A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Heel Pain
研究概览
简要总结
This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if they present for each of the following:
- •Pain at plantar fascial attachment to calcaneal tubercle and/or pain distal from tubercle along plantar fascial band
- •Typical post-static dyskinesia. Pain first steps in morning or when getting up after being seated for a period of time
- •Patients will be ambulatory with an age range of 18-75 with plantar heel pain present for no more than one year.
- •They will not have previous injection within 6 months or currently use prescription custom foot orthoses.
- •Patient history, exam, x-rays, and ultrasound will rule out other etiologies of heel pain including proximal or local nerve entrapment, arthritis, bone cyst or tumor, or stress fracture. Since most patients will likely self-treat this condition prior to seeking care, the investigators will allow a washout period (appendix) and acetaminophen rescue analgesia provision.
排除标准
- •Proximal musculoskeletal pathology (i.e., knee or hip arthritis, sciatica secondary to back pathology, significant limb length discrepancy.
- •Use of gait assistive devices (crutches, canes, walkers).
- •Inability to wear supportive closed toed shoes.
- •Lack of range motion at the first metatarsophalangeal joint or subtalar joint.
结局指标
主要结局
Heel Pain
时间窗: baseline, one month and three months
Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.
次要结局
未报告次要终点
研究者
Adam Fleischer
Assistant Professor
Rosalind Franklin University of Medicine and Science