Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-01 @ 10:31 PM
Study NCT ID:
NCT04045457
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verbal Analog Scale', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'scale of 0-10 as a measure of pain severity'}, {'measure': 'Presence of myofascial trigger point', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': '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'}, {'measure': 'Brief Pain Inventory', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'Validated scale of pain severity and interference'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Scale', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'self-reports of disability'}, {'measure': 'MOS-short form 36 v2', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'self-reports of disability and health related quality of life Profile of Mood States, range of motion of neck and shoulder, manual muscle test)'}, {'measure': 'Manual Muscle test', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'grade strength 0-5, neck and shoulder girdle muscle'}, {'measure': 'Profile of Mood States', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'measures of mood and affect (depression and anxiety)'}, {'measure': 'range of motion', 'timeFrame': 'change from baseline to 3 weeks and at 8 weeks', 'description': 'shoulder and neck range of motion in degrees'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['active trigger points'], 'conditions': ['Myofascial Pain']}, 'referencesModule': {'references': [{'pmid': '26491094', 'type': 'RESULT', '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.'}, {'pmid': '25661462', 'type': 'RESULT', '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.'}, {'pmid': '23810811', 'type': 'RESULT', '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.'}, {'pmid': '23493615', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Determine the effect of dry needling using a 32 gauge needle on active trigger points in subjects with chronic myofascial pain.\n\nParticipants 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spontaneous soft tissue pain in shoulder and neck region\n\nExclusion Criteria:\n\n* recent fracture, neurological injury or history of stroke, use of opioids'}, 'identificationModule': {'nctId': 'NCT04045457', 'acronym': 'MTrP', 'briefTitle': 'A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points', 'organization': {'class': 'OTHER', 'fullName': 'George Mason University'}, 'officialTitle': 'A Study to Determine the Tissue Properties, Vascular Physiology and Biochemical Milieu of Myofascial Trigger Points', 'orgStudyIdInfo': {'id': 'PR00005701'}, 'secondaryIdInfos': [{'id': 'R01AR057348', 'link': 'https://reporter.nih.gov/quickSearch/R01AR057348', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SIngle arm', 'description': 'Single arm, intervention All recipients were treated with dry needling technique into active myofascial trigger points They received 1 treatment weekly for three weeks.', 'interventionNames': ['Procedure: dry needling']}], 'interventions': [{'name': 'dry needling', 'type': 'PROCEDURE', 'description': 'insertion of needle into active myofascial trigger point', 'armGroupLabels': ['SIngle arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Mason University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Naomi Lynn Gerber', 'investigatorAffiliation': 'George Mason University'}}}}