Use of PRP to Treat Plantar Fasciitis, Blinded and Randomized as a Multi Center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 5
- 主要终点
- Percentage of successfully treated patients
研究概览
简要总结
Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections. Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the tendon might induce a healing rate.
Objective: To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
详细描述
Plantar fasciitis is the most common cause of foot complaints in the United States, making up 11 to 15 percent of the foot symptoms requiring professional care among adults (Pfeffer et al., 1999; Cole et al., 2005). A 2004 publication found that there are approximately 1 million patient visits per year to office-based physicians and hospital outpatient departments in the United States for plantar fasciitis (Riddle et al., 2004). This figure does not consider podiatric physicians visits, including these numbers would raise the overall physician visits related to plantar fasciitis considerably. The incidence of plantar fasciitis peaks in people between the ages of 40 to 60 years with no bias towards either sex (Taunton et al., 2002) The underlying condition that causes plantar fasciitis is a degenerative tissue condition that occurs near the site of origin of the plantar fascia at the medial tuberosity of the calcaneous (Buchbinder, 2004). In acute cases, plantar fasciitis is characterized by classical signs of inflammation including pain, swelling and loss of function. For more chronic conditions, however, inflammation is not the underlying tissue disruption. In fact, histology of chronic cases has shown no signs of inflammatory cell invasion into the affected area (Lemont et al., 2003). The tissue instead is characterized histological by infiltration with macrophages, lymphocytes, and plasma cells; tissue destruction; and repair involving immature vascularization and fibrosis (Lemont et al., 2003). The normal fascia tissue is replaced by an angiofibroblastic hyperplastic tissue which insuitates itself throughout the surrounding tissue creating a self-perpetuating cycle of degeneration (Lemont et al., 2003). In these chronic cases, the suffix 'itis' is a misnomer with plantar fasciosis being a more apt description of the underlying histology.
Conservative treatments including stretching protocols and foot orthoses resolve many cases of plantar fasciitis, with reports for patients in orthopedic practices being around 80 percent resolution (Cole et al., 2005; Wolgin et al., 1994; Martin et al., 1998; Davies et al., 1999). For more chronic cases, a number of non-surgical interventions are utilized including extracorperal shock wave therapy and corticosteroid injections (Cole et al., 2005; Speed et al., 2003; Acevedo, Beskin, 1998). The use of corticosteroids is particularly troubling as several studies have linked plantar fascial rupture to repeated local injections of a corticosteroid (Cole et al., 2005; Sellman, 1994; Leach et al., 1978; Acevedo, Beskin, 1998).
All of these methods are limited in their efficacy for cases of chronic plantar fasciitis due to the fact that none of them adequately addresses the full scope of the underlying tissue degeneration. This frequently leaves surgical intervention as the only viable option in these chronic cases.
The goal of treatment for chronic plantar fasciitis should be to cease and ultimately reverse the degenerating tissue disruption that is at the root of the condition. The three steps critical to full repair of the effected tissue are:
- Enhancing the influx and proliferation of fibroblasts into the effected area. This will allow for a tissue bed that is extremely receptive to vascularization
- Promote angiogenesis to develop a mature vascular structure in the effected area
- With a mature vascularization, collagen deposition can then occur, resulting in the organization of fully mature tendon tissue
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •No bias to sex
- •> 18 years
- •Chronic plantar fasciitis or proximal recalcitrant plantar heel pain (6-12 months duration)
- •Failed conservative treatment
- •Able to understand the informed consent
- •VAS pain in morning by first steps higher as 5 (0-10 scale)
排除标准
- •Received local steroid injections within 6 weeks, physical/occupational therapies within 4 weeks, or non-steroidal anti-inflammatory within 1 week prior to randomization
- •Inability to fulfil follow-up criteria
- •Significant cardiovascular, renal or hepatic disease
- •(Local) malignancy
- •History of amenia (hemoglobin < 5.0 )
- •Previous surgery for plantar fasciitis
- •Active bilateral plantar fasciitis
- •Diagnosis of vascular insufficiency or neuropathy related to heel pain
- •Hypothyroidism
- •Diabetics
- •No other painful or function limited disorders of the foot and ankle
研究组 & 干预措施
L-PRP Injection
L-PRP produced with Biomet Recover L-PRP Platelet Separation Kit
干预措施: L-PRP Injection (Device)
Steroid Injection
Corticosteroid injections
干预措施: Corticosteroid Injection (Drug)
结局指标
主要结局
Percentage of successfully treated patients
时间窗: 6 months
次要结局
- Pain reduction(0-12 months)
- Function(0-12 months)
- Complications and reinventions(0-12 months)
- Patient satisfaction(0-12 months)
