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Efficacy and tolerability of orally administered tramadol/dexketoprofen fixed-dose combination compared to diclofenac/thiocolchicoside in acute low back pain: experience from an Italian, single-centre, observational study.
Meloncelli, S, Divizia, M, Germani, G
Current medical research and opinion. 2020;(10):1687-1693
Abstract
OBJECTIVES To compare the analgesic efficacy and tolerability of tramadol/dexketoprofen 75/25 mg (TRAM/DKP) versus diclofenac/thiocolchicoside 75/4 mg (DIC/THIO) in patients with moderate-to-severe acute low back pain (LBP). METHODS Single-centre, observational study in 82 adult outpatients with LBP due to disc herniation (≥4 Numerical Rating scale, NRS) who received either oral TRAM/DKP (n = 44) or intramuscular DIC/THIO (n = 38), both given every 12 h for 5 days. The primary endpoint was the change from baseline in pain intensity (PI) at pre-specified post-dose time points (t day1, t day3, t day7) and compared between the two treatments. Additional endpoints, all evaluated at day 7, included: the sum of PI difference (SPID), percentage of responders in terms of PI reduction versus baseline and change from baseline in Douleur Neuropathique (DN4) score. Tolerability and safety were also assessed. RESULTS Both treatment groups were comparable for demographic characteristics and comorbidities. Over the 5-day treatment period and up to day 7, compared to DIC/THIO, TRAM/DKP provided a significantly greater and sustained analgesia at day 3 and day 7 (p < .0001), with a higher proportion of responders at each time point [75% versus 71.1% (p = 0.687) at day 1, 93.2% versus 73.7% at day 3 (p = .016) and 95.5% versus 71.1% at day 7 (p = .003)], higher values of SPID (770.9 ± 23.5 vs. 507.1 ± 22.6; p < .0001) and significantly greater reduction in DN4 score [-62.7 ± 25.6 vs. -39.7 ± 31.2 (p < .0001)]. Both treatments were well tolerated. CONCLUSIONS Orally administered TRAM/DKP 75/25 mg can be a valuable and effective option in patients with acute LBP.
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Feasibility and impact of sit-stand workstations with and without exercise in office workers at risk of low back pain: A pilot comparative effectiveness trial.
Johnston, V, Gane, EM, Brown, W, Vicenzino, B, Healy, GN, Gilson, N, Smith, MD
Applied ergonomics. 2019;:82-89
Abstract
The aim of this study was to compare the feasibility and impact of sit-stand workstations plus advice, with or without exercise, on back pain and sitting time in office workers at risk of low back pain (LBP). Eligible participants (n = 29/169; 17% overall) were randomized to receive a sit-stand workstation and advice with (n = 16) or without (n = 13) progressive resistance exercise training for 4-weeks. Feasibility (recruitment, acceptability, adherence) and impact (LBP severity during a standardized standing task, workplace-sitting time) were assessed. Intervention acceptability (87.5% very satisfied) was good and adherence (60% completed all 12 exercise sessions) was satisfactory. Maximum LBP severity (mean difference of -1.3 (-2.0, -0.6) and workplace sitting time (82.7-99.3 min/8-hr workday reduction) were similarly reduced in both groups. The introduction of a sit-stand workstation with advice was feasible and achieved similar outcomes for LBP and workplace sitting time when administered with or without exercise.
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A comparison of water-based and land-based core stability exercises in patients with lumbar disc herniation: a pilot study.
Bayraktar, D, Guclu-Gunduz, A, Lambeck, J, Yazici, G, Aykol, S, Demirci, H
Disability and rehabilitation. 2016;(12):1163-71
Abstract
PURPOSE To determine and compare the effects of core stability exercise programs performed in two different environments in lumbar disc herniation (LDH) patients. METHOD Thirty-one patients who were diagnosed with LDH and were experiencing pain or functional disability for at least 3 months were randomly divided into two groups as land-based exercises or water specific therapy. Also, 15 age-sex-matched healthy individuals were recruited as healthy controls. Both groups underwent an 8-week (3 times/week) core stabilization exercise program. Primary outcomes were pain, trunk muscle static endurance and perceived disability level. The secondary outcome was health-related quality of life. RESULTS Level of static endurance of trunk muscles was found to be lower in the patients compared to the controls at baseline (p < 0.05). Both treatment groups showed significant improvements in all outcomes (p < 0.05) after 8-week intervention. When two treatment groups were compared, no differences were found in the amount of change after the intervention (p > 0.05). After the treatment, static endurance of trunk muscles of the LDH patients became similar to controls (p > 0.05). CONCLUSION According to these results, core stabilization exercise training performed on land or in water both could be beneficial in LDH patients and there is no difference between the environments. IMPLICATIONS FOR REHABILITATION An 8-week core stabilization program performed in water or on land decrease pain level and improve functional status in LDH patients. Both programs seem beneficial to increase health-related quality of life and static endurance of trunk muscles. Core stability exercises could be performed in water as well, no differences were found between methods due to environment.
