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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain
• Intervention / Treatment: Procedure: dry needling

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• spontaneous soft tissue pain in shoulder and neck region

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Analog Scale	scale of 0-10 as a measure of pain severity	change from baseline to 3 weeks and at 8 weeks
Presence of myofascial trigger point	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	change from baseline to 3 weeks and at 8 weeks
Brief Pain Inventory	Validated scale of pain severity and interference	change from baseline to 3 weeks and at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Scale	self-reports of disability	change from baseline to 3 weeks and at 8 weeks
MOS-short form 36 v2	self-reports of disability and health related quality of life Profile of Mood States, range of motion of neck and shoulder, manual muscle test)	change from baseline to 3 weeks and at 8 weeks
Manual Muscle test	grade strength 0-5, neck and shoulder girdle muscle	change from baseline to 3 weeks and at 8 weeks
Profile of Mood States	measures of mood and affect (depression and anxiety)	change from baseline to 3 weeks and at 8 weeks
range of motion	shoulder and neck range of motion in degrees	change from baseline to 3 weeks and at 8 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: active trigger points
• Other Study ID Numbers: PR00005701; R01AR057348 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No