- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-mail: sara_farrag@aun.edu.eg
Studiesteder
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Asyut Governorate
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Asyut, Asyut Governorate, Egypten, 711111
- Assiut University
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Kontakt:
- Sara Farrag, Lecturer
- Telefonnummer: +201097767735
- E-mail: sara_farrag@aun.edu.eg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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presence of peripheral neuropathy
Tidsramme: 1 month
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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.
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1 month
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sara Farrag, Lecturer, Assiut University
Publikationer og nyttige links
Generelle 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Aksial spondyloarthritis
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Neuromuskulære sygdomme
- Gigt
- Ledsygdomme
- Rygmarvssygdomme
- Spondylarthropatier
- Ankylose
- Spondylarthritis
- Spondylitis
- Spondylitis, ankyloserende
- Sygdomme i det perifere nervesystem
- Diagnostiske teknikker og procedurer
- Diagnose
- Diagnostiske teknikker, neurologisk
- Elektrodiagnose
- Nerve ledningsundersøgelser
Andre undersøgelses-id-numre
- Ankylosing.6.2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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