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Clinical Trials/NCT05096767
NCT05096767
Recruiting
Not Applicable

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

Bozyaka Training and Research Hospital1 site in 1 country130 target enrollmentOctober 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Bozyaka Training and Research Hospital
Enrollment
130
Locations
1
Primary Endpoint
Neuropathic pain descriptors
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
December 25, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Bozyaka Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Taciser Kaya

Professor, MD

Bozyaka Training and Research Hospital

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • Functional status(Once, at baseline)

Study Sites (1)

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