Vitamin D Level and Pain Type in Coccygodynia
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| ClinicalTrials.gov Identifier: NCT05047393 |
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Recruitment Status :
Recruiting
First Posted : September 17, 2021
Last Update Posted : September 27, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Coccyx Disorder Neuropathic Pain Nociceptive Pain Vitamin D Deficiency | Other: Current blood vitamin D level and painDetect questionairre score will be detected |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 51 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Effect of Vitamin D Level on Pain Type in Coccygodynia |
| Actual Study Start Date : | August 1, 2021 |
| Estimated Primary Completion Date : | February 28, 2022 |
| Estimated Study Completion Date : | February 28, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Coccygodynia group
51 patients with a diagnosis of coccygodynia will be included in the study.
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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. |
- Neuropathic pain in coccygodynia [ Time Frame: 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 [ Time Frame: The study will be completed in 7 months. ]Vitamin D level of the patients registered in the hospital system will be recorded.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047393
| Contact: Emel Güler, MD | +905356492951 | dremelguler@gmail.com | |
| Contact: Hanzade Ünal-Artık, MD | +905057179039 | hanzadeunal@windowslive.com |
| Turkey | |
| Emel Guler | Recruiting |
| Sivas, Turkey | |
| Contact: emel guler +905356492951 emelguler@cumhuriyet.edu.tr | |
| Principal Investigator: | Emel Güler, MD | Cumhuriyet University |
Publications:
| Responsible Party: | Emel Güler, Associate Professor, Cumhuriyet University |
| ClinicalTrials.gov Identifier: | NCT05047393 |
| Other Study ID Numbers: |
2021-06/21 |
| First Posted: | September 17, 2021 Key Record Dates |
| Last Update Posted: | September 27, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Coccyx Nociceptive Pain Neuropathic Pain Chronic pain Vitamin D Deficiency |
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Neuralgia Vitamin D Deficiency Nociceptive Pain Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |