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临床试验/NCT05096767
NCT05096767进行中(未招募)不适用

Descriptors of Neuropathic Spinal Pain and Their Relations With Functional Status in Ankylosing Spondylitis Patients

Bozyaka Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 130 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
130
试验地点
2
主要终点
Neuropathic pain descriptors

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with AS according to the Modified NewYork Criteria
  • Visual Analogue Scale spinal pain score ≥ 3

排除标准

  • Diabetes mellitus, renal insufficiency, hypothyroidism
  • Postherpetic neuralgia, spinal cord compression
  • Being diagnosed as fibromyalgia in the last month or widespread pain indicating fibromyalgia
  • Severe cardiac disease
  • 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 or anxiety

结局指标

主要结局

Neuropathic pain descriptors

时间窗: 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

时间窗: 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.

次要结局

  • Functional status(Once, at baseline)

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taciser Kaya

Professor, MD

Bozyaka Training and Research Hospital

研究点 (2)

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