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[Surgical treatment of degenerative lumbar instability by minimally invasive transforaminal lumbar interbody fusion].
Liang, B, Yin, G, Zhao, J, Li, N, Hu, Z
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2011;(12):1449-54
Abstract
OBJECTIVE To investigate the effectiveness of surgical treatment for single-level degenerative lumbar instability (DLI) by comparing traditional open transforaminal lumbar interbody fusion (TLIF) with minimally invasive TLIF. METHODS Between March 2007 and May 2009, 87 patients with single-level DLI were treated by traditional open TLIF (group A, n = 45) and by minimally invasive TLIF (group B, n = 42), respectively. There was no significant difference in gender, age, disease duration, segment level, combined diseases of lumbar spine, or the proportion of uni- and bilateral symptom between 2 groups (P > 0.05). The indexes of surgical trauma, systemic inflammatory response, clinical outcomes, and paravertebral muscle injury were compared between 2 groups. RESULTS Operation was performed successfully in all patients. The patients were followed up 2.9 years on average in group A and 2.8 years on average in group B. The incision, blood loss, and postoperative drainage in group B were significantly less than those in group A (P < 0.05), but the operation time in group B was significantly longer than that in group A (P < 0.05). There were significant differences (P < 0.05) in C-reactive protein, leucocyte count, and creatine kinase MM between 2 groups at 24 hours postoperatively as well as in C-reactive protein at 6 days postoperatively; group B was superior to group A. At last follow-up, the Oswestry disability index (ODI) and visual analogue score (VAS) were significantly improved when compared with the preoperative scores in 2 groups (P < 0.05). There were significant differences in ODI and back pain VAS score (P < 0.05), but no significant difference in leg pain VAS score (P > 0.05) between 2 groups. At last follow-up, no low back pain occurred in 8 and 18 cases, mild in 25 and 18 cases, moderate in 9 and 6 cases, and severe in 3 and 0 cases in groups A and B, respectively, showing that low back pain was significantly lighter in group B than in group A (Z = 2.574, P = 0.010). At last follow-up, the atrophy ratio of multifidus muscle was 37% +/- 13% in group A and was 15% +/- 7% in group B, showing significant difference (t = 12.674, P = 0.000). The multifidus muscle atrophy was rated as grade I in 18 and 44 sides, as grade II in 42 and 32 sides, and as grade III in 30 and 8 sides in groups A and B, respectively, showing significant difference (Z = -4.947, P = 0.000). CONCLUSION Both traditional open TLIF and minimally invasive TLIF are the effective treatments for single-level DLI. Minimally invasive TLIF has less surgical trauma, slighter postoperative systemic inflammatory response, less paravertebral muscle injury, and lower incidence of postoperative back pain, but it has longer operation time.
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Comparison of paraspinal muscle injury in one-level lumbar posterior inter-body fusion: modified minimally invasive and traditional open approaches.
Fan, SW, Hu, ZJ, Fang, XQ, Zhao, FD, Huang, Y, Yu, HJ
Orthopaedic surgery. 2010;(3):194-200
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Abstract
OBJECTIVE To determine differences in paraspinal muscle injury between a modified minimally invasive approach (MMIA) and a traditional operative approach (TOPA) for one-level instrumented posterior lumbar inter-body fusion (PLIF). METHODS From March 2006 to May 2008, a consecutive series of 91 patients who underwent a one-level instrumented PLIF procedure using one of two different approaches (MMIA in 41 patients and TOPA in 50), and who were operated on by one group of surgeons at a single institution, was studied. The following data were compared between the two groups: surgical time, blood loss, and changes in postoperative serum concentration of creatinine kinase (CK). More than 1 year post operation, low back pain was evaluated by a visual analog scale (VAS) and the Oswestry disability index (ODI). Some patients were also evaluated by MRI to allow comparison of the preoperative and postoperative cross sectional area (CSA) and fat degeneration grades at the operative level. RESULTS There was no statistically significant difference in surgical time, but blood loss, serum concentration of CK, and scores of the VAS and ODI were markedly less in the MMIA group compared with the TOPA group. In the TOPA group, the postoperative CSA of the multifidus muscles was significantly smaller than it was pre-operatively. In contrast, there was no significant difference between the pre- and post-operative CSA of the multifidus muscles in the MMIA group. There was more fatty infiltration postoperatively than preoperatively in both the TOPA and MMIA groups, the increase in fatty infiltration being greater in the TOPA than in the MMIA group. CONCLUSION Compared with TOPA, MMIA can significantly lessen paraspinal muscle injury, and reduce the incidence of low back pain.
