Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus 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 the upper abdominal pain of cancer patients
详细描述
Neurolytic celiac plexus block (NCPB) is a commonly performed procedure in patients with intractable pain due to malignancies involving the upper and mid abdomen. Recently, acupuncture is used as one of alternative interventions to treat cancer-related pains. This pilot study aims to investigate the effectiveness of pain-relief of acupuncture via comparing acupuncture plus NCPB with NCPB alone. Total 14 cancer patients with NCPB will be randomized into two groups of acupuncture and control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Upper abdominal pain VAS ≥ 5
- •Unresectable abdominal malignancy, moderate or severe abdominal pain poorly controlled with pharmacotherapy.
- •All patients had advanced cancer diagnosed by histological/cytological examination
- •Follow-up possible during the clinical trial
- •Written informed consent voluntarily
排除标准
- •Patient with uncorrectable coagulopathy
- •Patient with allergy to local anesthesics or alcohol..
- •Previous NCPB or had implanted epidural or intrathecal analgesic therapy
- •Inability to lie prone
- •Disease encasing the celiac plexus on computed Tomography scan
- •Patients with psychiatric diseases that could have affected the study assessments
- •Significant renal or hepatic disease
- •Inability to comprehend or express oneself in the Korean language
- •Refusal to participate in the trial or to provide informed consent
研究组 & 干预措施
Acupuncture & NCPB
The NCPB will be administered once at the start of the trial and the acupuncture will be performed 3 times per week for 2 weeks (6 times in total).
干预措施: Acupuncture (Device)
Acupuncture & NCPB
The NCPB will be administered once at the start of the trial and the acupuncture will be performed 3 times per week for 2 weeks (6 times in total).
干预措施: Neurolytic celiac plexus block (NCPB) (Procedure)
NCPB
The NCPB alone will be applied to the patients in this group, once at the start of the trial.
干预措施: Neurolytic celiac plexus block (NCPB) (Procedure)
结局指标
主要结局
Visual analogue scale(VAS)
时间窗: Change from baseline to 2 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 1 week, after 2 week, and 1 week follow-up.
次要结局
- Analgesic drug consumption(Change from baseline to 2 weeks)
研究者
Jin Yong Jung
Department of anesthesiolgy
Daegu Catholic University Medical Center