Dynamic Versus Static Night Splinting of Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- NO pain at 1 month follow up
研究概览
简要总结
The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.
详细描述
A physical rehabilitation device for the treatment of a medical condition of the foot known as plantar fasciitis includes a splint which is connected to the toe and ankle of a patient. Static splint is the use of inelastic components to apply torque to a joint in order to statically position it as close to end range as possible. A dynamic splint uses a tension spring that is integrated into a brace, usually via a mechanical hinge. The tension spring can be adjusted for more or less tension to achieve range of motion goals with less pain. The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demographic - Over 18 years of age and ambulatory without a gait aid with no history of narcotic use
- •Diagnosis - Unilateral or bilateral acute (< 6 months of pain) plantar fasciitis (i.e., Heel pain that increases with weightbearing, "First step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis)
- •Permitted - Icing, NSAIDS( ibuprofen), Custom Shoe Inserts, Diagnostic Ultrasound
排除标准
- •Demographic - Under 18 year of age, requires a gait aid for ambulation; if not covered by insurance,
- •Diagnosis of - Arthritis of the Ankle, Midfoot, or Forefoot; Inflammatory Arthritis; Gout; Turf Toe; Hallux Rigidus; Hallux Limitus; Sesamoiditis; Tendonitis or Tendinopathy; Prior tear or Rupture of the Plantar Fascia; Fibromyalgia, Neuralgia, or Neuropathy; Peripheral Vascular Disease; Prior Trauma to the Heel, Fracture of the Calcaneus; Infection; Corn; Callus; Ingrown Nail.
- •Patient with history of Symptoms for over 6 months
- •Refractory to prior splint-based treatments
- •Prior injection of the plantar fascia
- •Prior surgery on the plantar fascia
- •Narcotic use
研究组 & 干预措施
Control( static splinting)
conventional static splint
干预措施: Dynamic splint (Device)
Experiment( dynamic splinting)
Device treats plantar fasciitis and replacing boot immobilization
干预措施: Dynamic splint (Device)
结局指标
主要结局
NO pain at 1 month follow up
时间窗: 1 months
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
NO pain at 6 months follow up
时间窗: 6 months
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
NO pain at 3 months follow up
时间窗: 3 months
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
NO Pain at 1 Month Follow up
时间窗: 1 months
Pain measured on a visual analog scale (VAS): score range: 0 (no pain) to 10 (worst pain)
NO Pain at 3 Months Follow up
时间窗: 3 months
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)
NO Pain at 6 Months Follow up
时间窗: 6 months
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)
次要结局
- Clinically relevant change in Foot Function Index (FFI)(6 months)
- Foot Function Index (FFI) Score(1 month)
- Foot Function Index (FFI)(3 months)
- Foot Function Index (FFI)(6 months)
研究者
Loretta Chou
Professor
Stanford University