded that exercise is efficacious for reducing TPs in women with FM. However, a need exists for additional well-designed and reported studies on this topic.
Efficacy and Effectiveness of Exercise on Tender Points in Adults with Fibromyalgia: A Meta-Analysis of Randomized Controlled Trials  [PDF]
George A. Kelley,Kristi S. Kelley,Dina L. Jones
Arthritis , 2011, DOI: 10.1155/2011/125485
Abstract: Fibromyalgia is a major public health problem affecting an estimated 200 to 400 million people worldwide. The purpose of this study was to use the meta-analytic approach to determine the efficacy and effectiveness of randomized controlled exercise intervention trials (aerobic, strength training, or both) on tender points (TPs) in adults with fibromyalgia. Using random effects models and 95% confidence intervals (CI), a statistically significant reduction in TPs was observed based on per-protocol analyses (8 studies representing 322 participants) but not intention-to-treat analyses (5 studies representing 338 participants) (per-protocol, , ?0.68, 95% CI, ?1.16, ?0.20; intention-to-treat, , ?0.24, 95% CI, ?0.62, 0.15). Changes were equivalent to relative reductions of 10.9% and 6.9%, respectively, for per-protocol and intention-to-treat analyses. It was concluded that exercise is efficacious for reducing TPs in women with FM. However, a need exists for additional well-designed and reported studies on this topic. 1. Introduction Fibromyalgia (FM), a chronic disorder characterized by widespread musculoskeletal pain, fatigue, and tenderness in localized areas, is a syndrome of unknown etiology. An estimated 200 to 400 million adults worldwide have FM with prevalence rates higher among women than men [1]. In addition to the personal consequences, substantial healthcare costs are accrued. For example, between 2002 and 2005, annual healthcare costs in the US were three times higher in people with FM versus those without FM [2]. Management of FM includes both pharmacologic and nonpharmacologic approaches [3]. One nonpharmacologic approach is exercise, a low-cost intervention that is available to the vast majority of people with FM. A previous meta-analysis that included six studies published up to July of 2005, and in which one of the outcomes for widespread pain and tenderness was tender-points (TP) assessment, concluded that moderate-intensity aerobic exercise training probably leads to little or no difference in TP scores while strength training may result in large reductions in TP scores [4]. However, since that time, additional studies leading to conflicting results on this topic have been published and/or located [5–8]. In addition, while the authors preferentially analyzed intention-to-treat results, they also mixed these analyses with per-protocol results if data for the former were not available. This may be problematic, since each approach attempts to answer a different research question [9]. Furthermore, meta-analyses need to be updated on a regular
Massage Therapy for Fibromyalgia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials  [PDF]
Yan-hui Li, Feng-yun Wang, Chun-qing Feng, Xia-feng Yang, Yi-hua Sun
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0089304
Abstract: Background Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. Objective The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Methods Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I2 statistic. Results Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI ?0.38 to 0.75; p = 0.52). Conclusion Massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.
Three-Armed Trials Including Placebo and No-Treatment Groups May Be Subject to Publication Bias: Systematic Review  [PDF]
Yun Hyung Koog, Seo Ryang We, Byung-Il Min
PLOS ONE , 2011, DOI: 10.1371/journal.pone.0020679
Abstract: Background It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with active treatment, placebo, and no-treatment groups. Methods Three-armed randomized trials of acupuncture, acupoint stimulation, and transcutaneous electrical stimulation were obtained from electronic databases. Effect sizes between treatment and placebo groups were calculated for treatment effect, and effect sizes between placebo and no-treatment groups were calculated for placebo effect. All data were then analyzed for publication bias. Results For the treatment effect, small trials with fewer than 100 patients per arm showed more benefits than large trials with at least 100 patients per arm in acupuncture and acupoint stimulation. For the placebo effect, no differences were found between large and small trials. Further analyses showed that the treatment effect in acupuncture and acupoint stimulation may be subject to publication bias because study design and any known factors of heterogeneity were not associated with the small study effects. In the simulation, the magnitude of the placebo effect was smaller than that calculated after considering publication bias. Conclusions Randomized three-armed trials, which are necessary for estimating the placebo effect, may be subject to publication bias. If the magnitude of the placebo effect is assessed in an intervention, the potential for publication bias should be investigated using data related to the treatment effect.
