Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Change in Foot Ankle Pain Disability Survey scores
研究概览
简要总结
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).
详细描述
To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:
- •Pain on the bottom of the heel
- •Pain that is usually worse upon arising or after long periods of non weight bearing
- •Pain that increases over a period of months
- •Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
- •Morning mobility limitations
- •Preference of patients to "walk on their toes"
- •Paresthesias after non weight bearing (while sitting or lying down or both)
- •Nocturnal pain
- •Patients must be willing and able to sign the informed consent
排除标准
- •Achilles tendon injury
- •Acute traumatic rupture of the plantar fascia
- •Calcaneal bursitis
- •Calcaneal neuritis
- •Calcaneal stress fracture
- •Lumbosacral radiculopathy of S1 nerve root
- •Retrocalcaneal bursitis
- •Tarsal tunnel syndrome
研究组 & 干预措施
1
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CONTROL PATIENTS will only be treated with Standard of Care during this 12 week trial, but will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch after completion of this study.
干预措施: Ankle Dorsiflexion Dynasplint System (Device)
2
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). EXPERIMENTAL PATIENTS will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
干预措施: Ankle Dorsiflexion Dynasplint System (Device)
3
ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CROSS-OVER patients will be initially treated only with Standard of Care, and after six weeks, they will be Crossed-Over and fit with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
干预措施: Ankle Dorsiflexion Dynasplint System (Device)
结局指标
主要结局
Change in Foot Ankle Pain Disability Survey scores
时间窗: 12 weeks
次要结局
未报告次要终点