Neuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis

NCT06430918 · tracked via the Priya Life Science Turkey tracker

Sponsor

Bozyaka Training and Research Hospital

Phase

Observational

Started

2024-05-16

Last updated

2025-11-14

Condition(s) studied

Knee OsteoarthritisSleep DisturbanceNeuropathic Pain

Investigational drug(s) / intervention(s)

physical examination, questionnaires and inventories

physical examination, questionnaires and inventories: Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Study summary

The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1\. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent \- Exclusion Criteria: Exclusion Criteria: 1\. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months. \-

Primary outcome measure(s)

Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire — through study completion, an average of 1 year
The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value.

Trial sites (1)

Facility	City	Region	Status
Izmir Bozyaka Training and Reseach Hospital	Izmir	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06430918 on ClinicalTrials.gov ↗ ← All trials in Turkey