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

NCT ID: NCT06430918

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2027-07-30

Brief 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.

Detailed Description

Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder.

The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient.

Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis.

American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.

Conditions

Knee Osteoarthritis; Sleep Disturbance; Neuropathic Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with knee osteoarthritis

Knee OA patients diagnosed according to the ACR Classification Criteria

physical examination, questionnaires and inventories

Intervention Type: OTHER

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

Interventions

physical examination, questionnaires and inventories

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

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

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

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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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taciser Kaya

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taciser Kaya, Prof.

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital İzmir, Turkey

Berna Kirilmaz Colak, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital İzmir, Turkey

Bugra Ince, Assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital İzmir, Turkey

Locations

Izmir Bozyaka Training and Reseach Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085.

Reference Type: RESULT

PMID: 32365479 (View on PubMed)

Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24.

Reference Type: RESULT

PMID: 22120461 (View on PubMed)

Other Identifiers

226092BK

Identifier Type: -

Identifier Source: org_study_id