Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.
详细描述
This randomised-controlled single-blind prospective study was carried out at a Physical Medicine and Rehabilitation out-patient clinic. After approval by the Ethics Committee, all participants signed a written informed consent form. The research was conducted in accordance with the Helsinki Declaration.
Participants
The study will include individuals with lateral epicondylitis who are between the ages of 20 and 60 and have had elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis. Patients with the following exclusion criteria were not accepted into the study:
- Recent upper-extremity surgery,
- Recent upper extremity trauma, fracture, or dislocation,
- Upper-extremity peripheral neuropathy,
- Infectious processes of joint or soft tissues of the upper extremity
- Decompensated heart or respiratory failure
- Rheumatologic Diseases
- Psychiatric Disorders
- History of allergy to ingredients of injection solution
Demographic informations were recorded. Severity of elbow pain in resting, activity and if present night pain were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash) and Oxford Elbow Score.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers Tenderness over the lateral epicondyle
排除标准
- •Recent upper-extremity surgery,
- •Recent upper extremity trauma, fracture, or dislocation,
- •Upper-extremity peripheral neuropathy,
- •Infectious processes of joint or soft tissues of the upper extremity
- •Decompensated heart or respiratory failure
- •Rheumatologic Diseases
- •Psychiatric Disorders
- •History of allergy to ingredients of injection solution
结局指标
主要结局
VAS
时间窗: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Pain Severity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash)
时间窗: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Functional Disability. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. The DASH score is one of the most established questionnaires for disorders of the upper limb.
Oxford Elbow Score
时间窗: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Functional Disability. The outcome can be interpreted based on a 48-point scale: 0-19, poor; 20-29, fair; 30-39, good; and 40-48, excellent
次要结局
未报告次要终点
研究者
Sibel süzen Özbayrak
M.D.
Haydarpasa Numune Training and Research Hospital