Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT01725295
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2012-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurostructural Integration Technique for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-09', 'studyFirstSubmitDate': '2012-11-08', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia treatment', 'physical therapy', 'hydrotherapy'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have found that our patients seem to benefit from a soft tissue physical therapy called neurostructural integration therapy (NST). The purpose of this study was to compare NST to hydrotherapy which is already used to manage fibromyalgia symptoms.', 'detailedDescription': 'Twenty female patients who met the American College of Rheumatology diagnostic criteria for the classification of FM were enrolled in the study. Patients were randomly allocated to receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six weeks, three months, and six months. Primary outcome measures included the SF-36 quality of life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score. Duration of morning stiffness and duration of weekly aerobic exercise as reported by the participants were secondary outcome measures. Statistics analysis was performed by standard parametric and non parametric methods.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who fulfills ACR diagnostic criteria for fibromyalgia\n\nExclusion Criteria:\n\n* Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression'}, 'identificationModule': {'nctId': 'NCT01725295', 'acronym': 'NST', 'briefTitle': 'Neurostructural Integration Technique for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University College Dublin'}, 'orgStudyIdInfo': {'id': 'NST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NST', 'description': 'A form of physical therapy to relieve symptoms of fibromyalgia', 'interventionNames': ['Other: NST']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrotherapy', 'description': 'An alternate form of physical therapy to relieve symptoms of fibromyalgia', 'interventionNames': ['Other: Hydrotherapy']}], 'interventions': [{'name': 'NST', 'type': 'OTHER', 'description': 'A form of physical therapy', 'armGroupLabels': ['NST']}, {'name': 'Hydrotherapy', 'type': 'OTHER', 'otherNames': ['A form of physical therapy'], 'armGroupLabels': ['Hydrotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Dublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Rheumatologist', 'investigatorFullName': 'Professor Geraldine McCarthy', 'investigatorAffiliation': 'University College Dublin'}}}}