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Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain

2019年3月21日 更新者:Kindyle Brennan

Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation

First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.

Research Questions:

  1. Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?
  2. Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?

研究概览

研究类型

介入性

注册 (实际的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Belton、Texas、美国、76513
        • University of Mary Hardin-Baylor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking

Exclusion Criteria:

current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Dry Needling (DN)

Subjects will receive dry needling treatment, once a week, for 6 weeks.

Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).

One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
有源比较器:Dry Needling with Intramuscular electrical stimulation (DNES)

Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks.

Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).

One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Rate of improvement in numerical pain rating scale between groups
大体时间:6 weeks
Between group difference in within group pain changes
6 weeks
Rate of improvement in Neck Disability Index between groups
大体时间:6 weeks
Between group difference of within group disability changes
6 weeks

次要结果测量

结果测量
措施说明
大体时间
Maintenance of pain improvement in both groups
大体时间:week 6 compared to week 12 data
Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
week 6 compared to week 12 data
Maintenance of disability improvement in both groups
大体时间:week 6 compared to week 12 data
Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
week 6 compared to week 12 data

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kindyle L. Brennan, PHD,PT、University of Mary Hardin-Baylor

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月16日

初级完成 (实际的)

2018年12月1日

研究完成 (实际的)

2019年2月1日

研究注册日期

首次提交

2018年8月16日

首先提交符合 QC 标准的

2018年8月16日

首次发布 (实际的)

2018年8月20日

研究记录更新

最后更新发布 (实际的)

2019年3月25日

上次提交的符合 QC 标准的更新

2019年3月21日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • DNvDN-ES

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Dry needling (DN)的临床试验

3
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