Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis
试验速览
- 阶段
- 不适用
- 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 being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.
详细描述
This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone.
This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •Meyerding Grade I-II spondylolisthesis
- •Low back pain of at least 1-year duration
- •Follow-up possible during the clinical trial
- •Written informed consent voluntarily
排除标准
- •Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes)
- •Previous spine surgery
- •Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
- •Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease)
- •All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes)
- •Alcohol/drug abuse
- •Significant renal or hepatic disease
- •Pregnant, lactating or planning a pregnancy
- •Hypersensitive reaction to acupuncture treatment
- •Inability to comprehend or express oneself in the Korean language
- •An individual deemed to be ineligible by a physician
- •Refusal to participate in the trial or to provide informed consent
结局指标
主要结局
Visual analogue scale(VAS)
时间窗: Change from baseline to 5 weeks
This outcome will measure changes in the participant's level of low back pain.
次要结局
- Short form McGill pain questionnaire(Chagnes from baseline to 5 weeks)
- Oswestry Disability Index(Changes from baseline to 5 weeks)
- Present pain intensity(PPI)(Changes from baseline to 5 weeks)
- Pain vision(Chagnes from baseline to 5 weeks)
研究者
Un-Suk, Noh (PhD)
Department of anesthesiolgy
Daegu Catholic University Medical Center