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Quality of life and functional outcomes with tapentadol prolonged release in chronic musculoskeletal pain: post hoc analysis.
Ferri, CM, Natoli, S, Sanz-Ayan, P, Magni, A, Guerrero, C, Lara-Solares, A, Liedgens, H, Thömmes, G, Karra, R
Pain management. 2021;(2):173-187
Abstract
Aims: To investigate quality of life (QOL) and functionality changes in chronic pain during tapentadol prolonged release (PR) treatment. Patients & methods: Post hoc analysis of data from three Phase III trials in patients with osteoarthritis knee pain or low back pain. QOL and functionality changes were assessed by SF-36 scores. Results: All SF-36 subdomain scores improved progressively to week 3 of tapentadol titration and were sustained during 12-week maintenance treatment. Improvements in SF-36 scores were similar between tapentadol dose groups (e.g., 200 to <300 mg vs ≥500 mg), with no greater effect from higher doses. QOL and functionality improvements were consistently greater with tapentadol PR than oxycodone controlled release. Conclusion: Tapentadol PR provides consistent, clinically relevant improvements in QOL and functionality in chronic pain.
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A novel (targeted) kinesio taping application on chronic low back pain: Randomized clinical trial.
Peñalver-Barrios, ML, Lisón, JF, Ballester-Salvador, J, Schmitt, J, Ezzedinne-Angulo, A, Arguisuelas, MD, Doménech, J
PloS one. 2021;(5):e0250686
Abstract
The aim of the present clinical trial is to evaluate the efficacy of kinesio taping on patients with chronic low back pain, when the exploration identifies skin/fascia mobilization as a factor that could modify the treatment effect. This study is a randomized controlled trial with intention-to-treat analysis. Sixty-two participants with chronic low back pain were therefore recruited from a tertiary referral hospital. Targeted kinesio taping, according to skin/fascia mobility exploration, was applied in the experimental group (17 female/13 male; 49.47 ± 11.15 years) once a week for four sessions. The control group (17 female/14 male; 48.87 ± 9.09 years) underwent a placebo taping application. At post-treatment time there was a statistically significant reduction both in disability (Roland-Morris Disability Questionnaire) and pain (Numeric Pain Rating Scale) in the experimental group (disability: -2.88, 95% confidence interval [CI] -4.56 to -1.21, P < .001; pain: -1.58, 95% CI -2.67 to -0.54 P = .001) and the control group (disability: -1.82, 95% CI -3.46 to -0.17 P = .025; pain: -1.30, 95% CI -2.32 to -0.28 P = .008). However, at six months, these changes only remained significant in the experimental group (disability: -2.95, 95% CI -4.72 to -1.18, P < .001; pain: -1.06, 95% CI -2.07 to -0.04, P < .05). As a conclusion, the application of targeted kinesio taping produced a significant reduction in pain and disability, at 4 weeks and at 6 moths follow-up, although there were no differences between groups at any measurement time point.
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Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis.
Calderon-Ospina, CA, Nava-Mesa, MO, Arbeláez Ariza, CE
Pain medicine (Malden, Mass.). 2020;(4):766-781
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BACKGROUND Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management. METHODS We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis. RESULTS Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P < 0.00001). We found no differences in the safety profile and patient satisfaction. CONCLUSIONS This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.
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Gluteus medius muscle function in people with and without low back pain: a systematic review.
Sadler, S, Cassidy, S, Peterson, B, Spink, M, Chuter, V
BMC musculoskeletal disorders. 2019;(1):463
Abstract
INTRODUCTION Globally, low back pain (LBP) is one of the greatest causes of disability. In people with LBP, dysfunction of muscles such as the gluteus medius have been demonstrated to increase spinal loading and reduce spinal stability. Differences in gluteus medius function have been reported in those with LBP compared to those without, although this has only been reported in individual studies. The aim of this systematic review was to determine if adults with a history, or current LBP, demonstrate differences in measures of gluteus medius function when compared to adults without LBP. METHODS MEDLINE, EMBASE, AMED, PsycINFO, PubMED, Pro Quest Database, CINAHL and SPORTDiscus were searched from inception until December 2018 for published journal articles and conference abstracts. No language restrictions were applied. Only case-control studies with participants 18 years and over were included. Participants could have had any type and duration of LBP. Studies could have assessed gluteus medius function with any quantifiable clinical assessment or measurement tool, with the participant non-weight bearing or weight bearing, and during static or dynamic activity. Quality appraisal and data extraction were independently performed by two authors. RESULTS The 24 included articles involved 1088 participants with LBP and 998 without LBP. The gluteus medius muscle in participants with LBP tended to demonstrate reduced strength and more trigger points compared to the gluteus medius muscle of those without LBP. The level of activity, fatigability, time to activate, time to peak activation, cross sectional area, and muscle thickness showed unclear results. Meta-analysis was not performed due to the heterogeneity of included studies. CONCLUSION Clinically, the findings from this systematic review should be considered when assessing and managing patients with LBP. Future studies that clearly define the type and duration of LBP, and prospectively assess gluteus medius muscle function in those with and without LBP are needed. TRIAL REGISTRATION PROSPERO ( CRD42017076773 ).
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Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial.
Robson, EK, Kamper, SJ, Davidson, S, Viana da Silva, P, Williams, A, Hodder, RK, Lee, H, Hall, A, Gleadhill, C, Williams, CM
BMJ open. 2019;(9):e029290
Abstract
INTRODUCTION Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER ACTRN12617001288314.
