Clinical trial NCT04045457: A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points
Official title: A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Keywords: active trigger points
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-08-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

* spontaneous soft tissue pain in shoulder and neck region

Exclusion Criteria:

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

Primary outcomes:
measure: Verbal Analog Scale
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: Presence of myofascial trigger point
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: Brief Pain Inventory
timeFrame: change from baseline to 3 weeks and at 8 weeks
Secondary outcomes:
measure: Oswestry Disability Scale
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: MOS-short form 36 v2
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: Manual Muscle test
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: Profile of Mood States
timeFrame: change from baseline to 3 weeks and at 8 weeks
measure: range of motion
timeFrame: change from baseline to 3 weeks and at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.
citation: Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
citation: Gerber LH, Sikdar S, Armstrong K, Diao G, Heimur J, Kopecky J, Turo D, Otto P, Gebreab T, Shah J. A systematic comparison between subjects with no pain and pain associated with active myofascial trigger points. PM R. 2013 Nov;5(11):931-8. doi: 10.1016/j.pmrj.2013.06.006. Epub 2013 Jun 28.
citation: Turo D, Otto P, Shah JP, Heimur J, Gebreab T, Zaazhoa M, Armstrong K, Gerber LH, Sikdar S. Ultrasonic characterization of the upper trapezius muscle in patients with chronic neck pain. Ultrason Imaging. 2013 Apr;35(2):173-87. doi: 10.1177/0161734612472408.