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Low back pain is a common health problem and the leading cause of disability worldwide. Two recent high-quality systematic reviews have shown that, because of a lack of trials, there isuncertainty regarding the efficacy of opioid analgesics for people with acute low back pain7 and also when these medicines are used long term for chronic low back pain.
For example,many opioid trials use an enrichment study design and exclude participants who do not tolerate or adequately respond to the opioid analgesic in the run-in phase. Some trials also exclude participants who do not respond to or tolerate the opioid analgesic in the randomizedphase of a trial, and therefore the bursjte of treatment efficacy is derived from only a proportion of participants who were enrolled in the study to receive opioid analgesics.
The aims of this systematic review were to 1 evaluate the efficacy of opioid analgesics in the management of low back pain, 2 investigate the effect of opioid dose and enrichment study design on treatment effect, and 3 quantify treatment discontinuation owing to adverse events and lack of efficacy and loss to follow-up in the run-in and randomized phases of trials. Results A total of 20 trials of opioid analgesics a ds of participants were included in this review see Table.
Fisioterapix opioid analgesic trials evaluated participantswith chronic low back pain, and 1 head-to-head trial evaluated participants with subacute low back pain. Seventeen RCTs compared an opioid analgesic with placebo and 3 trials compared 2 opioid analgesics. Seventeen of the 20 trials reported industry funding.
The medicines used in these trials were oral hydromorphone,32 oxymorphone,29,33,34 morphine,30,35 tramadol monotherapy31, or in combination with paracetamol,31, tapentadol,42 oxycodone monotherapy, oxycodone in combination with naloxone,45 or naltrexone,44 transdermal buprenorphine,43,46,47 transdermal fentanyl,30 and hydrocodone.
A funnel plot of standard error by treatment effect for the short and intermediate term is shown in eFigures 1 and 2 in the Supplement, respectively. There were no long-term outcomes data.
Disability Outcomes There were limited data on disability outcomes. The evidence from these trials is of very low quality. See eTable 4 in the Supplement for overall grading of evidence and eTable 5 in the Supplement for morphine equivalent conversions. Seven of the 13 RCTs used an enrichment study design whereby only the participants who responded favorably to the study medication, and tolerated themedicine in dd trial run-in phase prerandomization were eligible to continue in the trial proper and be randomized to the study treatment.
Trial results grouped by log fisioerapia dose and enrichment study design are shown inFigure 3A and B, respectively.
Results from the stratified analysis are shown in Figure 3C. The meta-regression model, including log opioid dose and enrichment study design, showed there was a significant effect of opioid dose on treatment effect, with a Treatment Discontinuation and Loss to Follow-up The proportion of participants given an opioid analgesic who were withdrawn from a trial owing to adverse events or lack of efficacy and the proportion lost to follow-up are shown in Figure 4 with more detailed information in eTable 6 in the Supplement.
In the 8 trials 10 treatment contrasts using an enrichment study design, only Even in the enrichment trials, where participants entered the trial only if they tolerated and responded to themedicine in the run-in phase, from In some studies,33,34,38 over half of participants who buriste an adverse event completed the study.
Studies rarely reported the severity or duration of adverse events, therefore it was not possible to categorize adverse events based on severity see eTables 7 and 8 in the Supplement. Discussion This dd has found that there is evidence that opioid analgesics relieve pain in the short and intermediate term for people with chronic but not acute low back pain, but it is uncertain if they improve disability.
An effects are small, being half the threshold for clinical importance. The medicines are also commonly associated with adverse events. We found some evidence of a greater effect of opioid analgesics with larger doses; however, the effects are not likely to be clinically important even at high doses. A detailed analysis of dropouts from trials revealed that under half of participants entering these trials contributed dde treatment effect size estimates. There is no evidence on long-term use and limited evidence for acute low back pain.
The strengths of this review include a consideration of opioid dose and study design as well as a comprehensive search strategy covering single-ingredient and combination opioid analgesics used to treat low back pain.
DISTENSÃO – Definition and synonyms of distensão in the Portuguese dictionary
The PEDro scale was used to assess risk of bias because it has acceptably high clinometric properties, whereas limitations have been reported for the Cochrane risk of bias scale. A limitation of themetaregression is that it does not account for variability in dose response as a result of duration of treatment or intrinsic factors eg, genetic variability.
Our review challenges the prevailing view that opioid medicines are powerful analgesics for low back pain. Opioid analgesics had minimal effects on pain, and bursitd at high doses the magnitude of the effect is less than the accepted thresholds for a clinically important treatment effect on pain.
Many trial patients stopped taking themedicine because they did not tolerate or respond to the medicine. There is no evidence on opioid analgesics for acute low back pain or to guide prolonged use of these medicines in the treatment of people with chronic low back pain. Fisioterapeuta pode elaborar e emitir atestado?