An interventional study compararive study to compare the effect of Ultrasound-Guided methylpredinsolone acetate injection versus dextrose prolotherapy in management of plantar fasciitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1. Pain intensity with Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of our study is to evaluate and compare the therapeutic effect of ultrasound guided methylprednisolone acetate (MPA)versus dextrose prolotherapy injection in chronic PF. Most of the patients want to avoid steroid injection due to its possible side effects. The purpose of our study is to find a better/alternative, safer injection ( Prolotherapy) for the treatment of chronic plantar fasciitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of chronic plantar fasciitis
- •Those giving signed informed consent for study
- •Numeric Rating Scale score more than4 Duration of symptoms more than 2 months.
排除标准
- •1.History of any surgery or injection to the plantar fascia/heel in last 6 months.
- •2.History of trauma, fracture to heel or any other surgeries leading to any functional limitation of the affected foot.
- •3.Other medical/surgical condition other than PF producing heel symptoms: like peripheral neuropathy, positive tinel’s sign at the medial ankle, ischemia, systemic inflammation and connective tissue disease; history of disc herniation, etc.
- •4.History of any systemic disorders or bleeding disorders or intake of anticoagulants or other medical conditions where steroid/dextrose injection is contraindicated like uncontrolled diabetes, coagulation disorders, paresthesia or numbness at heel, presence of cyst, mass, or local skin infection at the site of pain.
- •5.Pregnant or lactating mothers.
- •6.Any special treatment taken in the past 4 weeks with interfere the outcome assessment, including iontophoresis, phonophoresis, and shockwave therap.
结局指标
主要结局
1. Pain intensity with Numeric Rating Scale (NRS)
时间窗: NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
2. Functional outcome measure with
时间窗: NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
A. The Foot and Ankle Ability Measure (FAAM)
时间窗: NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
B. Foot Function Index (FFI)
时间窗: NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
3. Ultrasonographic assessments
时间窗: NRS,FAAM,FFI and USG assessments at baseline, 2 weeks and 12 weeks
次要结局
- Functional outcome measure(With)
研究者
DR Chuka Kumari
SMS Medical College Jaipur