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Completed

NCT Number: NCT04045457

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • spontaneous soft tissue pain in shoulder and neck region

Exclusion criteria

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

Treatment and study plan

dry needling

Procedure

insertion of needle into active myofascial trigger point

Primary outcomes

  1. Verbal Analog Scale

    Time frame: change from baseline to 3 weeks and at 8 weeks

    scale of 0-10 as a measure of pain severity

  2. Presence of myofascial trigger point

    Time frame: 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

  3. Brief Pain Inventory

    Time frame: change from baseline to 3 weeks and at 8 weeks

    Validated scale of pain severity and interference

Secondary outcomes

  1. Oswestry Disability Scale

    Time frame: change from baseline to 3 weeks and at 8 weeks

    self-reports of disability

  2. MOS-short form 36 v2

    Time frame: change from baseline to 3 weeks and at 8 weeks

    self-reports of disability and health related quality of life Profile of Mood States, range of motion of neck and shoulder, manual muscle test)

  3. Manual Muscle test

    Time frame: change from baseline to 3 weeks and at 8 weeks

    grade strength 0-5, neck and shoulder girdle muscle

  4. Profile of Mood States

    Time frame: change from baseline to 3 weeks and at 8 weeks

    measures of mood and affect (depression and anxiety)

  5. range of motion

    Time frame: change from baseline to 3 weeks and at 8 weeks

    shoulder and neck range of motion in degrees

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: MTrP

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2019
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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