- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-post: sara_farrag@aun.edu.eg
Studiesteder
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 711111
- Assiut university
-
Ta kontakt med:
- Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-post: sara_farrag@aun.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
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Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
presence of peripheral neuropathy
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sara Farrag, Lecturer, Assiut university
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Aksial spondyloartritt
- Beinsykdommer
- Muskel- og skjelettsykdommer
- Sykdommer i nervesystemet
- Nevromuskulære sykdommer
- Leddgikt
- Leddsykdommer
- Spinal sykdommer
- Spondylarthropatier
- Ankylose
- Spondylartritt
- Spondylitt
- Spondylitt, Bekhterevs
- Sykdommer i det perifere nervesystemet
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Diagnostiske teknikker, nevrologiske
- Elektrodiagnose
- Nerveledningsstudier
Andre studie-ID-numre
- Ankylosing.6.2026
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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