Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment.
研究概览
简要总结
Objectives: This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness.
详细描述
Design: This randomized clinical trial included 44 adults (18+) with heel pain and plantar fasciitis. Participants received hard or soft customized orthotics and rated their pain intensity, pain interference and function, pre and post orthotic use. Scores were analyzed with repeated measures ANOVA. Analysis of age used repeated measures ANOVA. Costs were compared using t-test and number of visits was compared using Wilcoxon Rank Sum.
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)
盲法说明
The research assistant was blinded to the type of orthotic provided to the participant to prevent possible bias during administration of the post treatment questionnaire.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sample of convenience from the hospital and private clinic. The participants had heel pain associated with plantar fasciitis. Participants could describe and report changes in their pain
排除标准
- •Those excluded were non-ambulatory (unable to walk greater than 25 meters) orchid spasticity due to a neurological disorder. Others excluded were non-communicative, had cognitive impairment or were unable to complete a questionnaire.
结局指标
主要结局
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment.
时间窗: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10)
次要结局
- Late Life Function and Disability Instrument (Late Life FDI): Function component. Change in function is being assessed using this measurement tool pre and post treatment.(This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.)
- Brief Pain Inventory: a sub-scale from this measurement tool measuring pain interference with activity and level of function. Change in pain interference is being assessed using this measurement tool pre and post treatment.(This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.)
研究者
Deborah Seligman, MSc., B.Sc.O.T.
Occupational Therapist
University of Toronto