Demonstration and Comparison of 5% Dextrose Prolotherapy and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
In the treatment of lateral epicondylitis, 5% dextrose prolotherapy is aimed to be more reliable than 15% prolotherapy in terms of side effects and to show that it is similar in terms of efficacy in treatment.
详细描述
For this prospective randomized controlled study, volunteer patients who met the inclusion criteria and applied to the Health Sciences University, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic will be included in the study. Participants who volunteered for the study will be divided into study groups and control groups by stratified randomization. A total of 26 volunteers will be recruited.
A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline.
In the beginning, all patients were asked about gender, age, body mass index, education level, occupation, duration of complaint, dominant side and affected extremity, previous treatments, and when the last treatment was applied.
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.
Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
- •tenderness on palpation over the lateral epicondyle
- •Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
- •> 20 years old , < 60 years old
排除标准
- •Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
- •Having a history of malignancy,
- •Pregnant cases,
- •Those who have bone and joint diseases in the neck, shoulder and elbow,
- •Patients with infection in the treatment area,
- •Patients with arrhythmia or pacemaker in the heart,
- •Patients receiving coagulation disorder or anticoagulant therapy,
- •Those with local dermatological problems,
- •Patients with a history of surgery in the elbow joint,
- •Having a tendon tear
- •Presence of nerve involvement
- •Lack of cooperation and refusal to participate in the study due to cognitive dysfunction
结局指标
主要结局
Pain intensity
时间窗: Change from baseline pain intensity at 3, 6, and 12 weeks
Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level.
The upper extremity disability level
时间窗: Change from baseline upper extremity disability level at 3, 6, and 12 weeks
The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level.
次要结局
- Hand grip strength(Change from baseline hand grip strength at 3, 6, and 12 weeks)