Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

Sponsor
Bozyaka Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096767
Collaborator
(none)
130
1
7.5
17.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaires and inventories

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 Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Descriptors of Neuropathic Spinal Pain and Their Relations With Functional Status in Ankylosing Spondylitis Patients
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Neuropathic pain [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 [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 Outcome Measures

  1. Functional status [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Izmir Bozyaka Training and Reseach Hospital Izmir Turkey 35300

Sponsors and Collaborators

  • Bozyaka Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taciser Kaya, Professor, MD, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05096767
Other Study ID Numbers:
  • 355148EA
First Posted:
Oct 27, 2021
Last Update Posted:
Nov 10, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2021