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Analgesics have no effect on functional outcome in CLBP patients
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June 2014
Analgesics have no effect on functional outcome in CLBP patients
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT
Eur Spine J. 2014 Apr;23(4):800-6Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
50 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.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
Stichting Beatrixoord, The Netherlands.
Conflicts:
None disclosed
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?
Study Characteristics
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Population:
50 patients, aged 18 years or older, suffering from chronic low back pain for a duration greater than 3 months, and with a VAS evaluation for worst pain in the past week of at least 4.0 cm.
Intervention:
Analgesic Group: Patients were administered acetaminophen/tramadol 325mg/37.5mg per capsule. Medication was titrated from one capsule twice daily up to a maximum of two capsules, three times daily (1,950mg acetaminophen and 225mg tramadol). The titration phase was 1 week in duration, followed by 1 week on a steady dose. (n=25; 3 did not complete the study; Mean Age: 42.0 years; M/F=7/18)
Comparison:
Placebo Group: Patients were administered equivalent quantities of placebo. Medication was titrated from one capsule twice daily up to a maximum of two capsules, three times daily. The titration phase was 1 week in duration, followed by 1 week on a steady dose.(n=25; 1 did not complete the study; Mean Age: 44.0 years; M/F=9/16)
Outcomes:
Patient functional capacity was evaluated using FCE (Functional capacity evaluation) subtests which included lifting, carrying, static bending, and dynamic bending. Self-reported disability was assessed using the Roland Morris Disability Questionnaire (RMDQ, 24 items; higher scores indicate more disability). Additionally, patients’ global pain change was assessed by reporting: worsened pain, same pain, some relief, or complete relief. Note that patients who had initially exhibited global (some or complete) pain relief were considered responders.
Methods:
RCT: Single-Centered: Triple-Blinded (Surgeons; Assessors; and Patients)
Time:
Patients were assessed over 2 weeks.
What were the important findings?
- 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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