Vitamin D Level and Pain Type in Coccygodynia

Sponsor

Cumhuriyet University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05047393

Collaborator

(none)

Enrollment

Location

6.9

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coccyx Disorder Neuropathic Pain Nociceptive Pain Vitamin D Deficiency	Other: Current blood vitamin D level and painDetect questionairre score will be detected

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Vitamin D Level on Pain Type in Coccygodynia

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Coccygodynia group 51 patients with a diagnosis of coccygodynia will be included in the study.	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.

Arm

Intervention/Treatment

Coccygodynia group

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

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.

Outcome Measures

Primary Outcome Measures

Neuropathic pain in coccygodynia [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.
Vitamin D level in coccygodynia [The study will be completed in 7 months.]
Vitamin D level of the patients registered in the hospital system will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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