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Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial.
Kamada, M, Kitayuguchi, J, Abe, T, Taguri, M, Inoue, S, Ishikawa, Y, Bauman, A, Lee, IM, Miyachi, M, Kawachi, I
International journal of epidemiology. 2018;(2):642-653
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BACKGROUND Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. METHODS We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40-79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78-83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. RESULTS Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3-3.4%, P ≥ 0.138). Linear dose-response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. CONCLUSIONS The 5-year CWI using the focused social marketing strategy increased the population-level of PA.
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Reducing sedentary behaviour to decrease chronic low back pain: the stand back randomised trial.
Barone Gibbs, B, Hergenroeder, AL, Perdomo, SJ, Kowalsky, RJ, Delitto, A, Jakicic, JM
Occupational and environmental medicine. 2018;(5):321-327
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OBJECTIVE The Stand Back study evaluated the feasibility and effects of a multicomponent intervention targeting reduced prolonged sitting and pain self-management in desk workers with chronic low back pain (LBP). METHODS This randomised controlled trial recruited 27 individuals with chronic LBP, Oswestry Disability Index (ODI) >10% and desk jobs (sitting ≥20 hours/week). Participants were randomised within strata of ODI (>10%-<20%, ≥20%) to receive bimonthly behavioural counselling (in-person and telephone), a sit-stand desk attachment, a wrist-worn activity-prompting device and cognitive behavioural therapy for LBP self-management or control. Self-reported work sitting time, visual analogue scales (VAS) for LBP and the ODI were assessed by monthly, online questionnaires and compared across intervention groups using linear mixed models. RESULTS Baseline mean (SD) age was 52 (11) years, 78% were women, and ODI was 24.1 (10.5)%. Across the 6-month follow-up in models adjusted for baseline value, work sitting time was 1.5 hour/day (P<0.001) lower comparing intervention to controls. Also across follow-up, ODI was on average 8 points lower in intervention versus control (P=0.001). At 6 months, the relative decrease in ODI from baseline was 50% in intervention and 14% in control (P=0.042). LBP from VAS was not significantly reduced in intervention versus control, though small-to-moderate effect sizes favouring the intervention were observed (Cohen's d ranged from 0.22 to 0.42). CONCLUSION An intervention coupling behavioural counselling targeting reduced sedentary behaviour and pain self-management is a translatable treatment strategy that shows promise for treating chronic LBP in desk-bound employees. TRIAL REGISTRATION NUMBER NCT0224687; Pre-results.
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Effect of Different Volumes on Pain Relief in Patient Receiving Fluoroscopic Guided Interlaminar Lumbar Epidural Steroid Injection.
Makkar, JK, Kumar, B, Jain, K, Dhutt, SS, Batra, YK, Singh, PM
Pain physician. 2018;(3):243-250
Abstract
BACKGROUND Epidural steroids injections (ESI) are frequently used to treat lumbar radicular pain. Although different volume have been used for interlaminar ESI in adults, there is no controlled trial comparing the effect of different volumes on pain relief for the same dose of steroid . OBJECTIVE To compare the effect of increase in volume of epidural drug on pain relief in lumbar ESI. STUDY DESIGN Randomized double blind trial SETTING Pain OR of a tertiary care centre METHODS Sixty patients were randomly allocated to 1 of 3 groups: Group A (4 mL), Group B (6 mL), and Group C (8 mL). Pain was evaluated using visual analog scale (VAS) and improvement in disability using modified Oswestry Disability Questionnaire scores (MODQS) at 2, 4, 8, 12, and 24 weeks. Patients having less than 50% pain relief from baseline received an additional epidural injection of the same volume with a maximum of 3 injections at least 15 days apart. The primary objective of the study was incidence of patients attaining more than 50% pain relief at 6 months. Secondary outcome included MODQS and pattern of spread of iodinated contrast on fluoroscopy. RESULTS At the end of 6 months, there was no significant difference in the effective pain relief between the 3 groups (Group A-16/22 (72.7%), Group B-15/20 (75%), Group C-13/18 (72.2%); P = 0.98, chi- square test). All groups demonstrated a significant reduction in mean VAS scores. There was no significant intergroup difference in VAS sores and MODQS at all the time intervals. The pattern of contrast spread did not differ between the 3 groups. LIMITATION Not a placebo controlled trial. CONCLUSIONS An increase in volume of the injectate from 4 mL to 8 mL did not increase the efficacy of interlaminar ESI. KEY WORDS Epidural steroid, volume, low back pain, interlaminar.
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Transforaminal lumbar interbody fusion using polyetheretherketone oblique cages with and without a titanium coating: a randomised clinical pilot study.
Rickert, M, Fleege, C, Tarhan, T, Schreiner, S, Makowski, MR, Rauschmann, M, Arabmotlagh, M
The bone & joint journal. 2017;(10):1366-1372
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AIMS: We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). MATERIALS AND METHODS We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months. RESULTS At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups. CONCLUSION Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: Bone Joint J 2017;99-B:1366-72.
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Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis.
Lee, H, Wiggers, J, Kamper, SJ, Williams, A, O'Brien, KM, Hodder, RK, Wolfenden, L, Yoong, SL, Campbell, E, Haskins, R, et al
BMJ open. 2017;(6):e014652
Abstract
INTRODUCTION Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. METHODS AND ANALYSIS Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. ETHICS AND DISSEMINATION The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER ACTRN12615000490572 and ACTRN12615000478516; Pre-results.