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临床试验/NCT04045457
NCT04045457已完成不适用

A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points

George Mason University0 个研究点目标入组 85 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
主要终点
Brief Pain Inventory

研究概览

简要总结

Determine the effect of dry needling using a 32 gauge needle on active trigger points in subjects with chronic myofascial pain.

Participants will receive treatment for active trigger points (3 on successive weeks) and will have pain, status of the trigger point and functional measures assessed at baseline, after treatment and eight weeks later.

详细描述

Chronic myofascial pain syndromes, such as pain associated with myofascial trigger points (MTrPs), are prevalent yet poorly understood. Our long-term goal is to determine the pathogenesis and pathophysiological mechanisms of chronic pain associated with trigger points, eventually leading to the development of objective diagnostic criteria and effective pain management strategies. We propose to achieve this goal using a new and unique integrative methodology combining microanalytic biochemical assays, ultrasound technology (imaging) and mathematical modeling. An additional component of the study plan is to learn if a standard treatment for MTrPs is associated with the biochemical and ultrasound changes we will be measuring This project has the following specific aims: 1) To understand the viscoelastic soft tissue neighborhood and vascular physiology of affected muscle at a macroscopic level using ultrasound imaging, elastography and Doppler blood flow imaging; 2) To understand the pathophysiology of myofascial trigger points at a nanotechnological level through assays of biochemical milieu using a microdialysis technique; 3) To develop mathematical models of underlying pathophysiological mechanisms based on experimental observations for quantitative hypothesis testing; 4) To determine if dry needle therapy, a standard of care for MTrPs, changes the macroscopic and/or microscopic measurements and leads to resolution of the trigger point and secondarily associated pain symptoms.. Our hypothesis is that pathogenesis of myofascial pain syndrome involves local trauma to the muscle fibers, and the biochemical response to the injury leads to sustained muscle contracture, compression of blood vessels and a local energy crisis that causes tissue hypoxia and the expression of pain-producing substances at myofascial trigger points. Relieving the trigger point through dry needle therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • spontaneous soft tissue pain in shoulder and neck region

排除标准

  • recent fracture, neurological injury or history of stroke, use of opioids

结局指标

主要结局

Brief Pain Inventory

时间窗: change from baseline to 3 weeks and at 8 weeks

Validated scale of pain severity and interference

Verbal Analog Scale

时间窗: change from baseline to 3 weeks and at 8 weeks

scale of 0-10 as a measure of pain severity

Presence of myofascial trigger point

时间窗: change from baseline to 3 weeks and at 8 weeks

Digital palpation of the trigger point was performed by investigators and scored as present or absent; if present was it associated with spontaneous pain or was pain induced with palpation

次要结局

  • MOS-short form 36 v2(change from baseline to 3 weeks and at 8 weeks)
  • Oswestry Disability Scale(change from baseline to 3 weeks and at 8 weeks)
  • Manual Muscle test(change from baseline to 3 weeks and at 8 weeks)
  • range of motion(change from baseline to 3 weeks and at 8 weeks)
  • Profile of Mood States(change from baseline to 3 weeks and at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naomi Lynn Gerber

Professor

George Mason University

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