Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05328518
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2022-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D012559', 'term': 'Schizophrenia'}], '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'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the self-reported extent by questionnarie and intensity of pain with selected tender points examination.', 'timeFrame': '1 day', 'description': 'To compare the self-reported extent and intensity of pain with selected tender points examination.'}, {'measure': 'To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia.', 'timeFrame': '1 day', 'description': 'To compare between the degrees in pain recognition in schizophrenia patients who suffer from fibromyalgia to pain recognition in schizophrenia patients who do not suffer from fibromyalgia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Numerous studies reported on comorbidity of fibromyalgia and psychiatric disorders. Approximately 30% of patients with fibromyalgia have major depression at the time of diagnosis; the lifetime prevalence of depression is 74% and that of an anxiety disorder is 60%. In some fibromyalgia patients, mood and cognitive problems are much more prominent than tenderness. From the psychiatric point of view, 49% of PTSD patients and 5% of major depression patients fulfill criteria for diagnosing fibromyalgia.\n\nThe association between schizophrenia and fibromyalgia is still unknown.\n\nStudy hypothesis Schizophrenia patients, who have an aberrant sensation of pain, have lower prevalence of FM compared to the general population.\n\nPrimary objectives\n\n1. Demonstrate that schizophrenia patients have lower prevalence of FM, compared to the general population.\n2. To compare the self-reported extent and intensity of pain with selected tender points examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'schizophrenic womens', 'genderDescription': 'Women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women above 18 years of age.\n* Patients must meet DSM-5 criteria for a diagnosis of schizophrenia.\n* A stabled mental state.\n* If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms.\n\nExclusion Criteria:\n\n* Mental co-morbidity.\n* Diagnosis of myofascial pain syndrome or chronic fatigue syndrome.\n* Alcohol or drug use.\n* Usage of any pain reliever medications during the week before recruitment.'}, 'identificationModule': {'nctId': 'NCT05328518', 'briefTitle': 'Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Soft Tissue Tenderness and Fibromyalgia Among Schizophrenia Patients.', 'orgStudyIdInfo': {'id': '0052-20 EMC'}}, 'contactsLocationsModule': {'locations': [{'zip': '1910500', 'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'gilat ron avraham', 'role': 'CONTACT', 'email': 'gilataavraham@gmail.com', 'phone': '0528495336'}], 'facility': 'Haemek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pricipal investigator', 'investigatorFullName': 'Einat Mader', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}