NCT01326351Unknown4 期
Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy
Réseau de Santé Vitalité Health Network2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of pain and function of the affected foot during the course of treatment
研究概览
简要总结
The purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of Plantar Fasciitis
- •experience pain in the plantar fascia for more than 6 months
- •be capable to understand and execute physiotherapy exercises
排除标准
- •previous operation of the plantar fascia
- •deformation of the foot (congenital or acquired)
- •presence or suspicion of infection of the skin at the site where the injection will occur
- •history of systemic diseases capable of inducing pain or sensitivity to the feet (seronegative arthritis, diabetes, fibromyalgia, etc.)
- •abnormal coagulation
- •allergy to lidocaine and/or marcaine
- •pregnancy
- •lumbar, hip or knee pain
结局指标
主要结局
Assessment of pain and function of the affected foot during the course of treatment
时间窗: Every 3 weeks from week 0 to 36
The Maryland Foot Score questionnaire will be used. This questionnaire assesses pain and function of injured foot using a summated rating scale of 10 questions.
次要结局
- Assessment of pain intensity and pain-related function impairment during the course of treatment(Every 3 weeks from week 0 to 36)
研究者
研究点 (2)
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