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临床试验/NCT03638388
NCT03638388已完成不适用

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

Kindyle Brennan2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Rate of improvement in numerical pain rating scale between groups

研究概览

简要总结

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Dry Needling (DN)

Active Comparator

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).

干预措施: Dry needling (DN) (Procedure)

Dry Needling with Intramuscular electrical stimulation (DNES)

Active Comparator

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).

干预措施: Dry needling with intramuscular electrical stimulation (DNES) (Procedure)

结局指标

主要结局

Rate of improvement in numerical pain rating scale between groups

时间窗: 6 weeks

Between group difference in within group pain changes

Rate of improvement in Neck Disability Index between groups

时间窗: 6 weeks

Between group difference of within group disability changes

次要结局

  • Maintenance of disability improvement in both groups(week 6 compared to week 12 data)
  • Maintenance of pain improvement in both groups(week 6 compared to week 12 data)

研究者

发起方
Kindyle Brennan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kindyle Brennan

Dr. Kindyle L. Brennan, Associate Professor, Doctor of Physical Therapy Program, College of Health Sciences

University of Mary Hardin-Baylor

研究点 (2)

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