Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

May 10, 2026 updated by: Taciser Kaya, Bozyaka Training and Research Hospital

Descriptors of Neuropathic Spinal Pain and Their Relations With Functional Status in Ankylosing Spondylitis Patients

The investigators have aimed to explore and interpret the neuropathic pain (NP) descriptors of spinal pain in patients with ankylosing spondylitis (AS). For this purpose they have attempted to initiate a prospective, cross-sectional study with AS patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

NP descriptors have been investigated in several pain syndromes such as post-herpetic neuralgia, post-surgical nerve trauma, peripheral diabetic neuropathy and low back pain. But there is no study examining descriptors of inflammatory spinal pain with or without neuropathic characteristics seen in AS. To date, only one study reported distribution of sensory descriptors in neuropathic and non-neuropathic pain (nonNP) in AS patients, but in this paper the painful region was not specified and the results related to sensory descriptors were not discussed. Therefore, investigators have aimed to explore and interpret the sensory descriptors of inflammatory spinal pain in patients with AS. For this purpose investigators have attempted to initiate a study investigating whether sensory descriptors in neuropathic pain (NP) are differ from those seen in non-neuropathic pain (nonNP).

The aims of this study are;

  1. To determine NP descriptors that associated with spinal pain in ankylosing spondylitis patients
  2. To compare the patients with and without NP with respect to sensory descriptors
  3. To evaluate the relation between neuropathic pain (NP) descriptors and functional status

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35300
        • Izmir Bozyaka Training and Reseach Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

AS patients suffering from spinal pain with severity of 3 or more on 10 cm VAS

Description

Inclusion Criteria:

  • Being diagnosed with AS according to the Modified NewYork Criteria
  • Visual Analogue Scale spinal pain score ≥ 3

Exclusion Criteria:

  1. Diabetes mellitus, renal insufficiency, hypothyroidism
  2. Postherpetic neuralgia, spinal cord compression
  3. Being diagnosed as fibromyalgia in the last month or widespread pain indicating fibromyalgia
  4. Malignancy
  5. Pregnancy
  6. Severe cardiac disease
  7. In the last three months medical treatment leading to neuropathy (colchicine etc.)
  8. In the last three months drug use for the treatment of fibromyalgia, depression or anxiety

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic pain
Time Frame: Once, at baseline
It will be assessed using the painDETECT questionnaire. This questionnaire, contains nine questions all of which are selfreport. Seven items are rated on a six point Likert scale and thus are scored between 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness etc. Apart from these seven items, one item assesses the radiation of pain and the other one item looks for the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means possible neuropathic component and 19 or greater means a neuropathic component is likely. Beside these, there are three items in a separate section measuring severity of pain at the time of evaluation, on average and maximum over the past month. This section is not taken into account in scoring.
Once, at baseline
Neuropathic pain descriptors
Time Frame: Once, at baseline
In the painDETECT questionnaire, seven items querying sensory abnormalities are scored between 0-5. Each of these abnormal sensations represent a pain descriptor. These descriptors are; burning, tingling, allodynia, pain attacks, thermal hyperalgesia, numbness and pressure hyperalgesia. A descriptor will accepted as positive if it is scored between 3 to 5
Once, at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: Once, at baseline
To measure functional status of patients, Bath Ankylosing Spondylitis Functional Index will be used. It is a 10 item questionnaire querying patients' ability in performing daily activities (such as dressing, bending forward, climbing stairs, reaching a shelf, etc.) on a line of 10 centimeters. The final score is the average of the items, between 0 (no limitation) to 10 (maximal limitation in function).
Once, at baseline

Collaborators and Investigators

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

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Taciser Kaya, Prof., MD, Izmir Bozyaka Training and Reseach Hospital

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 (Actual)

October 15, 2021

Primary Completion (Estimated)

May 5, 2027

Study Completion (Estimated)

May 5, 2027

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 355148EA

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

product manufactured in and exported from the U.S.

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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