Zhu Jun-Yu, Yan Jun, Xiao Jian, Jia Hai-Guang, Liang Hao-Jun, Xing Geng-Yan
Orthopedic Department, The Third Medical Center of Chinese People's Liberation Army General Hospital, The Armed Police Clinical College, Anhui Medical University, Hefei 230022, Anhui Province, China.
Orthopedic Department, The Third Medical Center of Chinese People's Liberation Army General Hospital, Beijing 100039, China.
World J Clin Cases. 2023 Mar 26;11(9):1974-1984. doi: 10.12998/wjcc.v11.i9.1974.
Celecoxib has been used to treat hip discomfort and functional difficulties associated with osteonecrosis of the femoral head (ONFH), although significant adverse reactions often follow long-term use. Extracorporeal shock wave therapy (ESWT) can delay the progression of ONFH, alleviate the pain and functional limitations it causes, and avoid the adverse effects of celecoxib.
To investigate the effects of individual ESWT, a treatment alternative to the use of celecoxib, in alleviating pain and dysfunction caused by ONFH.
This was a randomized, controlled, double-blinded, non-inferiority trial. We examined 80 patients for eligibility in this study; 8 patients were excluded based on inclusion and exclusion criteria. A total of 72 subjects with ONFH were randomly assigned to group A ( = 36; celecoxib + alendronate + sham-placebo shock wave) or group B ( = 36; individual focused shock wave [ESWT based on magnetic resonance imaging three-dimensional (MRI-3D) reconstruction] + alendronate). The outcomes were assessed at baseline, at the end of treatment, and at an 8-wk follow-up. The primary outcome measure was treatment efficiency after 2 wk of intervention using the Harris hip score (HHS) (improvement of 10 points or more from the baseline was deemed sufficient). Secondary outcome measures were post-treatment HHS, visual analog scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.
After treatment, the pain treatment efficiency of group B was greater than that of group A (69% 51%; 95%CI: 4.56% to 40.56%), with non-inferiority thresholds of -4.56% and -10%, respectively. Furthermore, the HHS, WOMAC, and VAS scores in group B dramatically improved during the follow-up period as compared to those in group A ( < 0.001). After therapy, the VAS and WOMAC in group A were significantly improved from the 2 to 8 wk ( < 0.001), although HHS was only significantly altered at the 2 wk point ( < 0.001). On the 1 d and 2 wk after treatment, HHS and VAS scores were different between groups, with the difference in HHS lasting until week 4. Neither group had severe complications such as skin ulcer infection or lower limb motor-sensory disturbance.
Individual shock wave therapy (ESWT) based on MRI-3D reconstruction was not inferior to celecoxib in managing hip pain and restrictions associated with ONFH.
塞来昔布已被用于治疗与股骨头坏死（ONFH）相关的髋部不适和功能障碍，尽管长期使用往往会伴随显著的不良反应。体外冲击波疗法（ESWT）可以延缓ONFH的进展，减轻其引起的疼痛和功能限制，并避免塞来昔布的不良反应。
研究个体化ESWT（一种替代塞来昔布使用的治疗方法）在减轻ONFH引起的疼痛和功能障碍方面的效果。
这是一项随机、对照、双盲、非劣效性试验。我们检查了80例患者是否符合本研究的入选标准；根据纳入和排除标准排除了8例患者。总共72例ONFH患者被随机分为A组（n = 36；塞来昔布+阿仑膦酸钠+假安慰剂冲击波）或B组（n = 36；个体化聚焦冲击波[基于磁共振成像三维（MRI-3D）重建的ESWT]+阿仑膦酸钠）。在基线、治疗结束时和8周随访时评估结果。主要结局指标是使用Harris髋关节评分（HHS）在干预2周后的治疗效率（与基线相比提高10分或更多被认为是足够的）。次要结局指标是治疗后的HHS、视觉模拟量表（VAS）和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分。
治疗后，B组的疼痛治疗效率高于A组（69%对51%；95%CI：4.56%至40.56%），非劣效性阈值分别为-4.56%和-10%。此外，与A组相比，B组在随访期间的HHS、WOMAC和VAS评分显著改善（P < 0.001）。治疗后，A组的VAS和WOMAC在第2至8周时显著改善（P < 0.001），尽管HHS仅在第2周时显著改变（P < 0.001）。在治疗后1天和2周时，两组之间的HHS和VAS评分存在差异，HHS的差异持续到第4周。两组均未出现皮肤溃疡感染或下肢运动感觉障碍等严重并发症。
基于MRI-3D重建的个体化冲击波疗法（ESWT）在治疗与ONFH相关的髋部疼痛和功能受限方面不劣于塞来昔布。
