- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07641920
Assessment of Peripheral Neuropathy in Ankylosing Spondylitis
Assessment of Peripheral Neuropathy in Ankylosing Spondylitis and Its Correlation With, Central Sensitization, Disease Activity and Quality of Life
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the axial skeleton, leading to persistent back pain, stiffness, and progressive functional impairment.
Pain in AS has been attributed to inflammation; however, accumulating evidence suggests that non-inflammatory mechanisms, including neuropathic pain and central sensitization, play a significant role in the overall pain experience.
Previous studies using screening tools such as Pain DETECT and S LANSS(Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaires have reported that a considerable proportion of patients exhibit neuropathic pain features, with prevalence ranging from approximately 28% to over 50%. Moreover, neuropathic pain has been associated with higher disease activity scores, worse functional status, and impaired quality of life.
In addition, central sensitization defined as an amplification of neural signaling within the central nervous system has been proposed as a key contributor to chronic pain in AS. Neuroimaging and psychophysical studies have demonstrated alterations in brain structure and pain processing in AS patients, supporting the presence of central pain mechanisms.
Peripheral neuropathy may also occur in AS, potentially due to chronic inflammation, immune-mediated pathways, or mechanical and treatment-related factors. Electrophysiological evaluation using nerve conduction studies (NCS) provides an objective method for detecting large-fiber neuropathy and has revealed peripheral nervous system involvement in a subset of AS patients.
Disease activity in AS is commonly assessed using the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), while disease-specific quality of life can be evaluated using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Understanding the interaction between inflammatory activity, neuropathic pain, and central sensitization is essential for optimizing patient management.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-post: sara_farrag@aun.edu.eg
Studieorter
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypten, 711111
- Assiut University
-
Kontakt:
- Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-post: sara_farrag@aun.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients aged ≥18 years
- Diagnosis of ankylosing spondylitis according to the modified New York criteria (6).
- Ability to provide informed consent
Exclusion Criteria:
- Patients under the age of 18 years.
- Patients with definite diagnosis for any other systemic autoimmune disorders.
- Diabetes mellitus
- Chronic renal or hepatic disease
- Alcohol abuse or drug-induced neuropathy
- Known neurological disorders affecting peripheral nerves
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Ankylosing spondylitis Patients
Quality of Life Assessment By Ankylosing Spondylitis Quality of Life Questionnaire and Assessment of Peripheral Neuropathy using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
|
Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
presence of peripheral neuropathy
Tidsram: 1 month
|
Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
|
1 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sara Farrag, Lecturer, Assiut University
Publikationer och användbara länkar
Allmänna publikationer
- Wu Q, Inman RD, Davis KD. Neuropathic pain in ankylosing spondylitis: a psychophysics and brain imaging study. Arthritis Rheum. 2013 Jun;65(6):1494-503. doi: 10.1002/art.37920.
- Atik S, Sahin O, Atik I, Polat M. Neuropathic Pain Component in Patients with Ankylosing Spondylitis and the Relationship of Neuropathic Pain and Disease Activity Parameters: A Cross-Sectional Study. J Musculoskelet Neuronal Interact. 2024 Sep 1;24(3):284-290.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Axial spondyloartrit
- Skelettsjukdomar
- Muskuloskeletala sjukdomar
- Sjukdomar i nervsystemet
- Neuromuskulära sjukdomar
- Artrit
- Ledsjukdomar
- Spinal sjukdomar
- Spondylarthropatier
- Ankylos
- Spondylartrit
- Spondylit
- Spondylit, ankyloserande
- Sjukdomar i det perifera nervsystemet
- Diagnostiska tekniker och procedurer
- Diagnos
- Diagnostiska tekniker, neurologiska
- Elektrodiagnos
- Nervledningsstudier
Andra studie-ID-nummer
- Ankylosing.6.2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .