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目的 探索老年腰痛患者应用可穿戴设备(量子微磁波功能衣)干预的临床效果,为大规模临床试验及推广应用奠定基础.方法 前瞻性研究,于2021年11月25日至2022年3月10日在北京医院骨科门诊招募60岁及以上主诉腰痛的患者,按照入选及排除标准最终纳入40例患者,将40例老年腰痛受试者随机分为试验组20例(常规医疗干预+穿戴量子微磁波功能衣)和对照组20例(常规医疗干预),试验组患者每天24 h穿戴量子微磁波功能衣,试验持续时间3个月,采用视觉模拟量表(VAS)和Oswestry功能障碍指数(ODI)评分以及腰椎核磁共振检查结果进行治疗效果的评估,比较试验组和对照组治疗前后组内及组间的差异.结果 对照组1例因个人原因退出试验,39例受试者完成了临床试验.试验组和对照组首诊和复诊时VAS及ODI评分比较结果显示,试验组VAS及ODI评分下降较为明显,即VAS评分变化量[△VAS评分(复诊-首诊)]、ODI评分变化量[△ODI评分(复诊-首诊)]两组比较差异均具有统计学意义(Z=-3.787、-3.884,均P＜0.001);腰椎核磁共振显示腰椎周围软组织炎症,对照组软组织炎症无明显变化13例(86.7％)、好转2例(13.3％);试验组无明显变化5例(31.3％)、好转11例(68.7％),试验组腰椎周围软组织炎症好转显著优于对照组(x2=9.764、P=0.002).结论 在常规医疗干预的基础上,3个月持续穿戴量子微磁波功能衣可以进一步有效缓解老年人腰痛.

Objective To investigate the clinical impact of wearable devices,specifically quantum micro wave functional clothing,on elderly patients experiencing low back pain.Methods This prospective cohort study recruited patients aged 60 and above who visited the Orthopedics Clinic of Beijing Hospital between November 25,2021,and March 10,2022,and presented with complaints of low back pain.Following the specified inclusion and exclusion criteria,a total of 40 patients were ultimately included in the study.These forty elderly patients with low back pain were randomly assigned to either an intervention group consisting of 20 cases(receiving conventional medical intervention along with wearing quantum micromagnetic wave functional clothing)or a control group of 20 cases(receiving only conventional medical intervention).Patients in the intervention group wore the quantum microwave functional clothing continuously for 24 hours a day throughout the 3-month study duration.The treatment effect was assessed using the visual analog scale(VAS),Oswestry disability index(ODI)scores,and lumbar spine MRI examination results.Intra-group and inter-group differences between patients in the intervention group and the control group were compared before and after treatment.Results One patient in the control group withdrew from the study due to personal reasons,and 39 patients completed the clinical study.The comparison results of the VAS and ODI scores between the intervention and control groups at the initial and follow-up visits indicated a significant decrease in both VAS and ODI scores in the intervention group.The differences in the change of VAS scores(△VAS score)and ODI scores(△ODI score)between the two groups were statistically significant(Z=-3.787,-3.884,both P＜0.001).Soft tissue inflammation around the lumbar spine was assessed through lumbar spine MRI examination.Results revealed that in the control group,13 cases(86.7％)showed no significant change in soft tissue inflammation and 2 cases(13.3％)improved;whereas in the intervention group,5 cases(31.3％)showed no significant change and 11 cases(68.7％)improved.The improvement in soft tissue inflammation around the lumbar spine was significantly greater in the intervention group compared to the control group(x2=9.764,P=0.002).Conclusions In addition to conventional medical intervention,consistent use of quantum micromagnetic wave functional clothing for a period of 3 months has been found to effectively reduce low back pain in elderly individuals.