Clinical trial NCT04809168: Neuropathic Spinal Pain in Ankylosing Spondylitis
Official title: Prevalence of Spinal Neuropathic Pain in Ankylosing Spondylitis Patients and it's Impact on Sleep Quality: a Case-control Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ankylosing Spondylitis
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropathic pain
timeFrame: Once, at baseline
measure: Sleep quality
timeFrame: Once, at baseline
Secondary outcomes:
measure: Health related quality of life
timeFrame: Once, at baseline
measure: Fatigue
timeFrame: Once, at baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Reseach Hospital
name: Taciser Kaya
role: STUDY_DIRECTOR
References:
citation: Aydin E, Bayraktar K, Turan Y, Omurlu I, Tastaban E, Sendur OF. [Sleep quality in patients with ankylosing spondylitis]. Rev Bras Reumatol. 2015 Jul-Aug;55(4):340-5. doi: 10.1016/j.rbr.2014.12.007. Epub 2015 Feb 9. Portuguese.
citation: Geler-Kulcu D, Batibay S, Ozturk G, Mesci N. The association of neuropathic pain and disease activity, functional level, and quality of life in patients with ankylosing spondylitis: a cross-sectional study. Turk J Med Sci. 2018 Apr 30;48(2):257-265. doi: 10.3906/sag-1707-147.
citation: Choi JH, Lee SH, Kim HR, Lee KA. Association of neuropathic-like pain characteristics with clinical and radiographic features in patients with ankylosing spondylitis. Clin Rheumatol. 2018 Nov;37(11):3077-3086. doi: 10.1007/s10067-018-4125-z. Epub 2018 Apr 30.
citation: Wu Q, Inman RD, Davis KD. Neuropathic pain in ankylosing spondylitis: a psychophysics and brain imaging study. Arthritis Rheum. 2013 Jun;65(6):1494-503. doi: 10.1002/art.37920.
citation: Li Y, Zhang S, Zhu J, Du X, Huang F. Sleep disturbances are associated with increased pain, disease activity, depression, and anxiety in ankylosing spondylitis: a case-control study. Arthritis Res Ther. 2012 Oct 11;14(5):R215. doi: 10.1186/ar4054.