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<p>Pharmacological treatment is commonly used for patients with chronic low back pain (CLBP). However, very low-quality evidence exists for paracetamol as a treatment option for CLBP; therefore, recommendations are contradictory among the guidelines. This randomized controlled study aimed to compare the analgesic effects of paracetamol and celecoxib in a non-inferiority trial. This non-inferiority trial tested the hypothesis that paracetamol is as effective as celecoxib for the treatment of CLBP within a pre-specified non-inferiority margin. One hundred fifty-six patients with CLBP were considered eligible and randomly allocated to a group receiving paracetamol or celecoxib. The pain intensity was measured using a numerical rating scale as the primary outcome. Secondary outcomes were pain-related psychological variables, quality of life, and adverse events. One hundred thirty-nine patients completed the study (paracetamol, 70; celecoxib, 69). We observed that the mean differences in the NRS changes between the two medication groups from baseline to weeks two and four did not significantly exceed the non-inferiority margin. Paracetamol had a superior effect on pain-related psychological variables and quality of life compared to celecoxib. These results suggest that paracetamol provides analgesic effects comparable to celecoxib for CLBP, meeting the criteria for non-inferiority.</p>

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Randomized open-label non-inferiority trial of paracetamol or celecoxib for patients with chronic low back pain

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月9日

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  • Kazuhiro Hayashi,
  • Kenji Miki,
  • Hiroshi Ueno,
  • Miho Sekiguchi,
  • Young-Chang Arai,
  • Takuya Nikaido,
  • Yasuhiro Shiga,
  • Masayuki Inoue,
  • Hideki Kataoka,
  • Yuya Kawarai,
  • Yoshiyuki Kimura,
  • Keisuke Shimizu,
  • Kazuhiro Shimo,
  • Yukiko Shiro,
  • Katsuyoshi Tanaka,
  • So Tanaka,
  • Yoshiyuki Hirakawa,
  • Kousei Miura,
  • Masao Yukioka

摘要

Pharmacological treatment is commonly used for patients with chronic low back pain (CLBP). However, very low-quality evidence exists for paracetamol as a treatment option for CLBP; therefore, recommendations are contradictory among the guidelines. This randomized controlled study aimed to compare the analgesic effects of paracetamol and celecoxib in a non-inferiority trial. This non-inferiority trial tested the hypothesis that paracetamol is as effective as celecoxib for the treatment of CLBP within a pre-specified non-inferiority margin. One hundred fifty-six patients with CLBP were considered eligible and randomly allocated to a group receiving paracetamol or celecoxib. The pain intensity was measured using a numerical rating scale as the primary outcome. Secondary outcomes were pain-related psychological variables, quality of life, and adverse events. One hundred thirty-nine patients completed the study (paracetamol, 70; celecoxib, 69). We observed that the mean differences in the NRS changes between the two medication groups from baseline to weeks two and four did not significantly exceed the non-inferiority margin. Paracetamol had a superior effect on pain-related psychological variables and quality of life compared to celecoxib. These results suggest that paracetamol provides analgesic effects comparable to celecoxib for CLBP, meeting the criteria for non-inferiority.