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临床试验/NCT03539588
NCT03539588已完成不适用

Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation for the Treatment of Sub-acute and Chronic Low Back Pain in a Military Population: A Randomized Crossover Design

William Beaumont Army Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月12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
入组人数
30
试验地点
1
主要终点
Numeric Pain Rating Scale to assess change

研究概览

简要总结

trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling

详细描述

The purpose of this study is to evaluate if trigger point dry needling with intramuscular electrical stimulation is more effective in decreasing pain and disability in individuals with sub-acute and chronic low back pain (LBP) than with trigger point dry needling alone. The investigators are using a within subjects randomized crossover study that will recruit 30 active duty military personnel or beneficiaries from William Beaumont Army Medical Center and all associated clinics. The investigators hypothesize that individuals with LBP will exhibit larger improvements in pain and disability when receiving trigger point dry needling with intramuscular electrical stimulation than when receiving trigger point dry needling alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Currently experience low back pain for greater than 4 weeks (Low back pain defined as pain below the T12th vertebrae with or without radiation) Military or DOD Beneficiary (any branch; 18-65 years of age)

排除标准

  • •Structural Deformity (ankylosing Spondylitis, Scoliosis)
  • •Has any other Orthopedic condition that may keep subject from performing Low - Back Exercises
  • •Spinal infection or local infection
  • •Pregnancy-All female subjects will be given either a blood serum or urine pregnancy test.
  • •Spinal cord compression or Cauda Equina Syndrome
  • •Subject with the inability to keep appointments
  • •Has History of prior surgery
  • •Has received Dry Needling or Acupuncture in the last 6 months
  • •History of bleeding disorders
  • •High anti-coagulant use
  • •History of immune suppression

研究组 & 干预措施

Treatment group 1

Active Comparator

In this group participants will receive trigger point dry needling with electrical stimulation first and receive trigger point needling by itself second. Only MYOTECH dry needles will be used in this study. However we are not studying the equipment.

干预措施: trigger point dry needling (Device)

Treatment group 1

Active Comparator

In this group participants will receive trigger point dry needling with electrical stimulation first and receive trigger point needling by itself second. Only MYOTECH dry needles will be used in this study. However we are not studying the equipment.

干预措施: Electrical Stimulation (Device)

Treatment Group 2

Active Comparator

In this group the participants will receive trigger point dry needling first and receive trigger point dry needling with electrical stimulation second. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

干预措施: trigger point dry needling (Device)

Treatment Group 2

Active Comparator

In this group the participants will receive trigger point dry needling first and receive trigger point dry needling with electrical stimulation second. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

干预措施: Electrical Stimulation (Device)

结局指标

主要结局

Numeric Pain Rating Scale to assess change

时间窗: Baseline and before and after each treatment session, duration per subject is approximately 3 weeks

an 11 point scale on which the participant will grade their pain

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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