Lee Jee Young, Park Kyoung Sun, Kim Suna, Seo Ji Yeon, Cho Hyun-Woo, Nam Dongwoo, Park Yeoncheol, Kim Eun-Jung, Lee Yoon Jae, Ha In-Hyuk
Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
Jaseng Clinical Research Center, Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.
J Pain Res. 2022 Sep 23;15:2989-2996. doi: 10.2147/JPR.S382550. eCollection 2022.
Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservative treatment for LSS.
A multi-centered, pragmatic, parallel-group study will be conducted. In total, 98 patients will be recruited at seven institutes; recruitment began in May 2022. After two treatment sessions per week over a period of 12 weeks, follow-up assessments will be held at weeks 13, 25, and 53.
The efficacy of pharmacopuncture and conservative care will be pragmatically compared in patients radiologically diagnosed with LSS. Pain severity will be measured using the numeric rating scale and visual analog scale. Walking distance will also be evaluated. Patient-centered evaluations will include the Zurich Claudication Questionnaire, Short-Form 12 for Health-Related Quality of Life, EuroQoL 5 Dimension 5 Levels, and Patient Global Impression of Change.
The results of this study will confirm the efficacy of pharmacopuncture in comparison to conventional non-surgical treatment and will thus facilitate the prioritization of patient-centered interventions for LSS.
This study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).
腰椎管狭窄症（LSS）是一种慢性退行性疾病。考虑到受影响年龄组的风险和益处以及该疾病的特征，建议采取非手术干预。然而，迄今为止，尚无研究比较各种非手术干预措施以确定LSS合适的一线非手术治疗方法。因此，本研究的目的是评估药物注射疗法作为LSS的非手术、保守治疗方法的疗效。
将进行一项多中心、务实、平行组研究。总共将在7家机构招募98名患者；招募工作于2022年5月开始。在每周进行两次治疗，为期12周后，将在第13周、第25周和第53周进行随访评估。
将对经影像学诊断为LSS的患者，切实比较药物注射疗法和保守治疗的疗效。疼痛严重程度将使用数字评分量表和视觉模拟量表进行测量。行走距离也将进行评估。以患者为中心的评估将包括苏黎世跛行问卷、健康相关生活质量简表12、欧洲五维健康量表5级以及患者整体变化印象。
本研究结果将证实药物注射疗法与传统非手术治疗相比的疗效，从而有助于优先开展以患者为中心的LSS干预措施。
本研究已在Clinicaltrials.gov（注册标识符：NCT05242497）和CRiS（注册标识符：KCT0007145）注册。
