Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis.
Participants will receive an autologous whole blood injection over the plantar fascia, and will be followed up to study the response.
Researchers will compare the effects with a control group who will receive normal saline injection.
详细描述
Research objectives and hypothesis. The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.
The hypothesis is that AWB injection is more effective than sham injections in the treatment of plantar fasciitis.
Study design and research methods:
- Study design:Randomized prospective single blinded study
- Primary and secondary endpoints:
Patients will be followed 6, 12, 24 weeks, and 12 months after the injection to assess the effects and improvement of symptoms.
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
- Double (Participant, Outcomes Assessor)
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 with chronic plantar fasciitis (persistence of symptoms despite 12 weeks of conservative management)
- •Age: adults patients more than 18 years
- •Not having responded to primary conservative managements such as rest, shoe insoles, conventional physical therapy, exercise therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs).
排除标准
- •Neurological or vascular insufficiencies in the painful heel
- •Osteomyelitis, fracture of the calcaneus
- •Recent infection in the treatment area, history of rheumatic diseases
- •Immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
- •Previous heel surgery
- •Patient with diabetes mellitus,
- •Received corticosteroid injection
- •Four weeks since the last anaesthetic injection, iontophoresis, ultrasound and
- •electromyostimulation
结局指标
主要结局
Visual Analog Scale
时间窗: 12 months
Visual Analog Scale (VAS) to assess the pain score from 0 (minimum) to 10 (maximum)
Change in Plantar fascia thickness
时间窗: before the treatment and 12 months after the treatment.
Measurement of the change in plantar fascia thickness using ultrasound
Foot Function Index
时间窗: 12 months
a questionnaire based index to assess the foot function (from 0% minimum to 100% maximum)
Foot and Ankle Ability Measure (FAAM)
时间窗: 12 months
a questionnaire based index to assess foot and ankle ability in various daily life activities.
次要结局
未报告次要终点
研究者
Wafa Al Baluki
Consultant foot and ankle orthopaedics surgeon
Sultan Qaboos University