Comparison of Commonly Used Treatment Approaches in the Treatment of Gonarthrosis: Platelet-Rich Plasma, Topical Diclofenac, and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change of Pain via Numeric Pain Rating Scale
研究概览
简要总结
Osteoarthritis, the most common type of arthritis, is a chronic and degenerative joint disease. It has been reported to affect more than 300 million adults and elderly individuals worldwide. The joint most commonly affected by osteoarthritis is the knee joint and this condition is called gonarthrosis.
The goal of treatment is to reduce symptoms and ultimately slow the progression of the disease with various treatment options throughout the course of the disease.Current clinical studies prepared by the working groups of the International Osteoarthritis Research Society (OARSI) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) According to the guidelines, treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids. Exercise-oriented physiotherapy is one of the main approaches for the conservative treatment of gonarthrosis. The curative clinical effect of exercise therapy on pain and functional disability in gonarthrosis is important.
The use of PRP in the treatment of gonarthrosis is based on the ability of platelets to release biologically active proteins and promote tissue healing. Since the cartilage tissue mainly affected in gonarthrosis has low healing potential, this feature of platelets becomes more important for the target tissue. Existing studies show that PRP is superior to hyaluronic acid in intermediate and initial gonarthrosis; on the other hand, less satisfactory results are reported in severe gonarthrosis, similar to viscosupplementation.
Topically or orally administered NSAIDs form the backbone of pharmacological treatment in gonarthrosis.
It is seen that both exercise, PRP and topical NSAID agents are among the recommendations in the treatment of gonarthrosis. However, there is insufficient evidence regarding the superiority and therapeutic efficacy of these three treatment approaches. The aim of this study is to determine the effectiveness of "exercise", "PRP" and "NSAID-specific topical agents" in the treatment of patients with gonarthrosis; pain, function, quality of life, and patient satisfaction.
详细描述
Voluntary participants who have been diagnosed with gonarthritis will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into tree groups. Study groups will be as follows: a) exercise, b) topical diclofenac, c) platalet-rich-plasma (PRP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gonarthrosis according to the criteria of the American Society of Rheumatology (ACR)
- •Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria,
- •Those between the ages of 40 and 65,
- •Body mass index below 30 kg/m2,
- •Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS,
- •Patients who do not have any barriers to being included in the exercise program
排除标准
- •Being in stage 4 according to Kellgren Lawrence radiological staging criteria,
- •Hemoglobin level <11.5 g/dL
- •Platelet level <100,000/μL
- •Thrombocytopenia, coagulopathy, crystal arthropathy, hemophilia or hematological malignancy,
- •Presence of active infection or tumor,
- •Chronic antiaggregant use or taking immunosuppressive therapy,
- •Pregnancy or lactation,
- •Viscosupplementation or steroid injection in the related knee in the last 3 months, or using systemic steroids,
- •To have received a physiotherapy program for the relevant knee in the last 3 months,
- •Having a valgus or varus deformity greater than 15°,
- •Presence of neurological diseases and/or deformity leading to lower extremity muscle weakness
- •Having serious systemic and cardiovascular diseases that interfere with exercise
研究组 & 干预措施
Intervention Group 1
The patients in the Exercise group will be treated with a structured exercise program. The exercises will be applied by the research physiotherapist for 6 weeks, 2 days a week. Each training session is planned to last approximately 30 minutes.
干预措施: Exercise (Other)
Intervention Group 3
The PRP procedure with the same characteristics will be used in the treatment of patients in the PRP group. The PRP application will be prepared by the orthopedics and traumatology specialist physician in the research team, using the kits provided within the scope of the project. In order to collect venous blood for the PRP production procedure, gamma sterile vacuum tubes and blood collection set in special kits without the risk of contamination will be used. A total of 3 doses will be administered to the patients, with a one-week interval between doses.
干预措施: Platelet-Rich-Plasma (PRP) (Other)
结局指标
主要结局
Change of Pain via Numeric Pain Rating Scale
时间窗: change from baseline pain at 6 months
On this scale, "0" indicates the absence of pain, and "10" indicates the most severe pain imaginable. Patients will be asked to rate the severity of their knee pain with a number between 0 and 10 using this scale. The minimum clinically significant difference value (MCID) of this valid and reliable pain scale is 1.74 points.
次要结局
- 40 meters fast walking test(4 times for 24 weeks)
- Stepping Test(4 times for 24 weeks)
- WOMAC(4 times for 24 weeks)
- Global Rating of Change Scale-GRC(4 times for 24 weeks)
- Joint Range of Motion Evaluation(4 times for 24 weeks)
- Health-Related Quality of Life Short Form-12 Scale (SF-12)(4 times for 24 weeks)
研究者
Sezen Karaborklu Argut
Principal Investigator
Istanbul University - Cerrahpasa