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

NCT06430918 | Enrolling By Invitation

• 1 other identifier: 226092BK
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Sleep Disturbance; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire

  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.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Sleep quality

  through study completion, an average of 1 year

• Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS)

  through study completion, an average of 1 year

• Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup

  through study completion, an average of 1 year

• Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup

  through study completion, an average of 1 year

• Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.

  through study completion, an average of 1 year

Study Arms (1)

Patients with knee osteoarthritis

Knee OA patients diagnosed according to the ACR Classification Criteria

Other: physical examination, questionnaires and inventories

Interventions

physical examination, questionnaires and inventories OTHER

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

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

Patients with knee osteoarthritis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Reseach Hospital

Izmir, 35300, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32365479 RESULT

• 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.

  PMID: 22120461 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Parasomnias; Neuralgia

Interventions

Restraint, Physical; Surveys and Questionnaires; Equipment and Supplies

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Taciser Kaya, Prof.

  Izmir Bozyaka Training and Research Hospital İzmir, Turkey

  PRINCIPAL INVESTIGATOR

• Berna Kirilmaz Colak, MD

  Izmir Bozyaka Training and Research Hospital İzmir, Turkey

  PRINCIPAL INVESTIGATOR

• Bugra Ince, Assoc. prof.

  Izmir Bozyaka Training and Research Hospital İzmir, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

TU (1)