Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- PROMIS-Pain interference
研究概览
简要总结
Plantar fasciitis (PF), a leading cause of persistent heel pain, results in almost a million physician visits annually. Conservative treatment is often the first line of management with insoles being frequently prescribed. While multiple studies have compared insoles based on the degree of customization to foot contour, the literature is lacking in data comparing insoles based on their material. In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and carbon fiber insoles in the treatment of PF, using a set of patient-reported outcomes.
详细描述
Carbon fiber insoles (VKTRY, Milford, CT, USA) were initially designed to increase ground forces leading to a harder push off for faster running or higher jumping. To enable energy return, the insoles require extreme rigidity and therefore are composed of a full-length carbon-fiber base. The highly rigid construct of the carbon fiber can potentially benefit patients with plantar fasciitis by using these insoles in their own shoes, which could lead to more effective pain management, increased compliance, and improved patient outcomes. While this insole is currently being widely used by athletes, the application of this insole for PF patients has not been explored. Therefore, the aim of this study is to understand how patients respond to the these insoles compared to current standard orthotics (Superfeet Green, Superfeet Worldwide LLC. WA, USA and Aetrex L20, Aetrex Inc, NJ, USA) in a blinded randomized controlled trial.
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
- None
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
- •Adult patients (over 18 years old) with plantar fasciitis
- •Adults who are competent and able to consent on their own behalf
- •Patients who are seen at MGH Boston, MGH Waltham and Newton Wellesley Hospital
排除标准
- •Patients who received an injection in the last 6 months in their plantar fascia
- •Patients who will need to be treated surgically
- •Patients who are non-English speaking
结局指标
主要结局
PROMIS-Pain interference
时间窗: Baseline, 2nd-, 6th-, and 12th-week follow-ups
measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities
PROMIS-Pain intensity
时间窗: Baseline, 2nd-, 6th-, and 12th-week follow-ups
assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly
次要结局
- Foot and Ankle Outcome Score(Baseline, 2nd-, 6th-, and 12th-week follow-ups)
- Visual Analogue Scale for pain(Baseline, 2nd-, 6th-, and 12th-week follow-ups)
研究者
Soheil Ashkani Esfahani
Director, Foot and Ankle Research and Innovation Laboratory
Massachusetts General Hospital