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临床试验/NCT03489681
NCT03489681Unknown不适用

Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

Sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic burden. A meta-analysis of sciatica treatment revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might relieve pain. However, the central effect of acupuncture-induced analgesia and its functional connectivities in various brain region remain unclear. Besides, the number of acupoints selection and its correlation in functional connectivity also need to be discussed. This clinical trial would collect the sciatica subjects assign by intent to treat, divided to acupuncture and non-acupuncture herbal control group. The treatment of acupuncture assigns randomized as high dose and low dose acupuncture group. The acupuncture will perform two times a week for four weeks. The primary outcomes are visual analog scale for pain and sciatica bothersomeness index; the secondary outcomes are Roland's disability questionnaire for sciatica, WHOQOL, and traditional Chinese medical constitutional scale. The functional magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment. This study aims to explore the model of DMN in sciatica patients; it's central effect in different stimulation modality and to investigate the mechanism of the long-lasting, sustained impact in different acupuncture dosage.

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •35 - 70 y/o.
  • •Low back or gluteal pain radiating into one leg.
  • •Pain duration of at least two weeks.

排除标准

  • •Known or suspected severe spinal pathology (for example, cauda equina syndrome, or spinal fracture).
  • •Pregnant or breastfeeding women.
  • •Scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8-week treatment period.
  • •Administration of sedative or analgesics within 24 h before the fMRI scan.
  • •Comorbidities include systemic malignancy, bleeding tendency, rheumatic arthritis and other known autoimmune diseases.
  • •Focal neurologic deficits with progressive or disabling symptoms
  • •History of received acupuncture treatment in the past one month.
  • •Any contraindication related to acupuncture and MRI.
  • •Visual analog scale <
  • •Low back pain without sciatica.

研究组 & 干预措施

Acupuncture, high dosage

Experimental

treat as 18 acupoints

干预措施: acupuncture (Device)

Control group

No Intervention

no acupuncture treatment, healthy control

Acupuncture, low dosage

Experimental

treat as six acupoints

干预措施: acupuncture (Device)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: Change from Baseline VAS at 4 weeks

pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain, the higher values represent, the worse outcome

次要结局

  • Sciatica Bothersome Index (SBI)(Change from Baseline SBI at 4 weeks)
  • The World Health Organization Quality of Life -brief edition (WHOQOL-Brief)(Change from Baseline WHOQOL-Brief at 4 weeks)
  • Body Constitution Questionnaire (BCQ)(baseline (1st time rsMRI examination))
  • Roland Disability Questionnaire for Sciatica (RDQS)(Change from Baseline RDQS at 4 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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