Assessment of Peripheral Neuropathy in Ankylosing Spondylitis

June 10, 2026 updated by: Sara Farrag Ahmed Mohamed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 711111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥18 years with Diagnosis of ankylosing spondylitis according to the modified New York criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Nerve conduction study
Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sara Farrag, Lecturer, Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankylosing.6.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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