A randomized control trial to compare the effect of platelet rich plasma and dextrose prolotherapy in patients of chronic severe plantar fasciitis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in sonographic appearance of the plantar fascia, with respect to thickness and presence or absence of hypoechogenic foci
研究概览
简要总结
Plantar fasciitis is the most common cause of inferior heel pain affecting 10-15% of general population at least once in their lifetime. Studies have shown that roughly 10 percent of plantar fasciitis patients are nonresponders to conservative treatment.
Surgical correction of plantar fasciitis involves open/percutaneous or endoscopic plantar fascia release which is associated with increased stress on ligaments of forefoot and midfoot resulting in further complications. This creates a window for injection therapies in non-responders to conservative management. Commonly used local steroid injection has been associated with atrophy of plantar fascia, subcutaneous fat and even plantar fascia rupture. Moreover, steroids are generally indicated in acute, not chronic cases, which is the focus of this study.
On the other hand, prolotherapy with dextrose (DP) has been reported to decrease pain and improve function in a variety of tendinopathies, by upregulating multiple mitogenic factors. And, complete resolution of symptoms at one year was reported in 75% of subjects with plantar fasciitis treated with PRP by Barrett SL et al.
But, no trial has directly compared the effectiveness of dextrose prolotherapy with PRP in chronic plantar fasciitis in Indian population. Nor have any studies compared change in ultrasound parameters, as an outcome measure between PRP and DP in chronic plantar fasciitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed with unilateral or bilateral plantar fasciitis having no improvement with conservative management for ≥ 3 weeks.
- •2.Physical examination revealing maximum tenderness at the attachment of plantar fascia on the medial tubercle of the calcaneus.
- •3.Ultrasound examination showing plantar fascia thickness ≥4 mm or difference in plantar fascia thickness ≥1 mm in symptomatic heel in comparison to asymptomatic heel at inferior border of the calcaneus.
- •4.In bilateral cases, foot with more clinical severity is taken into the study.
排除标准
- •1.Received local steroid injection within 6 months
- •NSAID use 7 days prior to randomization
- •History of anaemia or bleeding disorders
- •Previous surgery for plantar fasciitis
- •Achilles tendon pathology 6.Diagnosed case of local malignancy 7.Diagnosed case of rheumatological diseases 8.Uncontrolled diabetes mellitus 9.Patients on anticoagulation therapy
- •Diagnosis of vascular insufficiency or neuropathy related heel pain (radiculopathy, tarsal tunnel syndrome) and other causes of heel pain
- •Any local trauma or infection.
- •12.Not willing to participate in study.
结局指标
主要结局
Change in sonographic appearance of the plantar fascia, with respect to thickness and presence or absence of hypoechogenic foci
时间窗: 0 weeks , 4 weeks, 8 weeks
次要结局
- Change in functional outcome assessed by Foot Function Index(0 weeks, 4 weeks, 8 weeks)
- Change in symptom severity assessed by Foot Function Index(0 weeks, 4 weeks, 8weeks)