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Intravenous lidocaine does not provide additional pain reduction beyond placebo in probable nociplastic chronic low back pain

In a randomized equivalence trial, 84 adults with probable nociplastic chronic non-specific low back pain received either intravenous lidocaine or saline placebo, both alongside multimodal pain management. At 3 months, the between-group difference in VAS pain was 0.24 (90% CI -0.33 to 0.81), within the prespecified equivalence margin of ±1.5, confirming therapeutic equivalence. Lidocaine did not improve pain but did improve sleep quality (mean difference in change score 1.81; 95% CI 0.49-3.14; p=0.027).

Last updated: Aug 8, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Intravenous Lidocaine Does Not Provide Additional Pain Reduction Beyond Placebo in Probable Nociplastic Chronic Low Back Pain: A Randomized Controlled Equivalence Trial.

observational

Pahari S, Hazra S, Das PP · Pain medicine (Malden, Mass.) (2026)

Participants: N/A
Duration: 4 weeks of treatment, with follow-up to 3 months
Intervention: Repeated intravenous lidocaine (1 mg/kg bolus followed by 4 mg/kg infusion weekly for 4 weeks) versus placebo saline infusion, both with background multimodal pain management (amitriptyline and aerobic exercise)
Outcome: Pain intensity (VAS) at 3 months; secondary outcomes included sleep quality (PSQI) and functional disability (QBPDS)
Effect Size: Between-group VAS difference 0.24 (90% CI -0.33 to 0.81); sleep quality mean difference 1.81 (95% CI 0.49-3.14)
Population: Adults with chronic non-specific low back pain with probable nociplastic pain features

Result:

PubMed: 42548132DOI: 10.1093/pm/pnag093

Mechanism Graph

Lidocaine is a sodium channel blocker that may modulate neuronal hyperexcitability
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In nociplastic pain, central sensitization may involve altered sodium channel activity
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Repeated infusions could potentially reduce central sensitization
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However, no additional analgesic benefit over placebo was observed

Limitations

  • ⚠Single-center trial with relatively small sample size (n=84)
  • ⚠Equivalence margin of ±1.5 VAS units may be debated as clinically meaningful
  • ⚠Background multimodal therapy may have masked or diluted any lidocaine-specific effect
  • ⚠Probable nociplastic pain classification may not be precise

Frequently Asked Questions

Does intravenous lidocaine reduce pain in chronic low back pain?▼

No, this trial found no additional pain reduction beyond placebo in patients with probable nociplastic chronic low back pain.

What was the effect of lidocaine on sleep quality?▼

Lidocaine significantly improved sleep quality compared to placebo, with a mean difference in change score of 1.81 points on the PSQI.

What is the equivalence margin used in this trial?▼

The prespecified equivalence margin was ±1.5 VAS units, and the observed difference was well within this range.

Were there any safety concerns with lidocaine infusions?▼

Adverse events were more common in the lidocaine group but were mild, transient, and self-limiting.

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References

  1. 1.Pahari S, Hazra S, Das PP. "Intravenous Lidocaine Does Not Provide Additional Pain Reduction Beyond Placebo in Probable Nociplastic Chronic Low Back Pain: A Randomized Controlled Equivalence Trial.." Pain medicine (Malden, Mass.), 2026. PMID: 42548132 DOI: 10.1093/pm/pnag093
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.