A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy With Platelet Rich Plasma Versus Extracorporeal Shock Wave Therapy in a High Demand Cohort With Resistant Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Edna Rath
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant Plantar Fasciitis
详细描述
The purpose of this proposal is to perform a high-quality pilot study testing the efficacy of ESWT in combination with PRP for the management of resistant plantar fasciitis. We endeavor to determine if the pilot evidence supports a large, randomized study; and to conduct a power analysis for the follow-on study. The proposed pilot study will be a prospective double-blinded randomized controlled trial comparing pain and functionality at the 3 week, 6 week, 12 week and 6 month marks between extracorporeal shock wave therapy (ESWT) with platelet rich plasma (PRP) injection versus extracorporeal shock wave therapy with placebo injection of normal saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Patients that are already selected for ESWT for the treatment of resistant plantar fasciitis as part of clinical care under the doctor-patient relationship
- •X-ray imaging studies (Plain radiographs) documenting no additional sources for heel pain within 12 months(all x-rays were conducted as part of standard of care and no radiation will be specific to the research study)
- •Active Duty Soldier as they are a high demand cohort with increased frequency of plantar fasciitis compared to the general population as outlined by Scher et al.
- •Previously tried conservative management meeting referral to Orthopaedics: Pain medications, taping, orthoses, night splinting or physical therapy
- •Body Mass Index (BMI) <40kg/m2
排除标准
- •• History of trauma* or previous injury to heel requiring operative intervention
- •All Soldiers pending medical board evaluation or punitive action
- •History of connective tissue disorder (e.g., Marfan's Syndrome, Ehlers-Danlos disease, Rheumatoid Arthritis, etc.)
- •Leaving the geographical area permanently or for extended periods of time forcing loss to follow up
- •Treatment for plantar fasciitis with injection within the last 6 months
- •Surgical indication or internal derangement of the foot
- •Chronic pain conditions
- •Pregnancy
- •Tarsal tunnel syndrome
- •Baxter's neuritis
- •Rigid flat foot
- •Active infection of the Foot overlying the injection area
- •Use of immunomodulators, immunosuppressives, or chemotherapeutic agents
- •Allergy or hypersensitivity to any of the proposed treatment medications
- •Any other clinically significant acute or chronic medical conditions (e.g., bleeding disorder) that, in the judgment of the Investigator, would preclude the use of a PRP or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
- •Trauma for this research study is defined as a specific event or mechanism of injury, such as a direct blow or twisting injury of the foot that initiated the onset of heel pain. The insidious onset of heel pain with prolonged running or other physical activity is not defined as a traumatic event.
研究组 & 干预措施
Platelet Rich Plasma Injection Group
shockwave therapy within standard of care using Ossatron system with intervention injection of platelet rich plasma (PRP) using Arthex system, into the plantar fascia at the calcaneal origin
干预措施: platelet rich plasma (Biological)
Placebo injection group
shockwave therapy with placebo normal saline injection
干预措施: Normal saline (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 3, 6, 12, 24 weeks
Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS
次要结局
- repeat treatment threshold(3, 6, 12, 24 weeks)
- Functional Ankle Ability Measure extended sports scale(3, 6, 12, 24 weeks)
- return to activity(3, 6, 12, 24 weeks)
- Functional Ankle Ability Measure (FAAM)(3, 6, 12, 24 weeks)
研究者
Edna Rath
Human Protection Director
William Beaumont Army Medical Center