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A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

ABSTRACT: BACKGROUND:Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS:A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS:At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS:Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

SUBMITTER: Cherkin DC

PROVIDER: S-EPMC2832641 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

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A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

Cherkin Daniel C DC Sherman Karen J KJ Avins Andrew L AL Erro Janet H JH Ichikawa Laura L Barlow William E WE Delaney Kristin K Hawkes Rene R Hamilton Luisa L Pressman Alice A Khalsa Partap S PS Deyo Richard A RA

Archives of internal medicine 20090501 9

<h4>Background</h4>Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.<h4>Methods</h4>A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupunc ...[more]

PMID: 19433697

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Project description:BackgroundThe collaborative treatment of acupuncture in addition to routine care as an approach for the management of low back pain (LBP) is receiving increasing recognition from both public and professional arenas. In 2010, the Ministry of Health, Welfare and Family Affairs (MOHW) of South Korea approved the practice of doctors and Oriental medical doctors (acupuncture qualified) working together in the same facility and offering collaborative treatment at the same time for the same disease. However, there is little more than anecdotal evidence on the health and economic implications of this current practice. Therefore, the objective of this study is to examine the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic LBP patients in South Korea.MethodsThe Markov model was developed to synthesise evidence on both costs and outcomes for patients with chronic LBP. We conducted the base case analysis, univariate and probabilistic sensitivity analyses, and also performed the value of information analysis for future researches. Model parameters were sourced from systematic review of both alternatives, simple bibliographic reviews of relevant articles published in English or Korean, and statistical analyses of the 2005 and 2007 Korean National Health and Nutrition Survey (KNHNS) data. The analyses were based on the societal perspective over a five year time horizon using a 5% discount rate.ResultsIn the base case, collaborative treatment resulted in better outcomes, but at a relatively high cost. Overall, the incremental cost-effectiveness ratio of a collaborative practice was 3,421,394 KRW (Korean rate Won) per QALY (Quality adjusted life year) (2,895.80 USD per QALY). Univariate sensitivity analysis of indirect non-medical costs did not affect the preference order of the strategies. Probabilistic sensitivity analysis revealed that if the threshold was over 3,260,000 KRW per QALY (2,759.20 USD per QALY), the probability for cost-effectiveness of a collaborative practice would exceed 50%. At 20,000,000 KRW per QALY, which is recommended using per capita gross domestic product (GDP) as the threshold, the probability would be 72.3%.ConclusionsOn the basis of our findings, acupuncture collaborative therapy for patients with chronic LBP may be cost-effective if the usual threshold is applied. Further empirical studies are required to overcome the limitations of uncertainties and improve the precision of the results.

Project description:ObjectiveChronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain.MethodsThis study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes.ResultsSixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01).ConclusionsNaturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.Trial registrationControlled-Trials.com ISRCTN41920953.

Project description:Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain.A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain.Clinical Trials.gov NCT00065585.

Project description:BACKGROUND:Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use. OBJECTIVE:The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. METHODS:In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits. RESULTS:After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups. CONCLUSIONS:EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. TRIAL REGISTRATION:ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.

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A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

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A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

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