Neuropathic Spinal Pain in Ankylosing Spondylitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-06

Study Completion Date

2025-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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AS patients

AS patients diagnosed according to the modified New York criteria

Questionnaires and inventories

Intervention Type OTHER

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

Control

Age- and sex-matched control subjects with nociceptive/mechanical pain complaint lasting more than three months

Questionnaires and inventories

Intervention Type OTHER

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

Interventions

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Questionnaires and inventories

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

Intervention Type OTHER

Other Intervention Names

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physical examination

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No