Vitamin D Level and Pain Type in Coccygodynia

NCT ID: NCT05047393

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Coccyx Disorder Neuropathic Pain Nociceptive Pain Vitamin D Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coccygodynia group

51 patients with a diagnosis of coccygodynia will be included in the study.

Current blood vitamin D level and painDetect questionairre score will be detected

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

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Emel Güler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emel Güler, MD

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

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Emel Guler

Sivas, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emel Güler, MD

Role: CONTACT

+905356492951

Hanzade Ünal-Artık, MD

Role: CONTACT

+905057179039

Facility Contacts

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emel guler

Role: primary

+905356492951

References

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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.

Reference Type BACKGROUND
PMID: 28857474 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/28857474/

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

Other Identifiers

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2021-06/21

Identifier Type: -

Identifier Source: org_study_id

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