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Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT.

ABSTRACT: TREATMENT of patients with chronic low back pain (CLBP) aims to reduce disability, improve functional capacity, and participation. Time contingent prescription of analgesics is a treatment modality in CLBP. The impact of analgesics on functional capacity is unknown. Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation, and self-reported disability in patients with CLBP.Explorative Randomized Placebo-Controlled Clinical Trial was performed in an outpatient pain rehabilitation setting on patients waiting for rehabilitation. Included patients had low back pain lasting >3 months, visual analogue scale worst pain ?4.0 cm, and age >18 years. Outcome measures before (T0) and after treatment (T1): functional capacity, pain intensity, Roland Morris Disability Questionnaire. T1: global perceived pain relief. Patient characteristics and psychological questionnaires were assessed. Fifty patients were included in this study and were randomly assigned to 2 weeks treatment or placebo.acetaminophen/tramadol 325 mg/37.5 mg per capsule. Dose: maximum acetaminophen 1,950 mg and tramadol 225 mg per day; treatment and placebo titrated identically. Compliance and side-effects were monitored. TREATMENT effects between groups over time were compared.One patient (treatment group) was lost to follow-up. Forty-nine patients remained in the study. TREATMENT effects in primary outcomes did not differ significantly between groups. A subgroup of 10 (42%) patients (treatment group) reported global pain relief (responders) who reduced self-reported disability (p < 0.05). Responders had significantly lower catastrophizing scores.Overall treatment effects were small and non-significant. A subgroup, however, reported improved functioning as a result of treatment. Responders had lower catastrophizing scores.

SUBMITTER: Schiphorst Preuper HR

PROVIDER: S-EPMC3960442 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT.

Schiphorst Preuper Henrica R HR Geertzen Jan H B JH van Wijhe Marten M Boonstra Anne M AM Molmans Barbara H W BH Dijkstra Pieter U PU Reneman Michiel F MF

European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 20140215 4

<h4>Purpose</h4>TREATMENT of patients with chronic low back pain (CLBP) aims to reduce disability, improve functional capacity, and participation. Time contingent prescription of analgesics is a treatment modality in CLBP. The impact of analgesics on functional capacity is unknown. Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation, and self-reported disability in patients with CLBP.<h4>Methods</h4>Explorative Randomized Placebo-Con ...[more]

PMID: 24526247

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Project description:Low back pain (LBP) is a chronic disorder which exerts a profound impact on various spheres of psychosocial functioning, including emotional distress, functional limitations and decrements in social contacts. The objective of this study was to investigate the associations between the indices of psychosocial functioning in patients with chronic LBP and a range of psychological factors. Specifically, the study aimed at exploring the relative participation of personality, social support, disease-related cognitive appraisals and coping styles in accounting for the differences in psychosocial functioning of patients with LBP. One-hundred-twenty patients with LBP took part in the study and completed a battery of psychological questionnaires: NEO-Five Factors Inventory, Ways of Coping Questionnaire, Disease-Related Social Support Scale, Disease-Related Appraisals Scale and Psychosocial Functioning Questionnaire (PFQ). The PFQ dimensions were used as dependent variables in a series of stepwise regression analysis models with the scores from other questionnaires entered as independent variables. A cognitive appraisal of the disease in terms of an obstacle was strongly related to all domains of functioning; however, other appraisals (threat, challenge, harm, profit and overall disease importance) were uniquely associated with particular domains of functioning. Deprivation of social support was a significant predictor of distress experienced in interpersonal context and of sense of being disabled. Among basic personality traits, agreeableness was negatively associated with distress in interpersonal context, and conscientiousness was positively related to acceptance of life with the disease. Problem-focus coping was linked to higher acceptance of life with the disease. Among sociodemographic variables, older age and lower educational level were related to greater subjective feelings of being disabled. Pain severity was found unrelated to any of psychosocial functioning domains. Different aspects of psychosocial functioning are best accounted for by diverse patterns of psychological factors, which suggests involvement of different psychological mechanisms in development of LBP-related disability.

Project description:BackgroundChronic 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.ObjectiveThe aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain.MethodsIn 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.ResultsAfter 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.ConclusionsEAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs.Trial registrationClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.

Project description:BackgroundLow back pain (LBP) is a common musculoskeletal condition and a major cause of disability worldwide. Previous studies have found associations of biomarkers with pain and pain-related disability in LBP patients. This study aimed to explore the association between serum biomarkers and pain and disability in patients with acute or subacute axial LBP.MethodsThis study was ancillary to a parent randomized controlled trial. Enrolled participants were randomized into three intervention groups: one of two types of spinal manipulation or medical care. In the parent study, 107 adults who experienced a new episode of LBP within 3 months prior to enrollment were recruited. For this study, 90 of these 107 participants consented to have blood samples obtained, which were drawn immediately before the beginning of treatment. Seven biomarkers were chosen based on previous literature and analyzed. Clinical outcomes were pain and Oswestry Disability Index (ODI) evaluated at baseline and 4 weeks. Spearman's |r| was used to study the association of initial levels of each biomarker with pain and ODI scores at baseline and with changes in outcome scores from baseline to 4 weeks (end of treatment) within each intervention group.ResultsAt baseline, 4 of 7 biomarkers had an association with pain that was |r| ≥ .20: neuropeptide Y (NPY) (r = 0.23, p = .028), E-Selectin (r = 0.22, p = .043), vitamin D ((r = - 0.32, p = .002), and c-reactive protein (CRP) (r = 0.37, p = .001). No baseline biomarker had an association with disability that was |r| ≥ 0.20. For the correlations of baseline biomarkers with 4-week change in outcomes, vitamin D showed a correlation with change in disability and/or pain (|r| ≥ 0.20, p > .05) in manipulation-related groups, while CRP, NPY, and E-selectin along with TNFα, Substance P and RANTES showed at least one correlation with change in pain or disability (|r| ≥ 0.20, p > .05) in at least one of the treatment groups.ConclusionsIn 90 LBP patients, the analyzed biomarkers, especially vitamin D, represent a small set of potential candidates for further research aimed at individualizing patient care. Overall, the associations investigated in the current study are an initial step in identifying the direct mechanisms of LBP and predicting outcomes of manipulation-related treatments or medical care.Trial registrationClinicalTrials.gov Identifier: NCT01211613, Date of Registration: September 29, 2010, https://clinicaltrials.gov/ct2/show/NCT01211613?term=schneider&cond=Low+Back+Pain&cntry=US&state=US%3APA&draw=2&rank=1.

Dataset Information

Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT.

Publications

Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT.

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