Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT01710735
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-18', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle contractility', 'timeFrame': '30 minutes', 'description': 'Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)'}], 'secondaryOutcomes': [{'measure': 'pressure-pain threshold', 'timeFrame': '60 seconds', 'description': 'Algometer measurement of pressure-pain perception'}, {'measure': 'NRS-101', 'timeFrame': '60 seconds', 'description': 'Self-reported pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TP', 'Myofascial pain'], 'conditions': ['Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '23176709', 'type': 'DERIVED', 'citation': 'Myburgh C, Hartvigsen J, Aagaard P, Holsgaard-Larsen A. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points- a randomized intervention study. Chiropr Man Therap. 2012 Nov 25;20(1):36. doi: 10.1186/2045-709X-20-36.'}, {'pmid': '23116179', 'type': 'DERIVED', 'citation': 'Hofer KA, Ruonala R, Albert VA. The double-corolla phenotype in the Hawaiian lobelioid genus Clermontia involves ectopic expression of PISTILLATA B-function MADS box gene homologs. Evodevo. 2012 Nov 1;3(1):26. doi: 10.1186/2041-9139-3-26.'}]}, 'descriptionModule': {'briefSummary': 'In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinically relevant MFTrP of the upper Trapezius musculature\n* Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).\n* BMI less than 31\n\nExclusion Criteria:\n\n* a history of chronic, systemic pathology (e.g. hemophilia)\n* pre-existing neck/shoulder pathology/surgical procedures,\n* clinical depression\n* health-related legal action\n* pregnant\n* anti-inflammatory and/or chronic pain medication\n* had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia'}, 'identificationModule': {'nctId': 'NCT01710735', 'briefTitle': 'Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study', 'orgStudyIdInfo': {'id': 'Muscle and needling'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling (deep)', 'description': 'Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.', 'interventionNames': ['Procedure: Dry needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry needling (superficial)', 'description': 'Insertion of dry needle less than 1cm.', 'interventionNames': ['Procedure: Dry needling']}], 'interventions': [{'name': 'Dry needling', 'type': 'PROCEDURE', 'otherNames': ['Acupuncture'], 'description': 'Insertion of acupuncture needle into a myofascial trigger point.', 'armGroupLabels': ['Dry needling (deep)', 'Dry needling (superficial)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'state': 'Funen', 'country': 'Denmark', 'facility': 'Univ. of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jan Hartvigsen Hartvigsen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univ. of Southern Denmark'}, {'name': 'Per Aagaard, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univ. of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Dansk Kiropraktor Fond', 'class': 'UNKNOWN'}, {'name': 'IMK Almene Fond', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Corrie Myburgh', 'investigatorAffiliation': 'University of Southern Denmark'}}}}