Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
This study is to investigate the effectiveness of acupuncture for alleviating pain from Spinal Compression Fracture in Patients Treated with Nerve Block.
详细描述
Spinal compression fracture is mainly caused by trauma, furthermore, in old age, osteoporosis increases the risk of spinal compression fracture. Nerve block is effective for the management of pain from inflammation or nerve root stimulation from spinal compression fracture. As one of alternative interventions, acupuncture is effective for controlling spinal compression fracture.
This study aims to investigate that combination with acupuncture and nerve block may relieve spinal compression fracture-related pain versus nerve block alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vertebral compression fracture by trauma or osteoporosis
- •Minimum 15% height loss of vertebrae
- •Patient diagnosed with x-ray or computed tomography (CT) or magnetic resonance image (MRI)
- •Visual analogue scale (VAS) score of 5 or more
- •Age over 50
- •2 weeks from onset or more
- •Follow-up possible during the clinical trial
- •Written informed consent voluntarily
排除标准
- •Within 2 weeks from onset
- •Pathological fracture due to malignancy/myeloma, osteomyelitis
- •Major retropulsion of bony segments into the spinal canal
- •Bone metabolic disease
- •Significant renal or hepatic disease
- •Hypersensitive reaction to acupuncture treatment
- •Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
- •Alcohol/drug abuse
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: Change from baseline to 5 weeks
The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 3 week, and 5 week (2 weeks follow-up).
次要结局
- Oswestry Disability Index (ODI)(Change from baseline to 5 weeks)
- Short form McGill pain questionnaire(Change from baseline to 5 weeks)
研究者
Jin Yong Jung
Department of anesthesiolgy
Daegu Catholic University Medical Center