Vitamin D Level and Pain Type in Coccygodynia

NCT05047393 | Unknown

• 1 other identifier: 2021-06/21
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Coccyx Disorder; Neuropathic Pain; Nociceptive Pain; Vitamin D Deficiency

Keywords

Coccyx; Nociceptive Pain; Neuropathic Pain; Chronic pain; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

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

Coccygodynia group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with coccygodynia
• years old
• Having a vitamin D level determined
• Agreement to take part in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Emel Guler

Sivas, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 28857474 BACKGROUND

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be obtained from the patients. Vitamin D level will be determined from blood samples.

MeSH Terms

Conditions

Neuralgia; Nociceptive Pain; Vitamin D Deficiency; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Emel Güler, MD

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emel Güler, MD

CONTACT

+905356492951; dremelguler@gmail.com

Hanzade Ünal-Artık, MD

CONTACT

+905057179039; hanzadeunal@windowslive.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 17, 2021
• Study Start: August 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)