Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05096767

Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Bozyaka Training and Reseach Hospital

Izmir, 35300, Turkey (Türkiye)

About this study

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;

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

questionnaires and inventories

Other

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2021
Registry last updated
May 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.