Effects of Central Sensitization on Response to Conventional Physical Therapy in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
The aim of this study was to investigate the relationship between central sensitization (CS) and poor response to conventional physical therapy in patients with knee osteoarthritis (OA) by evaluating clinical parameters of pain and functionality.
84 knee OA patients with knee pain for at least 3 months and 30 healthy controls were included in the study. Socio-demographic features of the participants such as age, sex, body mass index (BMI), and duration of symptoms were recorded. Structural damage was assessed by knee radiography. Knee pain and functional status were evaluated by visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and immediately after the treatment. Additionally, the following measures were applied at baseline: Central Sensitization Inventory (CSI), Beck Depression Inventory (BDI), Insomnia Severity Index (ISI), Pain Catastrophization Scale (PCS), and PainDETECT Questionnaire (PD-Q). Pressure pain threshold (PPT) was measured with a digital algometer at the painful joint, near the joint area, and in a painless remote region. Patients with knee OA underwent a total of 15 sessions of conventional physical therapy program including hotpack, ultrasound (US), transcutaneous electrical nerve stimulation (TENS), and exercise 5 days a week, for 3 weeks. The control group had no treatment except for the PPT measurement to obtain the reference PPT values. After the treatment, the patients were divided into two groups as 'responders' and 'non-responders' according to their response to treatment. The relationship between the response to physical therapy and clinical parameters was evaluated.
详细描述
The aim of the present study was to investigate the relationship between central sensitization (CS) and poor response to conventional physical therapy in patients with knee osteoarthritis (OA) by evaluating clinical parameters of pain and functionality.
The study was planned as a prospective, cohort study. Patients presenting with knee pain lasting more than 3 months and diagnosed with primary knee OA according to the American College of Rheumatology (ACR) criteria were screened to be included in the study at the Department of Physical Medicine and Rehabilitation, Ankara University, Faculty of Medicine. The protocol was approved by the Ankara University Faculty of Medicine Clinical Research Ethics Committee (27.05.2019 and Decision No. 10-795-19) and the trial was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines.
Patients in the OA group underwent a total of 15 sessions of conventional physical therapy program including hotpack, ultrasound (US), transcutaneous electrical nerve stimulation (TENS), and exercise 5 days a week, for 3 weeks. Hot pack was applied for 10 minutes, US was applied continuously at 1 megahertz (MHz), 1.0 W/cm2 for 10 minutes, and TENS was applied for 30 minutes according to the patient's tolerance. The exercise program consisted of an active, active-assisted range of motion and isometric quadriceps strength training. The control group had no treatment except for the PPT measurements to obtain the reference PPT values. At the end of treatment, patients were divided into two groups as responders and nonresponders according to the Outcome Measures in Rheumatology (OMERACT) Osteoarthritis Research Society International (OARSI) OA responder criteria.
Demographic and Clinical Assessment:
At the beginning of the study, the age, gender, body mass index (BMI), and pain duration of all participants were recorded. All participants underwent physical examination including a patellar tap test, temperature increase, and range of motion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patient group:
- •patients with cervical or lumbar radiculopathy, systemic inflammatory disease, diabetic neuropathy, sensory loss due to chemotherapy or radiotherapy, fibromyalgia or chronic fatigue syndrome
- •patients with cognitive impairment or psychiatric illness that prevents cooperation during the evaluation
- •patients with a history of previous physical therapy or injections to the knee joints within the last 3 months
- •Control group:
- •subjects with an uncontrolled systemic disease
- •subjects with cognitive impairment that prevents cooperation
- •subjects with a diagnosis of knee osteoarthritis, chronic painful disease, peripheral neuropathy and rheumatological disease
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: 3 weeks
Assessment of pain
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Scale
时间窗: 3 weeks
Assessment of pain, stiffness, and physical function
次要结局
- Central Sensitization Inventory (CSI)(Baseline)
- Beck Depression Inventory (BDI)(Baseline)
- Pain Catastrophization Scale (PCS)(Baseline)
- PainDETECT Questionnaire (PD-Q)(Baseline)
- Insomnia Severity Index (ISI)(Baseline)
- Pressure pain thresholds (PPT)(Baseline)
研究者
Haydar Gok
Professor Doctor
Ankara University