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Neuropathic Spinal Pain in Ankylosing Spondylitis

StatusActive, Not Recruiting
PhaseNot specified
Started2021-04-06
View on ClinicalTrials.gov ↗

Amendment history

2026-05-10
minor
Study Status, Oversight, IPDSharing v6
Completion date2025-12-02→2026-12-02
2025-05-16
minor
Study Status, Oversight, IPDSharing v5
Completion date2024-11-02→2025-12-02
2023-11-24
notable
Completed→Active, Not Recruiting Study Status v4
Trial statusCompleted→Active, Not Recruiting
Primary completion date2021-11-02→2024-11-02
Completion date2021-11-02→2024-11-02
2021-11-02
notable
Enrolling by Invitation→Completed Study Status, Study Design v3
Trial statusEnrolling by Invitation→Completed
Primary completion dateestimated 2022-04→confirmed 2021-11-02
Completion dateestimated 2022-06→confirmed 2021-11-02
Enrollment targetestimated 300→confirmed 292
2021-10-12
minor
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2021-04-10
minor
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Start dateestimated 2021-04→confirmed 2021-04-06
Eligibility criteria+25 characters
Inclusion Criteria: Being diagnosed with AS according to the 1984 Modified New York Criteria Visual Analogue Scale (VAS) spinal pain score ≥ 2 Exclusion Criteria: Diabetes mellitus [...] isease Pregnancy Muscle weakness or hypoesthesia indicating periferalperipheral nerve injury In the last three months medical treatment lea [...] drug use for the treatment of fibromyalgia, depression and anxieteanxiety
Secondary endpoints2 entries, revised
FatiqueFatigue
Study description+21 characters
[...] 's association with neuropathic pain were not assessed. So, weinvestigators have aimed to investigate prevalence of neuropathic spinal [...] x-matched control subjects will be chosen among individuals submittingsubmitted to our out-patient clinic with nociceptive/mechanical pain complai [...] cted to same exclusion criteria too. This design will allow usthe investigators to determine whether spinal pain in AS patients displays ne [...]
2021-03-19
minor
Original filing
The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.
Trial Details
NCT Number NCT04809168
Lead Sponsor Bozyaka Training and Research Hospital
Conditions Ankylosing Spondylitis
Enrollment 292 participants
Start Date 2021-04-06
Primary Completion 2024-11-02 (estimated)
Study Completion 2026-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-13