Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.
研究概览
简要总结
A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.
详细描述
The attached recruitment flyers will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the AcuFlex™ device for 5 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.
We will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of a United Ortho fitted night splint. Those with an even number will be provided with an AcuFlex™ unit to be used at home a minimum of 5 minutes 2-3 times per day. If at any point the number generator fills maximum participants (50) for either AcuFlex™ or night splints, the remaining participants will automatically be assigned the remaining method of home therapy.
The participants will use their device for 6 weeks. They will receive a check-in phone call at the 3 week mark of their participation.
Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.
Participant's random number will be used to link data in the study to the participant. We will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •age 18 years and older
- •diagnosis of plantar fasciitis
- •ability to understand the purpose of the study
- •ability to safely use the device they are assigned after education and return demonstration.
排除标准
- •patients with ankle fusion
- •significant balance impairment which would prohibit safe use of the AcuFlex device
- •corticosteroid injection within last 60 days
- •pregnancy
研究组 & 干预措施
Main study
This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms.
干预措施: Night splints (Device)
Main study
This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms.
干预措施: Triceps Surae Stretching and Flexibility Assessment Device (TESS) (Device)
结局指标
主要结局
Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.
时间窗: 6 weeks
The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the AcuFlex device to night splints in symptom relief.
次要结局
未报告次要终点