A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
研究概览
简要总结
Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result.
Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two identical laser devices are used, where one is active and the other is sham. One laser device has a 3x60 mW output power and the other one has 0 mW output power (sham).
These are labelled with yellow or blue tape by a secretary who is otherwise not participating in the study.
Since the laser device has an invisible beam (904 nm wavelength) and is of such low power that heat is not detected, both the participant and the clinician will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.
排除标准
- •Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.
结局指标
主要结局
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
时间窗: Change from baseline to week 4 and 12
Range 0-100
Pain (Numerical Rating Scale)
时间窗: Change from baseline to week 4 and 12
Range 0-10
次要结局
- Pain pressure threshold algometry(Change from baseline to week 4 and 12)
- Jump for distance(Change from baseline to week 4 and 12)
- Neovascularization in the Achilles tendon(Change from baseline to week 4 and 12)
- Qualitative assessment of structural changes of the Achilles tendon(Change from baseline to week 4 and 12)
- Palpation tenderness(Change from baseline to week 4 and 12)
- Single legged heel raise(Change from baseline to week 4 and 12)
- Thickness of the Achilles tendon(Change from baseline to week 4 and 12)
- Qualitative assessment of effusion within of the Achilles tendon(Change from baseline to week 4 and 12)