Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

Recruiting

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT05096767
• Lead Sponsor: Bozyaka Training and Research Hospital

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

Study Timeline

• Study First Submitted: 2021-10-12
• Study Start: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-11-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Izmir Bozyaka Training and Reseach Hospital; 🇹🇷 Izmir, Turkey