Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05698069
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2023-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of Pain Modulation Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the Turkish version of pain modulation index', 'timeFrame': '15 days', 'description': "Internal consistency was evaluated by test retest method and calculating the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency"}, {'measure': 'Validity of the Turkish version of Pain Modulation Index', 'timeFrame': '1 day', 'description': 'Index scores were analysed for their correlation with Pain Detect and Central Sensitization Inventory scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '31785195', 'type': 'BACKGROUND', 'citation': 'Austin PD, Asghari A, Costa DSJ, Siddall PJ. The development of a novel questionnaire assessing alterations in central pain processing in people with and without chronic pain. Scand J Pain. 2020 Apr 28;20(2):407-417. doi: 10.1515/sjpain-2019-0087.'}]}, 'descriptionModule': {'briefSummary': 'In order to assess the validity and reliability of the Turkish version of Pain Modulation Index, 125 volunteers with chronic pain were enrolled in the study. Test and re-test method was used to assess reliability and correlation analyses with Pain Detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire. Turkish version of the Pain Modulation Index was found to be a valid and reliable tool for evaluating chronic pain.', 'detailedDescription': 'Pain Modulation Index is a questionnaire that was developed in English for the assessment of chronic pain for qualities consistent with central sensitization. The English version of the questionnaire was translated into Turkish by two physicians than back translated into English by two separate bilingual translators. Initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study. They answered the questions twice, 15 days apart. In addition to the Turkish version of the Pain Modulation Index, on the first visit, they were also asked to answer Pain Detect and Central Sensitization Inventory. Their answers were analysed to assess the validity and reliability of the Turkish version of Pain Modulation Index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had non-cancer pain for more than 3 months duration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of chronic non-cancer pain of more than 3 months duration\n\nExclusion Criteria:\n\n* Illiteracy\n* Refusal to take part in the study'}, 'identificationModule': {'nctId': 'NCT05698069', 'briefTitle': 'Turkish Version of Pain Modulation Index', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Reliability and Validity of the Turkish Version of the Pain Modulation Index', 'orgStudyIdInfo': {'id': '21-7T/44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic pain', 'description': 'Patients with non-cancer pain of more than 3 months duration.', 'interventionNames': ['Diagnostic Test: Pain Modulation Index', 'Other: Pain Detect', 'Other: Central sensitization inventory']}], 'interventions': [{'name': 'Pain Modulation Index', 'type': 'DIAGNOSTIC_TEST', 'description': "A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.", 'armGroupLabels': ['Patients with chronic pain']}, {'name': 'Pain Detect', 'type': 'OTHER', 'description': 'A questionnaire that was validated for the assessment of neuropathic pain', 'armGroupLabels': ['Patients with chronic pain']}, {'name': 'Central sensitization inventory', 'type': 'OTHER', 'description': 'A questionnaire developed for the detection of central sensitization.', 'armGroupLabels': ['Patients with chronic pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '355100', 'city': 'Bornova', 'state': 'İzmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Hospital, Department of Physical and rehabilitation medicine', 'geoPoint': {'lat': 38.47921, 'lon': 27.2399}}], 'overallOfficials': [{'name': 'Simin Hepguler, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ece Cinar', 'investigatorAffiliation': 'Ege University'}}}}