A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points
MTrP
2 other identifiers
interventional
85
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedAugust 5, 2019
August 1, 2019
5.6 years
June 10, 2016
August 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Oswestry Disability Scale
change from baseline to 3 weeks and at 8 weeks
MOS-short form 36 v2
change from baseline to 3 weeks and at 8 weeks
Manual Muscle test
change from baseline to 3 weeks and at 8 weeks
Profile of Mood States
change from baseline to 3 weeks and at 8 weeks
range of motion
change from baseline to 3 weeks and at 8 weeks
Study Arms (1)
SIngle arm
OTHERSingle arm, intervention All recipients were treated with dry needling technique into active myofascial trigger points They received 1 treatment weekly for three weeks.
Interventions
Eligibility Criteria
You may qualify if:
- spontaneous soft tissue pain in shoulder and neck region
You may not qualify if:
- recent fracture, neurological injury or history of stroke, use of opioids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (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.
PMID: 26491094RESULTGerber 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.
PMID: 25661462RESULTGerber 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.
PMID: 23810811RESULTTuro 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.
PMID: 23493615RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2016
First Posted
August 5, 2019
Study Start
August 1, 2010
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 5, 2019
Record last verified: 2019-08