经皮体外冲击波疗法（rESWT）、rESWT 联合塞来昔布和乙哌立松（C+E）或 C+E 单独治疗慢性非特异性腰痛的疗效和安全性：一项前瞻性、随机试验。
Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial.
机构信息
Department of Pain Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Anesthesiology, Yuyao People Hospital of Zhejiang, Ningbo, China.
出版信息
J Orthop Surg Res. 2021 Dec 4;16(1):705. doi: 10.1186/s13018-021-02848-x.
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.
背景
本研究旨在比较单纯体外冲击波疗法（rESWT）、rESWT 联合塞来昔布和乙哌立松（rESWT+C+E）与 C+E 联合治疗对慢性非特异性下腰痛（cnsLBP）患者的疼痛缓解效果，以探讨 rESWT 是否优于 C+E 联合治疗（这是中国治疗该疾病的标准方法）。
方法
2017 年 11 月至 2019 年 3 月，140 例 cnsLBP 患者被随机分为 rESWT 组（n=47）、rESWT+C+E 组（n=45）和 C+E 组（n=48），分别接受为期四周的 rESWT、rESWT+C+E 或 C+E 联合治疗。采用疼痛自我效能问卷（PSEQ）、数字评分量表（NRS）、Oswestry 下腰痛残疾问卷和患者健康问卷 9 分别于基线和治疗后 1 周（W1）、2 周（W2）、3 周（W3）、4 周（W4）、12 周（W12）进行评估。
结果
所有评分均随时间显著改善。PSEQ 和 NRS 评分显示出显著的时间与治疗效果的交互作用。在 W1 和 W3 时，rESWT 组的平均 NRS 值显著低于 rESWT+C+E 组，在 W3 和 W4 时，rESWT 组的平均 NRS 值也显著低于 C+E 组。未观察到严重不良事件。
结论
rESWT 在缓解 cnsLBP 患者疼痛方面可能不劣于 rESWT+C+E 或 C+E 联合治疗。
证据水平
I 级，前瞻性、随机、活性对照试验。
试验注册
Clinicaltrials.gov 标识符：NCT03337607。注册于 2017 年 11 月 9 日，网址：https://www.clinicaltrials.gov/ct2/show/NCT03337607。
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