Ankylosing SpondylitisNCT07641920
Assessment of Peripheral Neuropathy in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Peripheral Neuropathies, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Peripheral Neuropathies
- What is being tested?
- Nerve conduction study
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years with Diagnosis of ankylosing spondylitis according to the modified New York criteria
Who may be able to join
- Patients aged ≥18 years
- Diagnosis of ankylosing spondylitis according to the modified New York criteria (6).
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut, Asyut Governorate, 711111
Sara Farrag, Lecturer, +201097767735, sara_farrag@aun.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankylosing Spondylitis, Peripheral Neuropathies
- Being tested
- Nerve conduction study
- Keywords
- Ankylosing Spondylitis, Quality of Life, Peripheral Neuropathy
- Medical subject headings
- Spondylitis, Ankylosing, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studyDiagnostic test
Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nerve conduction study |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of peripheral neuropathy
Peripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Farrag Ahmed Mohamed, Assiut University
- Investigators
- Sara Farrag, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641920
- Sponsor's protocol ID
- Ankylosing.6.2026
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39219326Wu 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.
PubMed 23460087
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peripheral Neuropathy in Ankylosing Spondylitis and Its Correlation With, Central Sensitization, Disease Activity and Quality of Life
- ClinicalTrials.gov ID
- NCT07641920
- Acronym / sponsor ID
- Ankylosing.6.2026
- Conditions
- Ankylosing Spondylitis, Peripheral Neuropathies
- Keywords
- Ankylosing Spondylitis, Quality of Life, Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankylosing spondylitis Patients | – | Diagnostic Test: Nerve conduction studyQuality 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years with Diagnosis of ankylosing spondylitis according to the modified New York criteria
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- Diagnosis of ankylosing spondylitis according to the modified New York criteria (6).
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve conduction studyPeripheral neuropathy will be evaluated using nerve conduction studies (NCS) for upper and lower limbs peripheral nerves performed according to standard electrophysiological techniques. | Diagnostic test | Ankylosing spondylitis Patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 39219326Atik 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.
- Background: PubMed 23460087Wu 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.
- Individual participant dataSharing planned: No
Related trials for Ankylosing Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Farrag, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Peripheral Neuropathies, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Farrag, Lecturer (+201097767735, sara_farrag@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of peripheral neuropathy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.