Moxibustion and other acupuncture point stimulation methods to treat breech presentation: a systematic review of clinical trials
Xun Li, Jun Hu, Xiaoyi Wang, Huirui Zhang, Jianping Liu
Chinese Medicine , 2009, DOI: 10.1186/1749-8546-4-4
Abstract: We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on moxibustion, acupuncture or any other acupoint stimulating methods for breech presentation in pregnant women. All searches in PubMed, the Cochrane Library (2008 Issue 2), China National Knowledge Information (CNKI), Chinese Scientific Journal Database (VIP) and WanFang Database ended in July 2008. Two authors extracted and analyzed the data independently.Ten RCTs involving 2090 participants and seven CCTs involving 1409 participants were included in the present study. Meta-analysis showed significant differences between moxibustion and no treatment (RR 1.35, 95% CI 1.20 to 1.51; 3 RCTs). Comparison between moxibustion and knee-chest position did not show significant differences (RR 1.30, 95% CI 0.95 to 1.79; 3 RCTs). Moxibustion plus other therapeutic methods showed significant beneficial effects (RR 1.36, 95% CI 1.21 to 1.54; 2 RCTs). Laser stimulation was more effective than assuming the knee-chest position plus pelvis rotating. Moxibustion was more effective than no treatment (RR 1.29, 95% CI 1.17 to 1.42; 2 CCTs) but was not more effective than the knee-chest position treatment (RR 1.22, 95% CI 1.11 to 1.34; 2 CCTs). Laser stimulation at Zhiyin (BL67) was more effective than the knee-chest position treatment (RR 1.30, 95% CI 1.10 to 1.54; 2 CCTs,).Moxibustion, acupuncture and laser acupoint stimulation tend to be effective in the correction of breech presentation.Breech presentation (opposite direction of the normal position of the foetus) is common in the mid-trimester of pregnancy, with the incidence of breech decreasing as the pregnancy approaches term. The incidence of breech presentation at term is reported to be 4% [1]. Women with breech presentation face serious problems if delivering vaginally. Breech presentation may arise from placenta praevia, multiple gestation, uterine abnormalities, poor uterine tone, pre-maturity or unknown causes, and is associated with primi
A Novel Uni-Acupoint Electroacupuncture Stimulation Method for Pain Relief
Chuansen Niu,Hongwei Hao,Jun Lu,Luming Li,Zhirong Han,Ya Tu
Evidence-Based Complementary and Alternative Medicine , 2011, DOI: 10.1093/ecam/nep104
Abstract: Electroacupuncture stimulation (EAS) has been demonstrated effective for pain relief and treating other various diseases. However, the conventional way of EAS, the bi-acupoint method, is not suitable for basis study of acupoint specificity. Moreover, its operations are inconvenient and difficult to be persevered, especially for long-term, continuous and even imperative treatments. These disadvantages motivate designs of new EAS methods. We present a novel uni-acupoint electrical stimulation method, which is applied at a single acupoint and quite meets the needs of basis study and simpler clinical application. Its pain relief effect has been evaluated by animal tests of Wistar rats. During the experiments, rats were given 30 min 2/100 Hz uni- and bi-acupoint EAS and their nociceptive thresholds before and after EAS were attained by hot-plate test. The analgesic effect was defined as the change of nociceptive threshold and used to evaluate the effectiveness of uni-acupoint EAS for pain relief. The hot-plate test results indicated that analgesic effect of uni-acupoint group was significantly higher than that of the control group and there was no significant difference of analgesic effects between uni- and bi-acupoint EAS. The results suggested that uni-acupoint method was an effective EAS method and had comparable pain relief effect with bi-acupoint method.
Effects of transcutaneous electric acupoint stimulation on drug use and responses to cue-induced craving: a pilot study
David M Penetar, Anthony Burgos-Robles, George H Trksak, Robert R MacLean, Steven Dunlap, David Y-W Lee, Scott E Lukas
Chinese Medicine , 2012, DOI: 10.1186/1749-8546-7-14
Abstract: Volunteers who were either cocaine-dependent (n?=?9) or cannabis-dependent (n?=?11) but were not seeking treatment for their dependence participated in a within-subject, single-blind study. Treatment consisted of twice daily 30-minute sessions of TEAS or sham stimulation for 3.5?days. The active TEAS levels were individually adjusted to produce a distinct twitching response in the fingers, while the sham stimulation involved 2 minutes of stimulation at threshold levels followed by 28 minutes of stimulation below the detection levels. The participants recorded their drug use and drug cravings daily. At 1 hour after the last morning session of TEAS or sham stimulation, a cue-induced craving EEG evaluation was conducted. Event-related P300 potentials (ERPs) were recorded, sorted, and analyzed for specific image types (neutral objects, non-drug-related arousing images, or drug-related images).TEAS treatment did not significantly reduce the drug use or drug cravings, or significantly alter the ERP peak voltage or latency to peak response. However, the TEAS treatment did significantly modulate several self-reported measures of mood and anxiety.The results of this pilot study with a limited sample size suggest that the acupoint stimulation techniques and protocol used in this trial alone do not significantly reduce cravings for or use of cocaine or cannabis. The findings that TEAS modulates mood and anxiety suggest that TEAS could be used as an adjunct in a multimodal therapy program to treat cocaine and cannabis dependence if confirmed in a full randomized controlled clinical trial.Drug abuse and dependence are medical problems that have impacts on the personal, social, and economic fabric of society. Searches for effective therapies have been, and continue to be, important areas of research in neuroscience and pharmacology, as these disciplines seek to develop a greater understanding of the biological basis of drug abuse. Although there are several approved interventions
The effect of trancscutaneus electrical acupoint stimulation (TEAS) on fatigue reduction in hemodialysis patients  [PDF]
Fateme Hadadian,Sadighe fayazi,Ali Ghorbani,Habib Falah
Behbood , 2011,
Abstract: Background: Fatigue is one of the common complications in hemodialysis patients and may affect quality of life. The purpose of the study was to assess the effectiveness of Trancscutaneus Electrical Acupoint Stimulation (TEAS) on fatigue in these patients.Methods: In this quasi-experimental study all chronic hemodialysis patients referred into Hemodialysis unit during the study period were recruited. Among all patients, 45 subjects were selected fulfilling study criteria. Demographic data and Brief Fatigue Inventory (BFI) were collected before, after 5 and 10 session interventions. TEAS performed using ACUHEALTH set on 2.5 Hz for 5 minutes in Heugu, Saninjiao and Zusunlee acupoints within 10 sessions among dialysis treatment. Data was analyzed using Mc Nemar, Wilcoxcon and paired T test.Results: The results of study indicated that there was significant difference between averages of fatigue intensity, pretreatment, after 5 and 10 sessions of TEAS sequence (P<0 .0001 and P=0.001).Conclusion: Performing TEAS may decrease fatigue in chronic hemodialysis patients. This noninvasive and simple applicable method by nursing staffs for hemodialysis patient highly recommended to be used.
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