Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05096767
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2021-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropathic pain', 'timeFrame': 'Once, at baseline', 'description': 'It will be assessed using the painDETECT questionnaire. This questionnaire, contains nine questions all of which are selfreport. Seven items are rated on a six point Likert scale and thus are scored between 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness etc. Apart from these seven items, one item assesses the radiation of pain and the other one item looks for the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means possible neuropathic component and 19 or greater means a neuropathic component is likely. Beside these, there are three items in a separate section measuring severity of pain at the time of evaluation, on average and maximum over the past month. This section is not taken into account in scoring.'}, {'measure': 'Neuropathic pain descriptors', 'timeFrame': 'Once, at baseline', 'description': 'In the painDETECT questionnaire, seven items querying sensory abnormalities are scored between 0-5. Each of these abnormal sensations represent a pain descriptor. These descriptors are; burning, tingling, allodynia, pain attacks, thermal hyperalgesia, numbness and pressure hyperalgesia. A descriptor will accepted as positive if it is scored between 3 to 5'}], 'secondaryOutcomes': [{'measure': 'Functional status', 'timeFrame': 'Once, at baseline', 'description': "To measure functional status of patients, Bath Ankylosing Spondylitis Functional Index will be used. It is a 10 item questionnaire querying patients' ability in performing daily activities (such as dressing, bending forward, climbing stairs, reaching a shelf, etc.) on a line of 10 centimeters. The final score is the average of the items, between 0 (no limitation) to 10 (maximal limitation in function)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '29713968', 'type': 'BACKGROUND', 'citation': 'Choi JH, Lee SH, Kim HR, Lee KA. Association of neuropathic-like pain characteristics with clinical and radiographic features in patients with ankylosing spondylitis. Clin Rheumatol. 2018 Nov;37(11):3077-3086. doi: 10.1007/s10067-018-4125-z. Epub 2018 Apr 30.'}, {'pmid': '28615730', 'type': 'BACKGROUND', 'citation': 'Bidad K, Gracey E, Hemington KS, Mapplebeck JCS, Davis KD, Inman RD. Pain in ankylosing spondylitis: a neuro-immune collaboration. Nat Rev Rheumatol. 2017 Jul;13(7):410-420. doi: 10.1038/nrrheum.2017.92. Epub 2017 Jun 15.'}, {'pmid': '32609541', 'type': 'BACKGROUND', 'citation': 'Heraughty M, Ridehalgh C. Sensory descriptors which identify neuropathic pain mechanisms in low back pain: a systematic review. Curr Med Res Opin. 2020 Oct;36(10):1695-1706. doi: 10.1080/03007995.2020.1790349. Epub 2020 Aug 4.'}, {'pmid': '30020521', 'type': 'BACKGROUND', 'citation': 'Ji Y, He Y, Nian X, Sun E, Li L. Inflammatory or Neuropathic Pain: Characteristics and Their Relationships with Disease Activity and Functional Status in Axial Spondyloarthritis Patients. Pain Med. 2019 May 1;20(5):882-888. doi: 10.1093/pm/pny138.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have aimed to explore and interpret the neuropathic pain (NP) descriptors of spinal pain in patients with ankylosing spondylitis (AS). For this purpose they have attempted to initiate a prospective, cross-sectional study with AS patients.', 'detailedDescription': 'NP descriptors have been investigated in several pain syndromes such as post-herpetic neuralgia, post-surgical nerve trauma, peripheral diabetic neuropathy and low back pain. But there is no study examining descriptors of inflammatory spinal pain with or without neuropathic characteristics seen in AS. To date, only one study reported distribution of sensory descriptors in neuropathic and non-neuropathic pain (nonNP) in AS patients, but in this paper the painful region was not specified and the results related to sensory descriptors were not discussed. Therefore, investigators have aimed to explore and interpret the sensory descriptors of inflammatory spinal pain in patients with AS. For this purpose investigators have attempted to initiate a study investigating whether sensory descriptors in neuropathic pain (NP) are differ from those seen in non-neuropathic pain (nonNP).\n\nThe aims of this study are;\n\n1. To determine NP descriptors that associated with spinal pain in ankylosing spondylitis patients\n2. To compare the patients with and without NP with respect to sensory descriptors\n3. To evaluate the relation between neuropathic pain (NP) descriptors and functional status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AS patients suffering from spinal pain with severity of 3 or more on 10 cm VAS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with AS according to the Modified NewYork Criteria\n* Visual Analogue Scale spinal pain score ≥ 3\n\nExclusion Criteria:\n\n1. Diabetes mellitus, renal insufficiency, hypothyroidism\n2. Postherpetic neuralgia, spinal cord compression\n3. Being diagnosed as fibromyalgia in the last month or widespread pain indicating fibromyalgia\n4. Malignancy\n5. Pregnancy\n6. Severe cardiac disease\n7. In the last three months medical treatment leading to neuropathy (colchicine etc.)\n8. In the last three months drug use for the treatment of fibromyalgia, depression or anxiety'}, 'identificationModule': {'nctId': 'NCT05096767', 'briefTitle': 'Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Descriptors of Neuropathic Spinal Pain and Their Relations With Functional Status in Ankylosing Spondylitis Patients', 'orgStudyIdInfo': {'id': '355148EA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaires and inventories', 'type': 'OTHER', 'description': 'questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35300', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Taciser Kaya, Prof., MD', 'role': 'CONTACT', 'email': 'taciserkaya@gmail.com', 'phone': '+905323948990'}, {'name': 'Seda Soma, Trainee, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Izmir Bozyaka Training and Reseach Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Taciser Kaya, Prof., MD', 'role': 'CONTACT', 'email': 'taciserkaya@gmail.com', 'phone': '+905323948990'}], 'overallOfficials': [{'name': 'Taciser Kaya, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Bozyaka Training and Reseach Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozyaka Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Taciser Kaya', 'investigatorAffiliation': 'Bozyaka Training and Research Hospital'}}}}