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Self-management practices among primary care patients with musculoskeletal pain and depression.
Damush, TM, Wu, J, Bair, MJ, Sutherland, JM, Kroenke, K
Journal of behavioral medicine. 2008;(4):301-7
Abstract
The objective of this study was to assess the effect of clinical depression on pain self-management practices. We employed a cross-sectional analysis of baseline data from the Stepped Care for Affective disorders and Musculoskeletal Pain (SCAMP) study. Participants included 250 patients with pain and comorbid depression and 250 patients with pain only and were enrolled from urban university and VA primary care clinics. Musculoskeletal pain was defined as low back, hip or knee pain present >or=3 months and with at least a moderate, Brief Pain Inventory severity score >or=5. Depression was defined as a PHQ-9 score >or=10. We used multiple logistic and Poisson regression to assess the relationship between individual and combined effects of depression and pain severity on two core pain self-management skills: exercise duration and cognitive strategies. Depressed patients exercised less per week than did nondepressed patients but showed a trend towards more frequent use of cognitive strategies. On multivariable analysis, depression severity substantially decreased the use of exercise as a pain self-management strategy. In contrast, depression and pain severity interacted to increase the use of cognitive strategies. Depression and pain severity have differential effects on self-management practices. Understanding the differences between preferential strategies of pain patients with and without depression may be useful in tailoring pain self-management programs.
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A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain.
Zippel, H, Wagenitz, A
Clinical drug investigation. 2007;(8):533-43
Abstract
BACKGROUND Low back pain is an important medical problem in Western industrialised countries. NSAIDs are one of the main options for symptomatic pain relief in the early management of this painful condition. Dexketoprofen is an NSAID belonging to the arylpropionic acid group that has demonstrated good analgesic efficacy and a good safety profile in different acute and chronic painful conditions. METHODS A randomised, double-blind, parallel, active controlled, multicentre study that included 370 outpatients with acute low back pain was conducted to compare the analgesic efficacy of dexketoprofen 50mg twice daily versus diclofenac 75mg twice daily administered intramuscularly for 2 days. Efficacy outcomes were assessment of pain intensity (PI) measured on a visual analogue scale, total PI scores from baseline to 6 hours after the first-dose administration (primary efficacy endpoint; SAPID(0-6)), score on a physical disability scale using the Roland Disability Questionnaire (RDQ), and use of rescue medication. Tolerability and safety were also assessed as secondary variables. RESULTS The adjusted mean (SAPID(0-6)) scores were very similar, 117.3 mm/h with dexketoprofen and 114.7 mm/h with diclofenac. The adjusted ratio of means was 1.023 and the lower 95% confidence limit was 0.81, demonstrating non-inferiority of dexketoprofen (defined by a lower limit of the 95% CI >0.80) in comparison with diclofenac (per-protocol analysis). The median change in the RDQ was -6 points for both groups (p = 0.69), showing an overall improvement on the disability scale. No significant differences between groups were observed regarding the percentage of patients needing rescue medication or in the mean values of pain after repeated doses (SAPID(0-last)). Dexketoprofen was well tolerated, with a reported incidence of adverse events similar to that of diclofenac. No serious adverse events were reported in either treatment group. CONCLUSION From the results of this study it can be concluded that dexketoprofen 50mg administered twice daily intramuscularly provides a clinically relevant analgesic effect with good tolerability after single and repeated doses in patients with acute severe low back pain.
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Harpgophytum procumbens for osteoarthritis and low back pain: a systematic review.
