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临床试验/NCT05047393
NCT05047393Unknown不适用

Effect of Vitamin D Level on Pain Type in Coccygodynia

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
51
试验地点
1
主要终点
Vitamin D level in coccygodynia

研究概览

简要总结

Coccygodynia is a painful clinical picture of the sacrococcygeal region.Pain in coccygodynia may be somatic, neuropathic or mixed. There are many studies that emphasize the relationship between vitamin D deficiency and pain.In this study, it is aimed to investigate the severity and type of pain, as well as the effect of vitamin D level on pain in patients with coccygodynia

详细描述

There are different types of pain in coccygodynia. Patients may suffer from e somatic, neuropathic or mixed pain.Vitamin D plays an important role in the pathophysiology of pain. Vitamin D inhibits NO synthase (iNOS) in microglia and astrocytes. The importance of this is that nitric oxide (NO) is an important molecule in the development of neuropathic pain. NO production contributes to the maintenance of pain hypersensitivity. NO causes central sensitization and mechanical allodynia by increasing spinal cord posterior horn N-methyl-D-aspartate (NMDA) receptors.In the literature, it has been reported that low vitamin D level is associated with the severity of neuropathic pain in postherpetic neuralgia, diabetic neuropathy, rheumatoid arthritis and carpal tunnel syndrome, which cause neuropathic pain development.

Based on the above-mentioned data, in this study, I aimed to investigate the severity and type of pain, as well as the effect of vitamin D level on pain in patients with coccygodynia. Within the scope of the study, 51 patients with a diagnosis of coccygodynia will be recruited. Patients' age, gender, body mass index, duration of symptoms, etiology of coccycodynia, pain severity, pain type and blood vitamin D level will be recorded. Pain assessment (for discrimination between nociceptive, mixed and neuropathic pain) will be done with the painDETECT questionairre. Pain severity will be evaluated with Visual Analog Scale (VAS). Those with vitamin D levels < 20 ng/mL, 20-30 ng/mL, and ˃30 ng/mL will be grouped as deficiency, insufficiency and normal, respectively.The data will be entered into the SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for normally distributed data, and non-parametric tests will be used for data not normally distributed. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P<0.05 will be considered significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Diagnosed with coccygodynia
  • 18-70 years old
  • Having a vitamin D level determined
  • Agreement to take part in the study.

排除标准

  • Presence of known polyneuropathy,
  • Presence of diabetes mellitus, renal failure, thyroid diseases
  • Taking vitamin D replacement therapy,
  • Using any of the medications used in the treatment of neuropathic pain such as duloxetine, pregabalin, gabapentin and tramadol, Having undergone an interventional procedure for coccygodynia within 3 months before the evaluation

结局指标

主要结局

Vitamin D level in coccygodynia

时间窗: The study will be completed in 7 months.

Vitamin D level of the patients registered in the hospital system will be recorded.

Neuropathic pain in coccygodynia

时间窗: The study will be completed in 7 months.

PainDETECT neuropathic pain questionnaire will be used to evaluate the presence of neuropathic pain in patients.The questionnaire score ranges from 0-35 points, and a score of 19 and above indicates the presence of neuropathic pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Güler

Associate Professor

Cumhuriyet University

研究点 (1)

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