Neuropathic Spinal Pain in Ankylosing Spondylitis

November 24, 2023 updated by: Taciser Kaya, Bozyaka Training and Research Hospital

Prevalence of Spinal Neuropathic Pain in Ankylosing Spondylitis Patients and it's Impact on Sleep Quality: a Case-control Study

The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease that mainly presenting with chronic back pain. In general, chronic low back pain is currently defined as a mixed pain including nociceptive and neuropathic properties. Nociceptive pain in several rheumatic diseases displays neuropathic characteristics over time. Patients with AS are suffered from spinal, entheseal pain or pain originated from peripheral and root joints. Although being scarce, there are trials investigating and reporting neuropathic component of spinal pain in axial spondyloarthritis/ankylosing spondylitis patients. However these trials either are not controlled or did not specify painful region of interest. In a few controlled trials control subjects were not defined clearly.

Sleep problems are reported to be prevalent among patients with chronic pain conditions such as inflammatory rheumatic diseases and fibromyalgia. In patients with ankylosing spondylitis sleep disturbance is a well defined issue. The fact that sleep problem is a common problem in AS, raises the need to explore it's associates. In the trials measuring spinal neuropathic pain, sleep disturbances and it's association with neuropathic pain were not assessed.

So, investigators have aimed to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. For this purpose a case-control study design was planned. Age- and sex-matched control subjects will be chosen among individuals submitted to out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months. Participants in control group will be subjected to same exclusion criteria too.

This design will allow the investigators to determine whether spinal pain in AS patients displays neuropathic character more frequently than any chronic nociceptive pain does.

Study Type

Observational

Enrollment (Actual)

292

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
      • İzmir, Turkey
        • Izmir Bozyaka Training and Research 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 and age- and sex-matched control subjects will be chosen among individuals submitting to our out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months.

Description

Inclusion Criteria:

  • Being diagnosed with AS according to the 1984 Modified New York Criteria
  • Visual Analogue Scale (VAS) spinal pain score ≥ 2

Exclusion Criteria:

  • Diabetes mellitus, renal insufficiency, hypothyroidism
  • Carpal tunnel syndrome, postherpetic neuralgia, spinal cord compression
  • Neurological diseases leading to neuropathic pain
  • Cervical and lumbar radiculopathy
  • Fibromyalgia
  • Malignancy
  • Severe cardiac disease
  • Pregnancy
  • Muscle weakness or hypoesthesia indicating peripheral nerve injury
  • 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 and 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AS patients
AS patients diagnosed according to the modified New York criteria
Other: Questionnaires and inventories
questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Other Names:
  • physical examination
Control
Age- and sex-matched control subjects with nociceptive/mechanical pain complaint lasting more than three months
Other: Questionnaires and inventories
questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Other Names:
  • physical examination

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 self-report. 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
Sleep quality
Time Frame: Once, at baseline
It will be assessed using Pittsburgh Sleep Quality Index (PSQI). It was developed by Buysse and coworkers in 1989. This index measures sleep quality quantitatively and covers 24 questions. Nineteen questions are self-rated and scoring is based on these self-rated questions, other five questions that rating by partner are not taken into account while calculating total score. Questionnaire measures seven domains; subjective sleep quality (question 6), sleep latency (question 2 and 5a), sleep duration (question 4), habitual sleep efficiency (question 1,3,4), sleep disturbances (question 5b-j), use of sleep medication (question 7), and daytime dysfunction (question 8 and 9) over the last month. Seven domain scores give a result on a 0 to 3 scale. To yield a total score the domain scores are summed. Total score varies between 0 and 21. Higher scores indicate worse sleep quality.
Once, at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: Once, at baseline
Health related quality of life will be assessed using (Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) querying symptoms, functioning, and disease-related concern. It covers 18 dichotomous questions that ask participants to answer in a yes or no fashion. An answer of "yes" is assumed as one point. To get a final score, all points are summed. Thus, total score is between 0-18 and higher scores indicate worse quality of life.
Once, at baseline
Fatigue
Time Frame: Once, at baseline
It will be assessed using Fatigue Severity Scale. This scale contains nine questions and measures fatigue severity during the past week. Each question is rated between 1 (strongly disagree)-7 (strongly disagree). Total score is mean of all To calculate total score first the points of all answers are summed and then the result is divided by nine. Higher scores indicate severe fatigue
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

  • Study Director: Taciser Kaya, 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)

April 6, 2021

Primary Completion (Estimated)

November 2, 2024

Study Completion (Estimated)

November 2, 2024

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46418926TK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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