Vitamin D Level and Pain Type in Coccygodynia

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Vitamin D Level on Pain Type in Coccygodynia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047393
• Other study ID #: 2021-06/21
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2021
• Source: Sivas Cumhuriyet University
• Contact: Emel Güler, MD
• Phone: +905356492951
• Email: dremelguler[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with coccygodynia

• 18-70 years old

• Having a vitamin D level determined

• Agreement to take part in the study.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Vitamin D Deficiency

Intervention

Other:
• Current blood vitamin D level and painDetect questionairre score will be detected
PainDETECT neuropathic pain questionnaire will be used to evaluate the presence of nociceptive, mixed and neuropathic pain in patients. Patients with a total questionnaire score of 12 or less are considered nociceptive pain without a neuropathic pain component. If the total score is in the range of 13-18, the result is uncertain, but it is accepted that the neuropathic component can be found in the mixed type, and in the scores of 19 and above, it is accepted that the neuropathic pain component is present. Patients with previously obtained and finalized vitamin D levels < 20 ng/mL, 20-30 ng/mL, and ?30 ng/mL will be grouped as deficiency, insufficiency and normal, respectively.

Locations

Country	Name	City	State
Turkey	Emel Guler	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Sivas Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Yesil H, Sungur U, Akdeniz S, Gurer G, Yalcin B, Dundar U. Association between serum vitamin D levels and neuropathic pain in rheumatoid arthritis patients: A cross-sectional study. Int J Rheum Dis. 2018 Feb;21(2):431-439. doi: 10.1111/1756-185X.13160. Epub 2017 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic pain in coccygodynia	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.	The study will be completed in 7 months.
Primary	Vitamin D level in coccygodynia	Vitamin D level of the patients registered in the hospital system will be recorded.	The study will be completed in 7 months.

External Links

•   Association between serum vitamin D levels and neuropathic pain in rheumatoid arthritis