Vitamin D Level and Pain Type in Coccygodynia

Effect of Vitamin D Level on Pain Type in Coccygodynia

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

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Neuropathic Pain; Nociceptive Pain; Coccyx Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 51

Contacts and Locations

• Study Contact: Name: Hanzade Ünal-Artık, MD; Phone Number: +905057179039; Email: hanzadeunal@windowslive.com

Study Locations

• Turkey
  • Sivas, Turkey
    • Recruiting
    • Emel Guler
    • Contact: emel guler; Phone Number: +905356492951; Email: emelguler@cumhuriyet.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to Sivas Cumhuriyet University Faculty of Medicine Physical Therapy and Rehabilitation clinic between 01/08/2021 and 28/02/2022 and were diagnosed with coccygodynia and had their vitamin D levels checked will be included in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Chronic pain; Vitamin D Deficiency; Neuropathic Pain; Nociceptive Pain; Coccyx
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Diseases; Peripheral Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Neuralgia; Vitamin D Deficiency; Nociceptive Pain; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2021-06/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No