PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial

Mathieson, Stephanie; Maher, Christopher G.; McLachlan, Andrew J.; Latimer, Jane; Koes, Bart W.; Hancock, Mark J.; Harris, Ian; Day, Richard O.; Pik, Justin; Jan, Stephen; Billot, Laurent; Lin, Chung‐Wei Christine

doi:10.1186/1745-6215-14-213

Cited by 24 publications

(17 citation statements)

References 39 publications

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“…Our review demonstrates that there is limited evidence on the use of gabapentinoids in nonspecific CLBP, and the existing evidence in the form of RCTs does not support their use. It is possible that ongoing or unpublished studies [ 50 , 51 ] may more definitively inform us on this issue, although one such study specific to CLBP was withdrawn prior to enrollment [ 52 ].…”

Section: Discussionmentioning

confidence: 99%

Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials

et al. 2017

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Background and objectiveChronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse. We aimed to assess the effectiveness and safety of gabapentinoids in adult CLBP patients.MethodsElectronic databases of MEDLINE, EMBASE, and Cochrane were searched from their inception until December 20th, 2016. We included randomized control trials reporting the use of gabapentinoids for the treatment of CLBP of >3 months duration, in adult patients. Study selection and data extraction was performed independently by paired reviewers. Outcomes were guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief and safety as the primary outcomes. Meta-analyses were performed for outcomes reported in 3 or more studies. Outcomes were reported as mean differences (MDs) or risk ratios (RRs) with their corresponding 95% confidence intervals (CIs), and I2 in percentage representing the percentage variability in effect estimates that could be explained by heterogeneity. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of evidence.ResultsOut of 1,385 citations, eight studies were included. Based on the interventions and comparators, studies were analyzed in 3 different groups. GB compared with placebo (3 studies, n = 185) showed minimal improvement of pain (MD = 0.22 units, 95% CI [−0.5 to 0.07] I2 = 0%; GRADE: very low). Three studies compared PG with other types of analgesic medication (n = 332) and showed greater improvement in the other analgesic group (MD = 0.42 units, 95% CI [0.20 to 0.64] I2 = 0; GRADE: very low). Studies using PG as an adjuvant (n = 423) were not pooled due to heterogeneity, but the largest of them showed no benefit of adding PG to tapentadol. There were no deaths or hospitalizations reported. Compared with placebo, the following adverse events were more commonly reported with GB: dizziness-(RR = 1.99, 95% CI [1.17 to 3.37], I2 = 49); fatigue (RR = 1.85, 95% CI [1.12 to 3.05], I2 = 0); difficulties with mentation (RR = 3.34, 95% CI [1.54 to 7.25], I2 = 0); and visual disturbances (RR = 5.72, 95% CI [1.94 to 16.91], I2 = 0). The number needed to harm with 95% CI for dizziness, fatigue, difficulties with mentation, and visual disturbances were 7 (4 to 30), 8 (4 to 44), 6 (4 to 15), and 6 (4 to 13) respectively. The GRADE evidence quality was noted to be very low for dizziness and fatigue, low for difficulties with mentation, and moderate for visual disturbances. Functional and emotiona...

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Section: Discussionmentioning

confidence: 99%

Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials

et al. 2017

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“…Spinal disorders affect the functioning of the whole organism. They can have an effect on the metabolism of proteins, and especially on changes in the concentration of free amino acids in the blood (Mathieson et al 2013).…”

Section: Discussionmentioning

confidence: 99%

Concentration of Some Amino Acids in Blood Plasma and Study Results of Lumbosacral Bone System Computer Tomography

Wójcik¹,

Sokołowska²,

Borzęcki³

2015

hpc

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Concentration of some amino acids in blood plasma and study results of lumbosacral bone system computer tomography. Health Problems of Civilization, 3 (9), p. 5-11. Summary: Introduction and objective: Back pain are the most common ailment within the human locomotor system. Because of their prevalence, they were classified as diseases of civilization. The aim of the study was to attempt to assess the concentration of selected amino acids in plasma and correlating the results of laboratory tests with the occurrence of backaches. Material and method: The study group included 188 patients presenting for CT scan administering as the cause of their symptoms low back pains. All of these patients gave the blood samples from which the concentration of free amino acids was estimated by ion exchange chromatography using an automated amino acid analyzer AAA 400 from INGOS Praha. The control group consisted of patients who underwent testing using computed tomography and there were no primary or secondary changes associated with degeneration in the lumbar spine. Results: Patients on the basis of research carried out by computed tomography were divided into five groups according to disease entity. Analyzing the average concentration of essential amino acids in the blood plasma of patients of each group, it was found that it is higher in the case of lysine for each considered disease entity. The average concentration of methionine in all disease entities does not deviate from the average values in the control group. Analysis of the average concentration of selected essential amino acids revealed that in the case presented disorders underwent their level of variation. Average concentrations of selected amino acids have proven to be very similar in both groups. Slightly higher values proved to be in the control group for proline and lysine. Conclusions: The concentration of amino acids varies with the severity of degenerative changes in the connections as well as in interbody joints. The highest increase in the concentrations of all tested amino acids are present in root bands. Decrease in the concentrations of all tested amino acids appears in cancer.

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“…The trial was con-ducted in accordance with the Consolidated Standards of Reporting Trials guidelines. 19 The trial protocol 20 and statistical analysis plan 21 have been published previously and are available with the full text of this article at NEJM.org. Ethics approval for the trial was granted by the University of Sydney Human Research Ethics Committee.…”

Section: Trial Design and Oversightmentioning

confidence: 99%

Trial of Pregabalin for Acute and Chronic Sciatica

Figueiredo

Teixeira

2017

N Engl J Med

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BACKGROUND Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. METHODS We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. RESULTS A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], −0.2 to 1.2; P = 0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, −0.5 to 1.0; P = 0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group. CONCLUSIONS Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group.

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PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial

Cited by 24 publications

References 39 publications

Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials

Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials

Concentration of Some Amino Acids in Blood Plasma and Study Results of Lumbosacral Bone System Computer Tomography

Trial of Pregabalin for Acute and Chronic Sciatica

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