Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria
- •Knee OA is of Kellgren-Lawrence stage 2-4
- •The participant gives signed consent
排除标准
- •Exclusion Criteria:
- •1. Having diabetes mellitus
- •Chronic kidney failure
- •Hypothyroidism
- •Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity
- •Neurological diseases that can cause neuropathic pain
- •Presence of fibromyalgia
- •Neurological deficit in the lower extremity
- •Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months
- •Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months.
结局指标
主要结局
Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire
时间窗: 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.
次要结局
- 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)
- 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)
- Sleep quality(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)
研究者
Taciser Kaya
MD, Professor
Bozyaka Training and Research Hospital