Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03402867
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Dry Needling on Neck and Shoulder Pain in Orchestral Musicians: a Prospective Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Deep dry needling'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-05', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale for pain', 'timeFrame': '2 weeks', 'description': 'Pain measurement. 100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': '2 weeks', 'description': 'Analogic algometer'}, {'measure': 'Neck disability index (NDI)', 'timeFrame': '2 weeks', 'description': '10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. It assesses four items regarding subjective symptoms (pain intensity, headache, concentration, sleeping), four items regarding activities of daily living (lifting, work, driving, recreation), and two items regarding discretionary activities of daily living (personal care, reading). Each item is scored 0 to 5, with the total reported as either a raw score (0-50) or as a percentage score. Higher values represent a worse outcome.'}, {'measure': 'Shoulder pain disability index (SPADI)', 'timeFrame': '2 weeks', 'description': 'Self-administered questionnaire, grouping 13 questions, 5 of which measure the severity of pain caused by various arm movements involving the shoulder, the pain being assessed on a numeric pain scale ranging from 0 to 10. Eight additional questions related to functional impairments of the shoulder are assessed with a numeric scale. Higher values represent a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Syndrome', 'Musculoskeletal Pain', 'Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orchestral musicians\n* Chronic neck or shoulder pain\n* Presence of active myofascial trigger points\n\nExclusion Criteria:\n\n* Fear of needles\n* Coagulation disorders\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03402867', 'briefTitle': 'Effects of Dry Needling on Neck and Shoulder Pain in Orchestral Musicians: a Prospective Case Series', 'organization': {'class': 'OTHER', 'fullName': 'CEU San Pablo University'}, 'officialTitle': 'Effects of Myofascial Trigger Point Dry Needling on Neck Pain in Orchestral Musicians', 'orgStudyIdInfo': {'id': 'CEU-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Deep dry needling applied on active myofascial trigger points in the shoulder and neck regions', 'interventionNames': ['Procedure: Deep dry needling']}], 'interventions': [{'name': 'Deep dry needling', 'type': 'PROCEDURE', 'description': 'Insertion of a filiform needle in the active trigger point of musculoskeletal muscle', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28668', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'CEU San Pablo University', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CEU San Pablo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Aitor Martin-Pintado Zugasti', 'investigatorAffiliation': 'CEU San Pablo University'}}}}