Paracetamol for low back pain: the state of the research field

Figures & data

Table 1. RCTs evaluating paracetamol vs placebo in patients with acute low back pain

Author(s), year	patients	interventions	Outcomes/follow-up	Results	Remarks
Nadler 2002 [25]	Acute LBP (n = 371)	(1) heat wrap (2) ibuprofen (1200 mg/d) (3) paracetamol (4000 mg/d) (4) placebo (5) unheated back wrap All interventions for 2 days	Pain relief (NRS 0–5); Disability (RMDQ 0–24)	No data on the placebo group presented. Pain relief after 3–4 days: group 2 (1.68) group 3 (1.95) Disability after 3–4 days: group 2 (2.7) group 3 (2.9)
Williams 2014 [24]	Acute LBP (n = 1653)	(1) paracetamol regular (3990 mg/d) (2) paracetamol as needed (max 4000 mg/d) (3) placebo All interventions max 4 weeks	Pain (NRS 0–10); Disability (RMDQ 0–24)	No difference in outcome between the 3 groups. Pain intensity after 2 weeks: Group 1 (2.6) Group 2 (2.6) Group 3 (2.5) Mean disability afer 2 weeks: Group 1 (5.2) Group 2 (5.4) Group 3 (5.3)	Median days to recovery Group 1(17) Group 2 (17) Group 3 (16)
Friedman 2020 [27]	Acute LBP (n = 120)	(1) Ibuprofen (600 mg) + paracetamol(2000–4000 mg) (2) Ibuprofen (600 mg) + placebo Both interventions for 7 days	Disability (RMDQ 0–24) Pain (4-point scale)	No difference in outcome between the 2 group Pain after one week none/mild: Group 1 (72%) Group 2 (72%) Improvement disability: Group 1 (11.1) Group 2 (11.9)

Table 2. RCTs evaluating paracetamol vs NSAIDs in patients with acute or chronic low back pain

Author(s), year	patients	interventions	Outcomes/follow-up	Results	Remarks
Wiesel 1980 [34]	Acute LBP (n = 45)	(1) aspirin (625 mg – 4 times/d) (2) phenylbutazone (100 mg- 4times/d) (3) paracetamol (1 tablet (?mg) 2 times/d All intervention for 5 days	Pain; No days before return work/follow-up 2 weeks	No significant differences. Mean number of days before return work group 1 (5.7) group 2 (6.5) group 3(5.7)	(1)concerns soldiers (age 17–34) (2)phenylbutazone is taken of the market
Nadler 2002 [25]	Acute LBP (n = 371)	(1) heat wrap (2) ibuprofen (1200 mg/d) (3) paracetamol (4000 mg/d) (4) placebo (5) unheated back wrap All interventions for 2 days	Pain relief (NRS 0–5); Disability (RMDQ 0–24)/follow up 4 days	No difference (2) vs (3) regarding pain and disability Pain relief after 3–4 days: group 2 (1.68) group 3 (1.95) Disability after 3–4 days: group 2 (2.7) group 3 (2.9)
Miki 2018 [35]	Acute LBP (n = 127)	(1) loxoprofen (60 mg-3 times/d) (2) paracetamol (600 mg-4 times/d) Both intervention for 4 weeks	Pain (NRS)/follow up 4 weeks	No significant differences Mean difference I pain score Group 1 (−0.5) Group 2 (0)	High drop-out rate of 45%
Hickey 1982 [36]	Chronic LBP (n = 30)	(1) diflunisal (1000 mg/d) (2) paracetamol (4000 mg/d) Both intervention for 4 weeks	No. of patient with none/mild back pain	No difference between the groups. No. of patient with none/mild back pain after 2,4 weeks Group 1 (11,13) Group 2 (9,7)	More patients rated (1) as good or excellent (10 out of 16 vs 4 out of 12)

Table 3. Paracetamol recommendation in recent (2016 onwards) clinical guidelines for back pain

Country	Recommendation concerning paracetamol for back pain
Australia, 2016	Recommended for acute low back pain – but information is included that there is evidence that paracetamol may not be more effective than placebo
Belgium, 2017	Not recommended as single pain medication
Canada, 2017	Recommended as first choice pain medication for acute and chronic back pain. NSAIDs are second choice.
Denmark, 2018	Only after careful consideration in patients with acute low back, because of evidence of no short term effect
Germany, 2017	Not recommended due to new evidence of lack of effect compared to placebo
The Netherlands, 2017	May be prescribed regularly or as-needed; NSAIDS may not be more effective than paracetamol
UK, 2017	Not recommended
US, 2017	Not recommended due to new evidence indicating that paracetamol is not more effective than placebo

Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain. Spine (Phila Pa 1976). 2002;27(10):1012‐1017. .

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Williams CM, Maher CG, Latimer J, et al., Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial. Lancet. 384(9954): 1586‐1596. 2014. .

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Friedman BW, Irizarry E, Chertoff A, et al. Ibuprofen plus acetaminophen versus ibuprofen alone for acute low back pain: an emergency department-based randomized study. Acad Emerg Med. 2020;27(3):229‐235.

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Wiesel SW, Cuckler JM, Deluca F, et al. Acute low-back pain. An objective analysis of conservative therapy. Spine (Phila Pa 1976). 1980;5(4):324‐330.

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Miki K, Ikemoto T, Hayashi K, et al. Randomized open-label [corrected] non-inferiority trial of acetaminophen or loxoprofen for patients with acute low back pain [published correction appears in J Orthop Sci. 2019 Jan;24(1):192]. J Orthop Sci. 2018;23(3):483‐487.

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Hickey RF. Chronic low back pain: a comparison of diflunisal with paracetamol. N Z Med J. 1982;95(707):312‐314.

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