Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-01 @ 5:52 PM
Study NCT ID:
NCT01826695
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2013-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurodynamic Intervention in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anxiety and depression', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes from baseline to postintervention in anxiety and depression in the participants. Participants completed the Hospital Anxiety and Depression Scale in order to assess these parameters.'}], 'primaryOutcomes': [{'measure': 'Nervous assessment', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes from baseline to postintervention measured with neurodynamic tests This is to test upper extremities. It moves most of the nerves between the neck and hand, including the median nerve, radial and ulnar, brachial plexus, spinal nerves and cervical nerve roots.\n\nThe patient is placed supine position. It is measured with a goniometer.'}], 'secondaryOutcomes': [{'measure': 'Manual dexterity', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes from baseline to postintervention in dexterity. This is assessed using the Purdue Pegboard Test.\n\nThe Purdue pegboard test is a timed physical test used to measure manual dexterity. Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process.'}, {'measure': 'Grip strength', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes from baseline to postintervention in grip strength. This is measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved from all six attempts was used in analyses.\n\nKg/cm2'}, {'measure': 'Pressure pain measure', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes in pain pressure threshold from baseline to 8-weeks intervention. This is going to be measured in three points in upper extremities using the pressure algometer. All assessments were made by the same investigator. All the subjects were trained to familiarize the subjects with the pressure algometry procedure before the measures in an anatomical site different from the chosen sites for this study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibromyalgia, neurodynamic, dexterity'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '26143052', 'type': 'BACKGROUND', 'citation': 'Torres JR, Martos IC, Sanchez IT, Rubio AO, Pelegrina AD, Valenza MC. Results of an Active Neurodynamic Mobilization Program in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Oct;96(10):1771-8. doi: 10.1016/j.apmr.2015.06.008. Epub 2015 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population.\n\nFibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.', 'detailedDescription': 'Fibromyalgia affects women nine times more than men.The pathophysiology of fibromyalgia is being studied nowadays in order to understand the mechanisms implicated in it.\n\nThe treatment propose in this study is a neurodynamic intervention. Neurodynamics is the term used to describe the integration of the morphology, biomechanics and physiology of the nervous system.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada.\n* Women who can complete the assessment battery of tests at the beginning and at the end of the study\n* Female sex.\n\nExclusion Criteria:\n\n* Male sex.\n* Auditive and visual disturbances.\n* Cognitive problems.\n* Psychiatric pathology.\n* Traumatic pathology of the hand.'}, 'identificationModule': {'nctId': 'NCT01826695', 'acronym': 'FM', 'briefTitle': 'Neurodynamic Intervention in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Study of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.', 'orgStudyIdInfo': {'id': 'DF0040UG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '35 women are recruited in order to the inclusion criteria for the study. Placebo controlled. They received only standard treatment without neurodynamic intervention. They are diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada. The study include subjects who can complete the assessment battery of tests at the beginning and end.', 'interventionNames': ['Other: Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neurodynamic technique group', 'description': '35 women are recruited, diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada. The study include subjects who can complete the assessment battery of tests at the beginning and at the end.', 'interventionNames': ['Other: Neurodynamic technique group']}], 'interventions': [{'name': 'Neurodynamic technique group', 'type': 'OTHER', 'otherNames': ['Neurodynamic sliding technique', 'Nerve mobilization'], 'description': 'Neurodynamic techniques are used in order to move most of the nerves between the neck and hand, including the median nerve, radial and ulnar, brachial plexus, spinal nerves and cervical nerve roots.\n\nThe patient is placed supine position. The treatment will be carry out 3 times per week during 8 weeks.', 'armGroupLabels': ['Neurodynamic technique group']}, {'name': 'Placebo group', 'type': 'OTHER', 'otherNames': ['Standard treatment.'], 'description': 'Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Faculty of Health Sciences. University of Granada.', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Marie Carmen Valenza, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}