Dataset Information

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617].

ABSTRACT:

Background

Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain.

Methods/design

This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain.

SUBMITTER: Hancock MJ

PROVIDER: S-EPMC1298305 | biostudies-literature | 2005 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617].

Hancock Mark J MJ Maher Christopher G CG Latimer Jane J McLachlan Andrew J AJ Cooper Chris W CW Day Richard O RO Spindler Megan F MF McAuley James H JH

BMC musculoskeletal disorders 20051110

<h4>Background</h4>Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain w ...[more]

PMID: 16280089

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Project description:BackgroundCurrent evidence suggests that spinal manipulative therapy (SMT) is effective in the treatment of people with low back pain (LBP); however, the corresponding mechanisms are unknown. Hypoalgesia is associated with SMT and is suggestive of specific mechanisms.ObjectiveThe primary purpose of this study was to assess the immediate effects of SMT on thermal pain perception in people with LBP. A secondary purpose was to determine whether the resulting hypoalgesia was a local effect and whether psychological influences were associated with changes in pain perception.DesignThis study was a randomized controlled trial.SettingA sample of convenience was recruited from community and outpatient clinics.ParticipantsThirty-six people (10 men, 26 women) currently experiencing LBP participated in the study. The average age of the participants was 32.39 (SD=12.63) years, and the average duration of LBP was 221.79 (SD=365.37) weeks.Intervention and measurementsBaseline demographic and psychological measurements were obtained, followed by quantitative sensory testing to assess temporal summation and Adelta fiber-mediated pain perception. Next, participants were randomly assigned to ride a stationary bicycle, perform low back extension exercises, or receive SMT. Finally, the same quantitative sensory testing protocol was reassessed to determine the immediate effects of each intervention on thermal pain sensitivity.ResultsHypoalgesia to Adelta fiber-mediated pain perception was not observed. Group-dependent hypoalgesia of temporal summation specific to the lumbar innervated region was observed. Pair-wise comparisons indicated significant hypoalgesia in participants who received SMT, but not in those who rode a stationary bicycle or performed low back extension exercises. Psychological factors did not significantly correlate with changes in temporal summation in participants who received SMT.LimitationsOnly immediate effects of SMT were measured, so the authors are unable to comment on whether the inhibition of temporal summation is a lasting effect. Furthermore, the authors are unable to comment on the relationship between their findings and changes in clinical pain.ConclusionsInhibition of Adelta fiber-mediated pain perception was similar for all groups. However, inhibition of temporal summation was observed only in participants receiving SMT, suggesting a modulation of dorsal horn excitability that was observed primarily in the lumbar innervated area.

Project description:Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 - -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Project description:BackgroundLow back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear.MethodsWe conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4-12) and long-term (week 4-52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration.Results241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone.ConclusionsAdding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care.Trial registrationNCT00269321.

Project description:BackgroundThe inflammatory profiles of patients with acute and chronic nonspecific low back pain (LBP) patients are distinct. Spinal manipulative therapy (SMT) has been shown to modulate the production of nociceptive chemokines differently in these patient cohorts. The present study further investigates the effect(s) of SMT on other inflammatory mediators in the same LBP patient cohorts.MethodsAcute (n = 22) and chronic (n = 25) LBP patients with minimum pain scores of 3 on a 10-point numeric scale, and asymptomatic controls (n = 24) were recruited according to stringent exclusion criteria. Blood samples were obtained at baseline and after 2 weeks during which patients received 6 SMTs in the lumbar or lumbosacral region. The in vitro production of tumor necrosis factor (TNFα), interleukin-1 β (IL-1β), IL-6, IL-2, interferon ɣ (IFNɣ), IL-1 receptor antagonist (IL-1RA), TNF soluble receptor type 2 (sTNFR2) and IL-10 was determined by specific immunoassays. Parametric as well as non-parametric statistics (PAST 3.18 beta software) was used to determine significance of differences between and within study groups prior and post-SMT. Effect size (ES) estimates were obtained using Cohen's d.ResultsCompared with asymptomatic controls, SMT-related change scores were significant (P = 0.03-0.01) in reducing the production levels of TNFα in both patient cohorts and those of IL-6, IFNɣ and sTNFR2 (P = 0.001-0.02) in patients with chronic LBP. Above-moderate to large ES (d > 0.6-1.4) was observed for these mediators. Compared with respective baselines, a significant post-SMT reduction (P = 0.01) of IL-6 production was detected only in patients with chronic LBP while a significant increase of IL-2 production (P = 0.001 vs. control, and P = 0.004 vs. chronic LBP group) and a large ES (d = 0.87) were observed in patients with acute LBP. Pain and disability scores declined significantly (P < 0.001) in all LBP patients, and were positively correlated (P = 0.03) with IFNɣ and IL-2 levels in the acute LBP cohort.ConclusionThe short course of SMT treatments of non-specific LBP patients resulted in significant albeit limited and diverse alterations in the production of several of the mediators investigated in this study. This exploratory study highlights the potential of SMT to modulate the production of inflammatory components in acute and chronic non-specific LBP patients and suggests a need for further, randomized controlled clinical trials in this area.Trial registrationThis study was prospectively registered April 2012 with Clinical Trials.gov ( #NCT01766141 ). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0003ZIL&selectaction=Edit&uid=U0001V74&ts=2&cx=-axvqtg.

Dataset Information

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617].

Background

Methods/design

Publications

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617].

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