Xuejiao Guo1, Lin Li1,2, Zhe Yan1, Yunze Li1, Zhiyou Peng1, Yixin Yang1, Yanfeng Zhang1, Christoph Schmitz3, Zhiying Feng4. 1. Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. 2. Department of Anesthesiology, Yuyao People Hospital of Zhejiang, Ningbo, China. 3. Extracorporeal Shock Wave Research Unit, Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, Munich, Germany. 4. Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. fzy1972@zju.edu.cn.
Abstract
BACKGROUND: To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China). METHODS: 140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline. RESULTS: All scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed. CONCLUSIONS: rESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP. LEVEL OF EVIDENCE: Level I, prospective, randomized, active-controlled trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607 . LEVEL OF EVIDENCE: Level I; prospective, randomized, controlled trial.
BACKGROUND: To investigate whether respectively radial extracoporeal shock wave therapy (rESWT) or a combination of rESWT, celecoxib and eperisone (rESWT + C + E) are superior in reducing pain in patients with chronic nonspecific low back pain (cnsLBP) compared to C + E alone (a standard treatment of this condition in China). METHODS: 140 patients with cnsLBP were randomly allocated to rESWT (n = 47), rESWT + C + E (n = 45) or C + E alone (n = 48) for four weeks between November 2017 and March 2019. Outcome was evaluated using the Pain Self-Efficacy Questionnaire (PSEQ), Numerical Rating Scale (NRS), Oswestry Low Back Pain Disability Questionnaire and Patient Health Questionnaire 9, collected at baseline as well as one week (W1), W2, W3, W4 and W12 after baseline. RESULTS: All scores showed a statistically significant improvement over time. The PSEQ and NRS scores showed a significant Time × Treatment effect. Patients treated with rESWT had significantly lower mean NRS values than patients treated with rESWT + C + E at W1 and W3, as well as than patients treated with C + E alone at W3 and W4. No severe adverse events were observed. CONCLUSIONS: rESWT may not be inferior to respectively rESWT + C + E or C + E alone in reducing pain in patients with cnsLBP. LEVEL OF EVIDENCE: Level I, prospective, randomized, active-controlled trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT03337607. Registered November 09, 2017, https://www.clinicaltrials.gov/ct2/show/NCT03337607 . LEVEL OF EVIDENCE: Level I; prospective, randomized, controlled trial.
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