Clinical trial NCT05096767: Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis
Official title: Descriptors of Neuropathic Spinal Pain and Their Relations With Functional Status in Ankylosing Spondylitis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AS patients suffering from spinal pain with severity of 3 or more on 10 cm VAS

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

Eligibility criteria: 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

Primary outcomes:
measure: Neuropathic pain
timeFrame: Once, at baseline
measure: Neuropathic pain descriptors
timeFrame: Once, at baseline
Secondary outcomes:
measure: Functional status
timeFrame: Once, at baseline
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Reseach Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Reseach Hospital
name: Taciser Kaya, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Bidad K, Gracey E, Hemington KS, Mapplebeck JCS, Davis KD, Inman RD. Pain in ankylosing spondylitis: a neuro-immune collaboration. Nat Rev Rheumatol. 2017 Jul;13(7):410-420. doi: 10.1038/nrrheum.2017.92. Epub 2017 Jun 15.
citation: Heraughty M, Ridehalgh C. Sensory descriptors which identify neuropathic pain mechanisms in low back pain: a systematic review. Curr Med Res Opin. 2020 Oct;36(10):1695-1706. doi: 10.1080/03007995.2020.1790349. Epub 2020 Aug 4.
citation: Ji Y, He Y, Nian X, Sun E, Li L. Inflammatory or Neuropathic Pain: Characteristics and Their Relationships with Disease Activity and Functional Status in Axial Spondyloarthritis Patients. Pain Med. 2019 May 1;20(5):882-888. doi: 10.1093/pm/pny138.