Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06194812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Clinical Important Change of the Turkish Versions of the FABQ TKS, and PCS in Patients With Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], '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': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear-Avoidance', 'timeFrame': 'baseline and after 8 weeks', 'description': 'It is aimed to evaluate the responsibility and minimal clinical significance of the Fear-Avoidance Beliefs Questionnaire in patients with non-specific chronic neck pain.'}], 'secondaryOutcomes': [{'measure': 'Kinesiophobia', 'timeFrame': 'baseline and after 8 weeks', 'description': 'It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Tampa Kinesiophobia scale in patients with non-specific chronic neck pain.'}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'baseline and after 8 weeks', 'description': 'It is aimed to evaluate the responsibility and minimal clinical significance of the Turkish versions of the Pain Catastrophizing scale in patients with non-specific chronic neck pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain', 'Kinesiophobia', 'Fear of Movement']}, 'descriptionModule': {'briefSummary': 'To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.', 'detailedDescription': 'To investigate the reliability and sensitivity of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale, and Pain Catastrophizing Scale in patients with chronic nonspecific neck pain undergoing multidisciplinary rehabilitation and to determine the most appropriate minimally clinically significant difference values in order to increase confidence in their use in clinical practice and research for this patient population. Therefore, the current study aims to evaluate the answerability and minimal clinical significance of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia scale, and Pain Catastrophizing scales in patients with non-specific chronic neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:A definitive diagnosis of chronic nonspecific neck pain (documented history of neck pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain)\n\n* Good Turkish communication skills\n* Both genders must be between the ages of 18 and 65,\n* Agreeing to participate in the research and signing the voluntary consent form\n\nExclusion Criteria:\n\n* Systemic disease, cognitive impairment (Mini Mental State Examination \\<24),\n\n * Recent (\\<12 weeks) myocardial infarction, cerebrovascular accident\n * Rheumatoid arthritis, neurological disorders, radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the cervical region.\n * Having previously received any exercise therapy and/or pain neuroscience training.\n * Refusal of treatment or failure to comply with treatment ('}, 'identificationModule': {'nctId': 'NCT06194812', 'briefTitle': 'Minimal Clinical Important Change of the Turkish Versions of the FABQ TKS, and PCS in Patients With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Evaluation of the Responsibility and Minimal Clinical Important Change of the Turkish Versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Kinesiophobia Scale,and Pain Catastrophizing Scale in Patients With Chronic Neck Pain.', 'orgStudyIdInfo': {'id': '2023-19/651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'İNTERVENTİON', 'description': 'The surveys in the study will be applied to the patients in this group and initial and final measurements will be taken.', 'interventionNames': ['Other: Pain Catastrophizing scale']}], 'interventions': [{'name': 'Pain Catastrophizing scale', 'type': 'OTHER', 'otherNames': ['Fear-Avoidance Beliefs Questionnaire, and Pain Catastrophizing scale', 'Tampa Kinesiophobia scale'], 'description': 'Participants\' fear and avoidance behaviors will be evaluated with the Fear Avoidance Beliefs Questionnaire (KKBS) (Appendix 2).\n\nParticipants\' fear of movement will be evaluated with the Tampa Kinesiophobia Scale (TKS) (Appendix 3).\n\nPain Catastrophizing Scale (PAS) (Appendix 4) will be used to evaluate the participants\' pain-related thoughts and feelings.\n\nThe amount of improvement in symptoms perceived by the participants will be evaluated at the end of the treatment with the Global Perceived Impact Scale (GAES) (Appendix 5). Participants were asked "How would you describe your current situation compared to the beginning of treatment?" question will be asked.', 'armGroupLabels': ['İNTERVENTİON']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Asiye Koçak', 'role': 'CONTACT'}], 'facility': 'Avicenna Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ırmak çavuşoğlu, PhD', 'role': 'CONTACT', 'email': 'irmak.cavusoglu@acibadem.edu.tr', 'phone': '05346028050'}, {'name': 'Irmak çavuşoğlu', 'role': 'CONTACT', 'email': 'irmak2244@gmail.com'}], 'overallOfficials': [{'name': 'Nuray Alaca, assoc.prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Acibadem University'}, {'name': 'Elif Esma Safran, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Acibadem University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Irmak ÇAVUŞOĞLU', 'investigatorAffiliation': 'Acibadem University'}}}}