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Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol.

ABSTRACT: Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability.This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI) value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID) injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS) of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR). Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.The results of this trial will be discussed.ClinicalTrial.gov NCT01315561.

SUBMITTER: Shin JS

PROVIDER: S-EPMC3262760 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol.

Shin Joon-Shik JS Ha In-Hyuk IH Lee Tae-Gyu TG Choi Youngkwon Y Park Byoung-Yoon BY Kim Me-riong MR Lee Myeong Soo MS

BMC complementary and alternative medicine 20111213

<h4>Background</h4>Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability.<h4>Methods/de ...[more]

PMID: 22151475

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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:BackgroundSpondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis.Methods/designThe study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation).DiscussionThis randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis.Trial registrationThis trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.

Project description:BackgroundPain-related self-efficacy is defined as the beliefs held by people with chronic pain that certain activities can be carried out despite the pain. Poor self-efficacy is an obstacle to the recovery and predicts long-term disability. The aims of this study are to investigate the prevalence of poor pain self-efficacy in Italian subjects with chronic low back pain (LBP), and to inquire the relationships between self-efficacy, disability, pain, and main demographic and clinical characteristics.MethodsA secondary multicenter retrospective analysis was done on 310 outpatients with chronic non-specific LBP. The pain self-efficacy measured with the Pain Self-Efficacy Questionnaire (PSEQ), the disability measured with the Roland & Morris Disability Questionnaire, and the pain intensity measured with the Numerical Rating Scale were considered variables to investigate, whereas demographic and clinical variables were considered predictors or potential confounders. A 40/60 PSEQ score was adopted as cut-off to distinguish between good and poor self-efficacy.Results199 subjects (64.2% of the sample) showed poor self-efficacy. The odds of having poor self-efficacy appeared significantly related to female gender (OR = 1.80, 95%CI [1.12;2.90]; p = 0.015) and drugs use (OR = 1.68, 95%CI [1.06;2.70]; p = 0.029). Significant relationships also emerged between disability and higher age (β = 0.07, 95%CI [0.01; 0.12]; p = 0.02), being female (β = 1.80, 95%CI [0.32;3.29]; p = 0.018), low educational level (β = - 1.68, 95%CI [- 2.59;-3.29]; p < 0.001), higher height (β = - 0.08, 95%CI [- 0.158;-0.002]; p = 0.045), pain duration [mos] (β = 0.01, 95%CI [0.001;0.021]; p = 0.041), and drugs use (β = 2.86, 95%CI [1.44;4.27]; p < 0.001). The amount of pain appeared significantly related to educational level (β = - 0.47, 95%CI [- 0.76;-0.182]; p < 0.001), smoking (β = 0.56, 95%CI [0.09; 1.03]; p = 0.021), height (β = - 0.03, 95%CI [- 0.05; - 0.002]; p = 0.036), and drugs use (β = 0.81, 95%CI [0.399;1.22]; p < 0.001). No significant correlation appeared among weight, body mass index, and referred pain neither in relation to self-efficacy, nor in relation to pain/disability.ConclusionsThe majority of our sample, composed of Italian people complained of chronic LBP, shows poor self-efficacy. Female gender and drugs use are significantly related to poor self-efficacy, low educational level negatively influences the amount of perceived pain and disability, and older age and smoking are related to disability and pain intensity, respectively. The knowledge of these sociodemographic and clinical characteristics potentially influencing chronic LBP may be useful to address more efforts towards the most negatively impacted subjects, among the entire population complained of chronic LBP.

Project description:BackgroundAcupuncture 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.MethodsA 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.ResultsAt 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).ConclusionsAlthough 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.

Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.

Dataset Information

Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol.

Publications

Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol.

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