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首页> 外文期刊>Journal of Pharmacopuncture >Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial
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Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

机译：针刺椎体压缩性骨折的患者：一项随机，对照，初步临床试验的协议。

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Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVisionTM system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.
机译：目的：脊柱X线片显示椎体压缩性骨折（VCF）的特点是背痛和椎体骨折。胸腰椎的VCF在老年人中很常见。通常，应开处方适当的止痛药以减轻疼痛，从而促进早期动员。 VCF的理想治疗方法尚未确定。在韩国，针灸和草药已用于治疗VCF多年。有经验证据表明，针灸可能会使VCF患者受益。但是，尚未发表评估针灸治疗VCF的功效和安全性的随机对照临床试验。因此，我们设计了一项随机，对照，试验性的临床试验，以获得设计进一步的大规模试验所需的信息。方法：提出了为期五周的随机，对照，试验性临床试验方案。将招募14名患者并将其随机分为两组：一个对照组，每周一次接受层状硬膜外类固醇注射，持续3周;一个实验组，接受层间硬膜内类固醇注射，再加上针灸治疗（每周3次针刺，共3周，每组9个）总会话数）。主要结果将是疼痛强度（视觉模拟量表和PainVision TM 系统）。次要结果测量将是简短的McGill疼痛问卷和oswestry残疾指数的答案。将在基线以及一，三和五周进行评估。最后的评估（第五周）将在治疗终止后两周进行。这项研究将为未来的大规模试验提供可行性指示和临床基础。结果将提供更多资源，将针灸纳入现有治疗方法，例如非甾体类抗炎药，麻醉药和椎骨扩张术。本文介绍了该协议。

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