Analgesics have no effect on functional outcome in CLBP patients .
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(11):36 Eur Spine J. 2014 Apr;23(4):800-650 patients suffering from chronic low back pain were randomized to investigate the effect of acetaminophen and tramadol in achieving favorable outcomes of function, self-reported disability, and pain relief in patients, when compared to a placebo administered over 2 weeks. The evidence presented in this study suggested that the use of acetaminophen and tramadol did not produce significant improvements in functional capacity or self-reported disability when compared to placebo in chronic low back pain patients. Further analysis pertaining to responders observed improved functioning as a result of treatment with analgesics, and responders reported lower catastrophizing scores.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
2/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Sensitization following low back pain (LBP) contributes to chronic pain in the absence of tissue damage, and may result in functional disability. Non-specific LBP is frequently treated with analgesics such as acetaminophens, NSAIDs, tramadol, and opioids, in order to manage pain and restore function. The relationship between pain intensity and functional capacity remains controversial and this study was therefore needed to investigate the effect of a combination of analgesics on functional capacity and disability in chronic low back pain patients (CLBP).
What was the principal research question?
Is a combination of acetaminophen and tramadol over 2 weeks effective in achieving favorable outcomes of function, self-reported disability, and pain relief in patients suffering from CLPB?
- Primary outcome assessments of functional capacity (lifting, carrying, static bending, and dynamic bending) indicated no significant differences between placebo and analgesic groups (all p>0.05).
- 10 (42%) responders reported some or complete pain relief compared to 1 patient in the placebo group (p=0.005).
- Responders indicated a tendency to improve on lifting performance (p=0.10) with a significant reduction of RMDQ (From 12.0 to 10.5; p=0.02).
- Responders demonstrated a significantly lower score on subscale catastrophizing of the PCL (median 35.5 vs. 44.0 in non-responders; p=0.005). No other differences between responders and non-responders were noted.
What should I remember most?
The use of acetaminophen and tramadol did not produce significant improvements in functional capacity of self-reported disability when compared to placebo in chronic low back pain patients. Note that a subgroup analysis suggested improved functioning as a result of treatment with analgesics, and responders reported lower catastrophizing scores.
How will this affect the care of my patients?
The evidence presented in this study demonstrated that analgesic treatment with acetaminophen and tramadol did not significantly affect functional outcome in patients suffering from low back. Large scale studies with longer follow-up periods are needed to investigate this relationship further.
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