NCT02608723已完成4 期
Chronic Plantar Fasciitis Treated With Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes? A Randomized Controlled Clinical Trial.
Asociacion Colaboracion Cochrane Iberoamericana2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Function of the foot
研究概览
简要总结
To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.
详细描述
Study Design: a controlled, randomized, parallel assessor-blinded clinical trial.
Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups:
- Group I: Treatment applied by standard shock waves device.
- Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated.
- Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance.
The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device.
The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years.
- •Being able to understand the explanations about the potential benefits and risks of study participation.
- •Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:
- •Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity).
- •Pain during the first steps to get out of bed in the morning and / or after a period of rest time.
- •With a duration of symptoms ≥ 6 months at the time of study entry.
- •Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.
排除标准
- •Bilateral plantar fasciitis.
- •Hiper/ hypothyroidism.
- •Diabetes mellitus.
- •Treatment with anticoagulants
- •Inflammatory diseases.
结局指标
主要结局
Function of the foot
时间窗: Four months
FFI (Foot Function Index) questionnaire
次要结局
- Painkillers consumption(Four months)
- Adverse effects(Four months)
- Pain(Four months)
- Plantar fascia thickness(Four months)
- Perception of patient recovery(Four months)
研究者
研究点 (2)
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