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NCT Number: NCT07641920

Assessment of Peripheral Neuropathy in Ankylosing Spondylitis

investigators hypothesized that peripheral neuropathy in ankylosing spondylitis is associated with higher disease activity, greater central sensitization, worse functional impairment, and poorer quality of life.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve Conduction Study

Diagnostic Test

Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.

Primary outcomes

  1. presence of peripheral neuropathy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Farrag, Lecturer

CONTACT

[email protected]

+201097767735

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Peripheral Neuropathy in Ankylosing Spondylitis and Its Correlation With, Central Sensitization, Disease Activity and Quality of Life

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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