Viewing Study NCT04099160


Ignite Creation Date: 2025-12-25 @ 2:11 AM
Ignite Modification Date: 2026-02-24 @ 4:11 AM
Study NCT ID: NCT04099160
Status: COMPLETED
Last Update Posted: 2024-01-19
First Post: 2019-09-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Turkish Version of Revised Neurophysiology of Pain Questionnaire
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Revised Neurophysiology of Pain Questionnaire', 'timeFrame': 'Two minute', 'description': 'The Revised Neurophysiology of Pain Questionnaire consists of 12 items and measuring the level of knowledge about pain neurophysiology. High score indicates a high level of knowledge about pain neurophysiology.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '1 minute', 'description': 'Visual Analogue Scale assessed pain severity. Visual Analog Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of pain. hence the left end is usually labeled \'no pain\', and the right end usually labeled \'extreme pain\'. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark by using a ruler. The scale is provided a range of scores from 0-100. High score indicates a high level of pain..'}, {'measure': 'Short Form-36', 'timeFrame': 'Ten minute', 'description': 'Short Form-36 (SF-36) questionnaire has 8 subscales such as physical function, role limitations due to physical problems, pain, general perception of health, energy, social function, role limitations due to emotional problems, mental health. This questioonaire evaluate quality of life. Scales have a fairly small range of response options, and scores are multiplied up to 0-100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurophysiology pain questionnaire', 'reliability', 'validity', 'pain', 'low back pain'], 'conditions': ['Chronic Low-back Pain', 'Neck Pain']}, 'referencesModule': {'references': [{'pmid': '23651882', 'type': 'BACKGROUND', 'citation': "Catley MJ, O'Connell NE, Moseley GL. How good is the neurophysiology of pain questionnaire? A Rasch analysis of psychometric properties. J Pain. 2013 Aug;14(8):818-27. doi: 10.1016/j.jpain.2013.02.008. Epub 2013 May 4."}]}, 'descriptionModule': {'briefSummary': 'The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric properties of the modified Neurophysiology of Pain Questionnaire with a few word differences from the original version by conducting a rash analysis on 300 patients with chronic spinal pain. Acceptable internal consistency and test-retest reliability of the questionnaire were recorded. However, it was stated that 7 items negatively affect psychometric properties of the questionnaire. As a result, the author concluded that the questionnaire had sufficient psychometric properties for use in chronic spinal pain subjects, but further studies were needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain in different studies. The validity and reliability studies of the Dutch, French and Brazlian Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the literature. The aim of our study was to translate the Revised Neurophysiology of Pain Questionnaire into Turkish language and to investigate its psychometric properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic spinal pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with spinal pain lasting more than three months\n* Patients who older than 18 years of age\n* Patients who can understand and read Turkish.\n\nExclusion Criteria:\n\n* Patients with specific spinal pain such as trauma, fracture, infection, inflammatory disease and tumor\n* Patients who have undergone spinal surgery in the last 3 months\n* Patients who have received pain neurophysiology education in the last year.'}, 'identificationModule': {'nctId': 'NCT04099160', 'briefTitle': 'Turkish Version of Revised Neurophysiology of Pain Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Cross-cultural Adaptation of Revised Neurophysiology of Pain Questionnaire Into Turkish Language', 'orgStudyIdInfo': {'id': '34878437-199-E.115170'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Evaluation', 'type': 'OTHER', 'description': 'The Turkish version of the Revised Neurophysiology of Pain Questionnaire will be applied to patients with chronic spinal pain at the beginning of the study and a week later. The Visual Analogue Scale and the Short Form-36 (SF-36) questionnaire will be applied to patients only at the beginning of the stuy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University Department of phyiotherapy', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University Medical Ethics Committe', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Hatice Gül, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data obtained from patients at the beginning and a week later will be analyzed with SPSS program.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hatice Gül', 'investigatorAffiliation': 'Akdeniz University'}}}}