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

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.

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Publication Details

Journal
Scientific Reports
Published
2025-12-09
DOI
https://doi.org/10.1038/s41598-025-31094-y
Primary Topic
Inflammatory mediators and NSAID effects
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Kazuhiro Hayashi, Hiroshi Ueno, Young-Chang Park Arai, Yukiko Shiro et al.
Scientific Reports
Inflammatory mediators and NSAID effects
article

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

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

Abstract

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.

Scientific ReportsVol. 16(1)
Fukushima Medical University (JP), University of Tsukuba (JP), Chiba University (JP), Aichi Medical University (JP), Kyoto University (JP), Kobe Gakuin University (JP), Nagoya Gakuin University (JP), Fukuoka Hospital (JP), Japan Association for Development of Community Medicine (JP), Osakakita Teishin Hospital (JP), Osaka Yukioka Medical University (JP), Matsushita Memorial Hospital (JP), Dokkyo Medical University (JP), Bukkyo University (JP)
Openalex Percentile: Top 58%
Inflammatory mediators and NSAID effects
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