Cochrane Clinical Answers - Fulltext - What are the effects of paracetamol in people with acute low back pain?

Question:What are the effects of paracetamol in people with acute low back pain?

Clinical Answer:

High-quality evidence (from a single very large, trial) assessing paracetamol compared with placebo in people with acute low back pain suggested that paracetamol had little or no effect on pain, function and disability in this population. Even if an effect had been found, the clinical relevance of comparing paracetamol with placebo in this population is questionable, as in routine clinical practice, patients with acute low back pain would likely be offered an NSAID as first treatment. An analysis of use of paracetamol in patients with risk factors for use of NSAIDs, for example those with co-morbidities (e.g. coronary artery disease, peptic ulcer, history of gastrointestinal bleeding, chronic kidney disease, or diabetes) or those using anticoagulants would potentially provide a more clinically useful analysis in helping healthcare providers make decisions regarding pharmacotherapy in patients with acute low back pain.

Full outcome data is detailed below:

1.Paracetamol versus placebo

  • Population, Intervention, Comparator

    Population:

    Adults with acute low back pain (defined as pain between the 12th rib and buttock crease < 6 weeks' duration and preceded by 1 month of no pain), with or without leg pain, and pain of at least of moderate-intensity (measured by an adaptation of item 7 of the SF-36) recruited from family care

    Intervention:

    Two intervention groups: ‘time-contingent’ group; paracetamol tablets 4 g per day given in three divided doses; 'as required' group; up to 4 g paracetamol tablets per day. Both groups were asked to take the paracetamol until recovery or up to a maximum of 4 weeks

    Comparator:

    Placebo

  • OUTCOME 1.1: Pain

    Narrative result:

    Pain was assessed with a numeric rating scale from 0 to 100. No statistically significant difference between groups was seen at any time point. Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.1.1: Pain - [subgroup: 1 week (immediate-term)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1520 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 1.49, 95% CI -1.30 to 4.28).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.1.2: Pain - [subgroup: 2 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1505 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 1.00, 95% CI -1.70 to 3.70).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.1.3: Pain - [subgroup: 4 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1516 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.49, 95% CI -1.99 to 2.97).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.1.4: Pain - [subgroup: 12 weeks (short-term)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1526 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.50, 95% CI -2.92 to 1.92).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
  • OUTCOME 1.2: Disability

    Narrative result:

    Disability was assessed with the Roland Morris Disability Questionnaire (from 0 to 24 points). No statistically significant difference between groups was seen at any time point. Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.2.1: Disability - [subgroup: 1 week (immediate-term)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1511 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.45, 95% CI -1.15 to 0.25).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.2.2: Disability - [subgroup: 2 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1501 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.00, 95% CI -0.65 to 0.65).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.2.3: Disability - [subgroup: 4 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1506 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.05, 95% CI -0.50 to 0.60).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.2.4: Disability - [subgroup: 12 weeks (short-term)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1522 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.10, 95% CI -0.39 to 0.59).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
  • OUTCOME 1.3: Function

    Narrative result:

    Disability was assessed using the Patient-Specific Functional Scale from 0 to 10. No statistically significant difference between groups was seen at any time point. Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.3.1: Function - [subgroup: 1 week (immediate-term)]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1511 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.05, 95% CI -0.32 to 0.22).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.3.2: Function - [subgroup: 2 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1499 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.15, 95% CI -0.42 to 0.12).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.3.3: Function - [subgroup: 4 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1502 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.05, 95% CI -0.31 to 0.21).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.3.4: Function - [subgroup: 12 weeks (short-term)]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1518 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.00, 95% CI -0.23 to 0.23).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
  • OUTCOME 1.4: Quality of life, physical component

    Narrative result:

    Quality of life was measured with the 12-Item Short Form Health Survey (SF-12). No statistically significant difference between groups was seen at any time point. Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.4.1: Quality of life, physical component - [subgroup: 4 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1145 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.79, 95% CI -1.94 to 0.36).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.4.2: Quality of life, physical component - [subgroup: 12 weeks (short-term)]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 760 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference 0.41, 95% CI -0.91 to 1.72).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
  • OUTCOME 1.5: Quality of life, mental component

    Narrative result:

    Quality of life was measured with the 12-Item Short Form Health Survey (SF-12). A difference in quality of life favoring paracetamol was seen at 12 weeks. Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.5.1: Quality of life, mental component - [subgroup: 4 weeks]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 1145 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (mean difference -0.60, 95% CI -1.38 to 0.17).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.5.2: Quality of life, mental component - [subgroup: 12 weeks (short-term)]
      Risk of bias of studies:

      The study reported adequate allocation concealment and random sequence generation, adequate blinding of participants/carers/outcome assessors and had low numbers of withdrawals.

      Narrative result:

      One RCT with 760 participants found that people on paracetamol had better quality of life (mental component) compared with placebo.

      Relative effect or mean difference:

      There was a statistically significant difference between groups, in favor of paracetamol (mean difference 0.90, 95% CI 0.08 to 1.72).

      Forest plot from Cochrane Review

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
  • OUTCOME 1.6: Adverse effects

    Narrative result:

    There was no evidence of a difference between groups for any adverse effect or serious adverse effects (as defined by each study). Click below for full details.

    Reference:
    Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.6.1: Adverse effects - [subgroup: Any adverse effects (up to 12 weeks)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1624 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (RR 1.07, 95% CI 0.86 to 1.33).

      Forest plot from Cochrane Review

      Absolute effect:

      115 per 1000 people (95% CI 92 to 142) with paracetamol compared with 107 per 1000 people with placebo.

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]
    • Subgroup analysis 1.6.2: Adverse effects - [subgroup: Serious adverse effects (up to 12 weeks)]
      Quality of the evidence:

      The reviewers performed a GRADE assessment of the quality of evidence for this outcome at this time point and stated that the evidence was high quality. See Summary of findings from Cochrane review

      Narrative result:

      One RCT with 1643 participants found no statistically significant difference between groups.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (RR 0.90, 95% CI 0.30 to 2.67).

      Forest plot from Cochrane Review

      Absolute effect:

      91 per 1000 people (95% CI 90 to 93) with paracetamol compared with 90 per 1000 people with placebo.

      Reference:
      Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]

Additional Information:

DOI

10.1002/cca.1482

Publication Dates

  1. Published Online: 19 DEC 2016

CCA derived from

Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database of Systematic Reviews 2016, Issue 6. Art. No.: CD012230. DOI: 10.1002/14651858.CD012230. [Review search date: August 2015]

How to Cite

What are the effects of paracetamol in people with acute low back pain? Karen Pettersen and David S. Edwards (on behalf of Cochrane Clinical Answers Editors). Cochrane Clinical Answers 2016. DOI: 10.1002/cca.1482.

Further Information

  • CCA Associate editor: Karen Pettersen, Editor, Cochrane Clinical Answers, John Wiley & Sons Ltd., Chichester, SXW, UK.
  • CCA Associate editor: David S. Edwards, Assistant Professor, Department of Family & Community Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
  • CCA Editor: Karen Pettersen. Correspondence to kpettersen@wiley.com.