放散式冲击波与药物改善腰椎术后腰痛疗效的前瞻性随机对照研究

Radial extracorporeal shockwave therapy for postoperative low back pain compared to standard pain medications:a prospective randomized controlled trial

目的比较放散式冲击波治疗(ESWT)与传统药物治疗行经椎间孔腰椎椎体间融合术(TLIF)术后3个月腰痛的疗效。方法前瞻性单中心单盲随机对照研究。自2014年1月至2015年12月,对90例单节段腰椎间盘突出症(LDH)行开放TLIF术后3个月腰痛患者,随机分为ESWT组(每周1次×3周)和药物治疗组(洛索洛芬钠+盐酸乙哌立松)各45例,两组同时辅助康复训练治疗。观察终点是两组开始治疗后3个月。退出标准是出现腰痛加重、药物治疗不耐受等不良事件或其间需要治疗其它疾病。通过比较两组患者接受治疗1周、2周、3个月后的疼痛视觉模拟评分(VAS)和Oswestry功能障碍指数(ODI)进行组间疗效评价;通过比较ESWT组内患者每次治疗后的VAS评分和ODI评分,评价疗效与治疗次数的相关性。通过多元线性回归模型分析ESWT治疗3个月后VAS评分、ODI评分的影响因素。结果 ESWT组6例和药物治疗组4例患者符合退出标准或失访退出研究。两组患者一般资料、治疗前VAS和ODI差异无统计学意义。比较组间治疗后VAS结果:1周后ESWT组大于药物治疗组[(6.6±1.7)分比(6.4±1.3)分,P>0.05],差异无统计学意义;2周后ESWT组小于药物治疗组[(5.7±1.8)分比(6.0±1.7)分,P>0.05]差异无统计学意义;3个月后ESWT组小于药物治疗组[(2.7±2.0)分比(4.8±2.1)分,P<0.01],差异有统计学意义。比较组间治疗后ODI结果:1周后ESWT组大于药物治疗组[(38.7±6.3)%比(38.5±6.2)%,P>0.05],差异无统计学意义;2周后ESWT组小于药物治疗组[(30.3±6.9)%比(34.5±8.2)%,P<0.05],差异有统计学意义;3个月后ESWT组小于药物治疗组(14.7±8.4)%比(27.4±11.8)%,P<0.01],差异有统计学意义。比较ESWT组内治疗结果:随治疗次数增加,VAS评分减少[(6.6±1.7)分比(5.7±1.8)分比(2.7±2.0)分],ODI评分减少[(38.7±6.3)%比(30.3±6.9)%比(14.7±8.4)%],其中后2次治疗后的评分差异有统计学意义(P<0.008)。多元线性回归分析发现治疗3个月后VAS与治疗前VAS正相关(■=0.465,t=3.330,P=0.002);治疗3个月后ODI与患者年龄正相关(■=0.619,t=6.104,P<0.001),与患者体重指数(BMI)呈负相关(■=-0.277,t=-2.753,P=0.009),具有统计学意义(P<0.05)。结论对于单节段腰椎间盘突出症行TLIF术后3个月腰痛患者,ESWT的近期疗效优于药物治疗;ESWT对术后腰痛的疗效具有累积效应,随治疗次数增多而提高;患者的年龄、BMI和治疗前的疼痛水平,在一定程度上影响ESWT的疗效。

[Abstract] Objectives To evaluate the clinical outcome of radial extracorporeal shockwave therapy （ESWT） and standard pain medications for patients suffering residual low back pain （LBP） at 3 months after transforaminal lumbar interbody fusion （TLIF） surgery. Methods As a prospective, single-center, random- ized control trial from January 2014 to December 2015, 90 consecutive patients with LBP at 3 months post-TLIF due to lumbar disk herniation （LDH） were randomly assigned into 2 groups, treated by rehabilitation plus either Eswr （ once a week × 3 weeks） or pain medications （ loxoprofen sodium ＋ eperisone hydroehloride, p. o. ）. Pri- mary end point was at 3 months after the therapy and the secondary end point was any complication needed alter- native treatments i.g. deterioration of LBP, therapy intolerance, etc. The inter-group （ ESWT vs medication） and intra-group （ESWT group） were evaluated at 1 week, 2 weeks and 3 months after therapy respectively. Further- more, the influencing factors were analyzed according to the multiple linear regression models. Results Six pa- tients in ESWT group and 4 patients in medication group were failed to complete the study. There were no signifi- cant differences of the characteristics between 2 groups. Comparison of inter-group （ ESWT vs medication） VAS score：6.6 ±1.7 vs 6.4 ±1.3 at 1 week（P 〉0.05） ; 5.7 ±1.8 vs 6.0 ±1.7 at 2 weeks （P 〉0.05） ; 2.7±2.0 vs 4.8±2. 1 at 3 months （P 〈 0.01 ）. Comparison of inter-group ODI （ ESWT vs medication） ： （ 38.7 ±6.3 ） % vs （38.5±6.2）% at 1 week（P〉0.05）; （30.3±6.9）% vs （34.5 ±8.2）% at 2 weeks（P〈0.05） ; （14.7±8.4） % vs （ 27.4±11.8 ） % at 3 months （ P 〈 0.01 ）. Comparison of intra-group with the increased times of ESWT courses （ 1 vs 2 vs 3 times of ESWT） ： VAS score 6.6±1.7 vs 5.7 ± 1.8 vs 2.7±2.0, ODI （38.7±6. 3） % vs （30.3±6.9） % vs （ 14.7±8.4） %, in which there was significant differences between the latter 2 courses （P 〈 0.008）. According to the multiple linear regression results, post-ESWT VAS was positively correlated with the initial pre-ESWT VAS of patient （β= 0.465,t = 3. 330, P = 0.002） ; POst-ESWT ODI was positively correlated with age of patient（β = 0. 619, t = 6. 104, P 〈 0.001 ）, and negatively correlated with BMI of patient （β= - 0. 277,t = - 2.753,P = 0. 009）, respectively. Conclusions The early outcome of radial ESWT is superi- or to standard pain medications for LBP at 3 months post-TLIF due to LDH. The clinical efficacy improves with an accumulative manner and correlated with age, BMI and initial VAS of patients.