The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Knee Pain
研究概览
简要总结
Dextrose prolotherapy is a form of treatment in which hypertonic dextrose solution is used as a stimulant solution and regeneration is increased by stimulating the body's natural healing mechanisms after injection.
The aim of this study is to compare the dextrose prolotherapy applied with home exercise program and saline injections as a control group in patients who applied to our clinic with knee pain and diagnosed with chondromalacia patella, and to investigate the effectiveness of dextrose and saline on the job to determine the superiority of the injections to each other.
详细描述
The study was designed as prospective, randomized, controlled trial. 48 people who met the inclusion criteria were randomized into two groups of 24 people. The first group will be designated as Dextrose Prolotherapy Group and dextrose prolotherapy and exercise program will be applied to these patients. Patients in the second group will be designated as the Serum Physiological Group, and injections with saline and home exercise program will be applied in accordance with the prolotherapy protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala Patellofemoral Scoring System (KPSS) and Short Form 36 (SF-36).Knee cartilage thickness measurements and the presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated bilaterally by ultrasonography and the findings will be recorded.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female / male aged> 18 years
- •Diagnosis of chondromalacia patella after physical examination and imaging (direct radiography, MRI)
- •Those whose symptoms persist> 3 months
- •Does not have a disease that will prevent him from exercising
- •Participation in the study voluntarily and regularly
排除标准
- •Pregnant patients
- •History of previous knee surgery
- •Having received physical therapy from the knee area in the last 3 months
- •Drug allergy
- •Previous prolotherapy or any injection up to 3 months ago
- •Those with pain reflected from waist or hip
- •Patients with neuropathic pain
- •Tumor, infectious, psychiatric illness, history of bleeding diathesis
- •Having a trauma history in the last 6 months
- •Those with systemic diseases such as diabetes, hepatitis, coagulopathy
- •Those with cerebrovascular event disease in which bleeding continues actively
- •Those who received NSAID treatment within the last week
- •Patients with a BMI> 40
- •Finding leg length difference
结局指标
主要结局
Knee Pain
时间窗: initial, 4th week 7th week 24th week pain change
Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
次要结局
- Patello Femoral Pain Intensity Scale(initial, 4th week 7th week 24th week pain change)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital