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临床试验/NCT01376375
NCT01376375已完成1 期

A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年6月10日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
5
试验地点
2
主要终点
To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP

研究概览

简要总结

Background:

  • Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Researchers will look at blood samples for changes in different chemicals related to inflammation and pain.

Objectives:

  • To test the effect of acupuncture on blood chemicals associated with chronic low back pain.

Eligibility:

  • People at least 18 years of age who have chronic low back pain.
  • Those who have had back surgery or had acupuncture for any medical condition may not participate.

Design:

  • This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.
  • At the first study visit, participants will give a medical history and complete two questionnaires about their low back pain. They will also spend 30 minutes lying down on a bed, relaxing quietly.
  • The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic the standard procedure, but no needles will be used. The standard procedure will be performed in the same location. A licensed, experienced acupuncturist will insert small disposable needles into acupuncture sites on the back, arms, and legs. Those in the study will not know whether they are receiving the sham or the standard acupuncture procedure.
  • At some visits, participants will provide blood samples for testing. At every visit, participants will complete the questionnaires about low back pain.

详细描述

Objective:

Inflammation and primary mechanical derangements are thought to be the two major causes leading to low back pain (LBP) syndromes. Increasing evidence suggests that cytokines and hormones, including IFN-gamma, IL-17, IL-1beta, IL-6, TNF-alpha, MMP10, NGF, PGE2, NO and IL-8, play critical roles in the pathogenesis of inflammatory LBP. This study will investigate the effect of acupuncture on LBP by measuring serum cytokine and hormone levels before and after treatment in participants. To define the molecular mechanism by which acupuncture affects LBP, histone modification, including H3K4me3 and H3K27me3, as well as methylation patterns of CpG islands on the promoters of selected genes in the peripheral CD4(plus) T cells will be also tested.

Study Population:

Five participants with chronic LBP will receive treatment.

Design:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP

次要结局

未报告次要终点

研究者

研究点 (2)

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