Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.
The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.
Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.
Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and over
- •Diagnosis of chronic lateral epicondylalgia
- •Sign the informed consent form
排除标准
- •Concomitant conditions affecting the same upper extremity
- •Contraindications for Diacutaneous Fibrolysis
- •Corticosteroid injections or similar agents in the three months prior to study inclusion
- •Pending litigation or legal claim
- •Poor language and communication skills making difficult to understand the informed consent
结局指标
主要结局
Pain intensity
时间窗: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain intensity (VAS)
次要结局
- Pain free grip strength(pre-intervention, post-intervention (two sessions in a week during three weeks), after three months)
- Functional status(pre-intervention, post-intervention (two sessions in a week during three weeks), after three months)
- Pressure Pain Threshold(pre-intervention, post-intervention (two sessions in a week during three weeks), after three months)
- Global Rating of Change scale(post-intervention, after three months)