Gagnier, JJ, Chrubasik, S, Manheimer, E
BMC complementary and alternative medicine. 2004;:13
Abstract
BACKGROUND The objective of this review is to determine the effectiveness of Harpagophytum procumbens preparations in the treatment of various forms of musculoskeletal pain. METHODS Several databases and other sources were searched to identify randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials testing Harpagophytum preparations in adults suffering from pain due to osteoarthritis or low back pain. RESULTS Given the clinical heterogeneity and insufficient data for statistical pooling, trials were described in a narrative way, taking into consideration methodological quality scores. Twelve trials were included with six investigating osteoarthritis (two were identical trials), four low back pain, and three mixed-pain conditions. CONCLUSIONS There is limited evidence for an ethanolic Harpagophytum extract containing less than <30 mg harpagoside per day in the treatment of knee and hip osteoarthritis. There is moderate evidence of effectiveness for (1) the use of a Harpagophytum powder at 60 mg harpagoside in the treatment of osteoarthritis of the spine, hip and knee; (2) the use of an aqueous Harpagophytum extract at a daily dose of 100 mg harpagoside in the treatment of acute exacerbations of chronic non-specific low back pain; and (3) the use of an aqueous extract of Harpagophytum procumbens at 60 mg harpagoside being non-inferior to 12.5 mg rofecoxib per day for chronic non-specific low-back pain (NSLBP) in the short term. Strong evidence exists for the use of an aqueous Harpagophytum extract at a daily dose equivalent of 50 mg harpagoside in the treatment of acute exacerbations of chronic NSLBP.
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A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain.
Chrubasik, S, Model, A, Black, A, Pollak, S
Rheumatology (Oxford, England). 2003;(1):141-8
Abstract
OBJECTIVE This randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain was aimed to inform a definitive comparison between Doloteffin, a proprietary extract of Harpagophytum, and rofecoxib, a selective inhibitor of cyclo-oxygenase-2 (COX-2). METHODS Forty-four patients (phyto-anti-inflammatory drug-PAID-group) received a daily dose of Doloteffin containing, inter alia, 60 mg of harpagoside for 6 weeks and 44 (non-steroidal anti-inflammatory drug-NSAID-group) received 12.5 mg/day of rofecoxib. All were allowed rescue medication of up to 400 mg/day of tramadol. Several outcome measures were examined at various intervals to obtain estimates of effect size and variability that might be used to decide the most suitable principal outcome measure and corresponding numbers required for a definitive study. RESULTS Forty-three PAID and 36 NSAID patients completed the study. Ten PAID and 5 NSAID patients reported no pain without rescue medication for at least 5 days of the 6th week of treatment. Eighteen PAID and 12 NSAID patients had more than a 50% reduction in the week's average of their pain scores between the 1st and 6th weeks. The mean percentage decrease from baseline in the pain component of the Arhus Index was 23 (S.D. 52) in PAID and 26 (S.D. 43) in NSAID. The corresponding measures for the overall Arhus Index were 11 (31) and 16 (24) and, for the Health Assessment Questionnaire, 7 (8) and 6 (7). Tramadol was used by 21 PAID patients and 13 NSAID patients. Fourteen patients in each group experienced 39 adverse effects, of which 28 (13 in PAID) were judged to some degree attributable to the study medications. CONCLUSION Though no significant intergroup differences were demonstrable, large numbers will be needed to show equivalence.
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[Dexketoprofen-trometamol and tramadol in acute lumbago].
Metscher, B, Kübler, U, Jahnel-Kracht, H
Fortschritte der Medizin. Originalien. 2001;(4):147-51
Abstract
UNLABELLED BACKGROUND, METHOD The analgesic efficacy and tolerability of dexketoprofen-trometamol (DKPT) was compared with tramadolhydrochloride (TRAM) in a multicentre, randomised, double-blind, clinical trial in 192 Patients with acute low back pain. The initial pain at rest and on movement should be at least 50 mm on a 100 mm visual analogue scale. The daily dose during the 7 days' treatment was 50 mg TRAM t.i.d. (n = 95) or 25 mg DKPT t.i.d. (n = 97). The patients were allowed to take additional Paracetamol up to 4 x 500 mg per day as rescue medication. RESULTS From the 4th day of treatment pain on movement decreased significantly (p = 0.044) in the DKPT-group in comparison with the TRAM-group. The nocturnal pain decreased during the treatments with a difference in therapies of 22.9% in favour of DKPT. Within the DKPT-group the patients required additional Paracetamol more often only during the 1st day of treatment whereas the patients of the TRAM-group required the additional rescue medication mainly during the first 3 days of treatment. This difference was statistically significant (p = 0.011). Under DKPT treatment patients experienced significantly less adverse events (with an at least "possible" causal relationship; p = 0.026). This can be explained by central nervous disturbances that occurred only in the TRAM group. The distribution of gastro-intestinal disorders was identical in both treatment groups. CONCLUSION With this results DKPT in comparison with TRAM also showed to be a strong analgesic drug with a better risk-benefit relation due to its better tolerability.