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NCT Number: NCT06430918

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Osteoarthritis Osteoarthritis, Knee Pain Parasomnias Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Bozyaka Training and Reseach Hospital

Izmir, 35300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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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Treatment and study plan

physical examination, questionnaires and inventories

Other

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

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

Primary outcomes

  1. Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire

    Time frame: 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.

Secondary outcomes

  1. Sleep quality

    Time frame: through study completion, an average of 1 year

    Jenkins Sleep Scale.The four-item questionnaire evaluates the frequency and intensity of certain sleep difficulties in respondents. Questions queries the number of days in which the patient was subjected to sleep problems. The maximum possible score is 20 and higher scores indicate much more sleep disturbance. A mean score of two or more is considered as sleep disturbance presence.

  2. Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS)

    Time frame: through study completion, an average of 1 year

    The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. It is used to detect whether the patient is in the depressive or anxious status. It is not a diagnostic tool but gives to physician an idea about the patient's emotional status. It consists of fourteen items. Seven items are related to anxiety and the other seven depression

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

    Time frame: through study completion, an average of 1 year

    KOOS evaluates the symptoms and functional problems related to knee OA and knee injury. It consists of five subscales. In this study authors intended to assess the life quality by using the quality of life level subscale of this scale.

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

    Time frame: through study completion, an average of 1 year

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

  5. 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.

    Time frame: through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 28, 2024
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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