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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04045457
Acronym
MTrP
Enrollment
85
Registered
2019-08-05
Start date
2010-08-31
Completion date
2016-03-31
Last updated
2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain

Keywords

active trigger points

Brief summary

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.

Detailed description

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

Interventions

PROCEDUREdry needling

insertion of needle into active myofascial trigger point

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
George Mason University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* spontaneous soft tissue pain in shoulder and neck region

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Verbal Analog Scalechange from baseline to 3 weeks and at 8 weeksscale of 0-10 as a measure of pain severity
Presence of myofascial trigger pointchange from baseline to 3 weeks and at 8 weeksDigital 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
Brief Pain Inventorychange from baseline to 3 weeks and at 8 weeksValidated scale of pain severity and interference

Secondary

MeasureTime frameDescription
Profile of Mood Stateschange from baseline to 3 weeks and at 8 weeksmeasures of mood and affect (depression and anxiety)
Oswestry Disability Scalechange from baseline to 3 weeks and at 8 weeksself-reports of disability
range of motionchange from baseline to 3 weeks and at 8 weeksshoulder and neck range of motion in degrees
MOS-short form 36 v2change from baseline to 3 weeks and at 8 weeksself-reports of disability and health related quality of life Profile of Mood States, range of motion of neck and shoulder, manual muscle test)
Manual Muscle testchange from baseline to 3 weeks and at 8 weeksgrade strength 0-5, neck and shoulder girdle muscle

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026