Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-06 @ 1:35 PM
Study NCT ID:
NCT02856334
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D056650', 'term': 'Vulvodynia'}, {'id': 'D060545', 'term': 'Pudendal Neuralgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interview on psychosocial factors', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Survey of Pain Attitudes-35 (SOPA-35)', 'timeFrame': 'Day 1'}, {'measure': 'Multidimensional Pain Inventory (MPI) - Interference Scale', 'timeFrame': 'Day 1'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'Day 1'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Day 1'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Day 1'}, {'measure': 'Coping Strategies Questionnaire (CSQ)', 'timeFrame': 'Day 1'}, {'measure': 'Tampa Scale for Kinesiophobia (TSK) -11', 'timeFrame': 'Day 1'}, {'measure': 'Neurophysiology of pain questionnaire (NPQ)', 'timeFrame': 'Day 1'}, {'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': 'Day 1'}, {'measure': 'Patient Specific Functional Scale (PSFS)', 'timeFrame': 'Day 1'}, {'measure': 'Patient Health Questionnaire (PHQ)', 'timeFrame': 'Day 1'}, {'measure': 'Quantitative Sensory Testing-Pain Pressure Threshold (PPT)', 'timeFrame': 'Day 2', 'description': 'in kg/s'}, {'measure': 'Quantitative Sensory Testing-Temporal Summation (TS)', 'timeFrame': 'Day 2', 'description': 'in kg/s'}, {'measure': 'Quantitative Sensory Testing-Conditioned Pain Modulation (CPM)', 'timeFrame': 'Day 2', 'description': 'in kg/s'}]}, 'conditionsModule': {'keywords': ['chronic pelvic pain', 'vulvodynia', 'pelvic pain', 'psychosocial factors', 'central sensitization'], 'conditions': ['Pelvic Pain', 'Vulvodynia', 'Pudendal Neuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.', 'detailedDescription': 'This study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. In addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with chronic pelvic pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 55 years\n* Chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures\n* Pain duration ≥6 months\n* Average pain intensity ≥3/10 in NRS during the previous week\n* To understand the objectives of the study\n\nExclusion Criteria:\n\n* Suspicion or knowledge of current organic pathology that requires medical or surgical treatment\n* Pain as a consequence of surgery known\n* Pending litigation or financial compensation\n* Psychiatric disorders: major depression, bipolar syndrome, etc ..\n* Cognitive difficulties\n* Not sign the informed consent'}, 'identificationModule': {'nctId': 'NCT02856334', 'briefTitle': 'Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain', 'orgStudyIdInfo': {'id': '0117'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic pelvic pain', 'description': 'Women with chronic pelvic pain'}, {'label': 'Control group', 'description': 'Healthy women'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46021', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Rafael Torres', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46021', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Rafael Torres-Cueco', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT', 'investigatorFullName': 'Rafael Torres Cueco', 'investigatorAffiliation': 'University of Valencia'}}}}