Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT06825650
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2025-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the CAP Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D000098653', 'term': 'Nociplastic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2025-02-09', 'studyFirstSubmitQcDate': '2025-02-09', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Aspects of Pain Questionnaire (CAP)', 'timeFrame': 'Three months', 'description': 'The CAP questionnaire consists of eight items assessing each of the eight characteristics linked to the central mechanisms of knee pain over the past week. These items assess neuropathic-like pain, fatigue, cognition, catastrophizing, anxiety, depression, sleep, and widespread pain.'}], 'secondaryOutcomes': [{'measure': 'BETY-Biopsychosocial Questionnaire', 'timeFrame': 'Three months'}, {'measure': 'Hospital Anxiety Depression Scale (HADS)', 'timeFrame': 'Three months'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Three months'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Three months'}, {'measure': 'Central Sensitisation Inventory (CSI)', 'timeFrame': 'Three months'}, {'measure': "Short-Form of McGill's Pain Questionnaire", 'timeFrame': 'Three months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nociplastic pain', 'central sensitization', 'back pain', 'osteoarthritis', 'fibromyalgia', 'pain'], 'conditions': ['Osteoarthritis', 'Back Pain', 'Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described. The "CAP questionnaire" is used in people with musculoskeletal pain and diagnostic subgroups of osteoarthritis, back pain, and fibromyalgia. There is no Turkish version of the CAP questionnaire. This study aims to investigate the cultural adaptation, validity, and reliability of the Turkish version of the "CAP questionnaire."', 'detailedDescription': 'Chronic pain is a symptom shared by many musculoskeletal conditions, even when disease management is optimized. Musculoskeletal pathologies are reported to be an essential therapeutic target in pain management. However, these pathologies often do not adequately explain the pain or the reason for its persistence.\n\nCentral sensitization is the increased sensitivity of Central Nervous System (CNS) neurons to a standard nociceptive input. Pain that increases in intensity and distribution beyond that explained by musculoskeletal pathology has been termed "nociplastic pain." Measuring these CNS aspects of pain is a prerequisite for understanding their mechanistic basis and predicting future pain and responses to treatment. Chronic pain is associated with CNS dysfunction in several areas, including depression, anxiety, pain catastrophizing, cognitive dysfunction, sleep disturbance, and fatigue. Considering the increasing importance of assessing mood-related pain (nociplastic pain) The "CAP questionnaire," developed by modifying the CAP-Knee questionnaire to assess potential nociplastic pain features in painful musculoskeletal disorders, has been described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of individuals who come to the university hospital for routine controls.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with musculoskeletal pain and in diagnoses with OA, back pain, or FM\n* Above 18 years of age\n* Informed consent of the participant\n\nExclusion Criteria:\n\n* Diagnosis of uncontrolled/other clinically significant diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06825650', 'briefTitle': 'Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the CAP Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Central Aspects of Pain (CAP) Questionnaire', 'orgStudyIdInfo': {'id': 'SBA 24/997'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with osteoarthritis', 'interventionNames': ['Other: Questionnaire study']}, {'label': 'Individuals with back pain', 'interventionNames': ['Other: Questionnaire study']}, {'label': 'Individuals with fibromyalgia', 'interventionNames': ['Other: Questionnaire study']}], 'interventions': [{'name': 'Questionnaire study', 'type': 'OTHER', 'otherNames': ['CAP questionnaire'], 'description': 'Questionnaire application', 'armGroupLabels': ['Individuals with back pain', 'Individuals with fibromyalgia', 'Individuals with osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Altındağ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Orkun Tüfekçi, PT, PhD(c)', 'role': 'CONTACT', 'email': 'orkuntf@gmail.com', 'phone': '+90 312 305 25 25'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Orkun Tüfekçi, PT, PhD (c)', 'role': 'CONTACT', 'email': 'orkuntf@gmail.com', 'phone': '5319502648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will not be shared to protect the data of individuals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PT, PhD(c)', 'investigatorFullName': 'Orkun Tüfekçi', 'investigatorAffiliation': 'Hacettepe University'}}}}