Effects of Dextrose Prolotherapy on Pain, Muscle Strength, Proprioception and Quality of Life in Patients With Knee Osteoarthritis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from baseline pain score at 1-months, 3-months and 6-months
研究概览
简要总结
In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.
详细描述
Patients admitted to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of knee osteoarthritis and who meet the inclusion criteria will be included in the study. Patients will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Consent Form" after their consent is obtained.
In our study, the investigators aimed to evaluate the effects of dextrose prolotherapy injections in patients with chronic knee osteoarthritis. The duration of the study was determined as 8 months and it was planned to include 33 patients for each group to be randomized by computer program according to the order of application and 66 patients in total.
Patients who meet the inclusion and exclusion criteria will be randomized into 2 groups and the first group will receive Dextrose Prolotherapy and home exercise program and the second group will receive saline injection and home exercise program.
After the application, patients will be questioned in terms of side effects and complications.
History and demographic characteristics such as age, gender, height, weight, marital status, educational level and occupation will be questioned, and medical history such as history of comorbidities and treatment approaches will be determined. In the physical examination, knee tests (ROM measurements, ligament tests, meniscus tests, tests for osteoarthritis) will be performed and TUG (Timed Up and Go) Test will be evaluated. Direct knee radiographs will be evaluated according to Kellgren-Lawrence Gonarthrosis Staging. The average and maximum level of pain during activity, at rest and at night will be questioned with the Visual Analog Scale (0-10 points). WOMAC pain score and WOMAC total scores will be questioned. Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer in our clinic. Functional status will be evaluated with Euro-Qol Quality of Life Scale. The evaluations will be performed by the researcher who is blinded to the applications.
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)
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
- •Unilateral or bilateral symptomatic knee pain resistant to conservative treatment for at least three months
- •Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- •40-65 years of age
- •Functional ambulation scale stage 4-5
排除标准
- •Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
- •Intra-articular knee injection within the last six months
- •History of severe trauma to the knee within the past six months
- •Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- •Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
- •Having a bleeding disorder and / or using warfarin
- •Patients with hemoglobin less than 11g/dL and platelet count of less than 150,000 platelets per microliter
- •Presence of uncontrolled diabetes mellitus
- •Presence of cardiac or systemic disease that may affect exercise
- •The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
- •Body Mass Index ≥35 kg/m²
- •Allergy to local anesthetic
结局指标
主要结局
Change from baseline pain score at 1-months, 3-months and 6-months
时间窗: Baseline, 1-month, 3-month, 6-month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
次要结局
- Change from baseline muscle strength and proprioception at 3-months and 6-months(Baseline, 3-month, 6-month)
- Change from baseline stiffness and physical function at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline activity pain score at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline quality of life at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline rest pain score at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline night pain score at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline functional balance at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
研究者
Ekin Ilke Sen
Assistant Professor
Istanbul University