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

Sponsor
George Mason University (Other)
Overall Status
Completed
CT.gov ID
NCT04045457
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
85
1
67

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: dry needling
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: SIngle arm

Single arm, intervention All recipients were treated with dry needling technique into active myofascial trigger points They received 1 treatment weekly for three weeks.

Procedure: dry needling
insertion of needle into active myofascial trigger point

Outcome Measures

Primary Outcome Measures

  1. Verbal Analog Scale [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 [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 [change from baseline to 3 weeks and at 8 weeks]

    Validated scale of pain severity and interference

Secondary Outcome Measures

  1. Oswestry Disability Scale [change from baseline to 3 weeks and at 8 weeks]

    self-reports of disability

  2. MOS-short form 36 v2 [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 [change from baseline to 3 weeks and at 8 weeks]

    grade strength 0-5, neck and shoulder girdle muscle

  4. Profile of Mood States [change from baseline to 3 weeks and at 8 weeks]

    measures of mood and affect (depression and anxiety)

  5. range of motion [change from baseline to 3 weeks and at 8 weeks]

    shoulder and neck range of motion in degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Naomi Lynn Gerber, Professor, George Mason University
ClinicalTrials.gov Identifier:
NCT04045457
Other Study ID Numbers:
  • PR00005701
  • R01AR057348
First Posted:
Aug 5, 2019
Last Update Posted:
Aug 5, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Naomi Lynn Gerber, Professor, George Mason University

Study Results

No Results Posted as of Aug 5, 2019