Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in pain intensity (VAS) and occurrence of adverse events
研究概览
简要总结
This randomized, double-blind clinical trial aims to compare the clinical and imaging effects of autologous bone marrow aspirate versus platelet-rich fibrin injections in patients with chronic plantar fasciitis. The procedures are performed under ultrasound guidance to ensure precision and safety. The study evaluates pain reduction, foot function, and ultrasonographic changes in the plantar fascia at follow-up intervals.
详细描述
Chronic plantar fasciitis is a common cause of heel pain that may persist despite standard conservative measures such as physical therapy, stretching, orthoses, and corticosteroid injections. Regenerative medicine techniques, including autologous platelet concentrates and bone marrow-derived products, have emerged as potential alternatives to promote tissue healing and long-term symptom improvement.
This randomized controlled trial investigates and compares two minimally invasive orthobiologic interventions:
Bone Marrow Aspirate (BMA) - obtained from the posterior iliac crest under local anesthesia and injected into the most symptomatic region of the plantar fascia under ultrasound guidance.
Platelet-Rich Fibrin (PRF) - prepared from autologous venous blood by centrifugation without anticoagulants, forming a fibrin matrix injected into the plantar fascia under ultrasound guidance.
All procedures are performed under sterile conditions and tibial nerve regional anesthesia.
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, Investigator)
盲法说明
Double-blind design: both participants and investigators performing follow-up assessments are blinded to group allocation. The injectate is prepared in a separate room by a technician not involved in patient assessment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Clinical diagnosis of chronic plantar fasciitis for more than 6 months, confirmed by ultrasonography (increased plantar fascia thickness and hypoechogenicity).
- •Persistent heel pain refractory to conventional conservative treatment (stretching, orthotics, physical therapy, or corticosteroid injections).
- •Visual Analog Scale (VAS) pain score ≥ 4 at baseline.
- •Ability and willingness to comply with study procedures and follow-up assessments.
- •Signed informed consent.
排除标准
- •Previous foot or ankle surgery on the affected limb.
- •Acute trauma, infection, or ulceration in the region of the plantar fascia.
- •Systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, psoriatic arthritis).
- •Metabolic or endocrine disorders interfering with healing (e.g., diabetes mellitus with poor glycemic control, thyroid disorders).
- •Current use of systemic corticosteroids, immunosuppressants, or anticoagulants.
- •Active neoplasia or hematologic disorders.
- •Pregnancy or breastfeeding.
- •Peripheral vascular disease or neuropathy affecting the lower limbs.
- •Contraindications to local anesthesia or venipuncture.
研究组 & 干预措施
Bone Marrow Aspirate (BMA) Group
Participants receive a single ultrasound-guided injection of autologous bone marrow aspirate (approximately 8 mL) into/around the plantar fascia on one side, according to randomization.
Bone marrow aspirate is obtained from the posterosuperior iliac crest under local anesthesia and prepared under sterile conditions. The injection is performed after regional anesthesia of the tibial nerve using ultrasound guidance.
干预措施: Bone Marrow Aspirate Injection (Biological)
Platelet-Rich Fibrin (PRF) Group
Participants receive a single ultrasound-guided injection of autologous platelet-rich fibrin (PRF, approximately 8 mL) into/around the plantar fascia on the contralateral side, according to randomization.
PRF is prepared from 60 mL of venous blood centrifuged without anticoagulant to form a fibrin clot, which is injected into the painful area of the fascia after regional anesthesia of the tibial nerve under ultrasound guidance.
干预措施: Platelet-Rich Fibrin Injection (Biological)
结局指标
主要结局
Change in pain intensity (VAS) and occurrence of adverse events
时间窗: baseline (0), 30 minutes, 1, 6, 12, and 24 months
Pain intensity measured by Visual Analog Scale (VAS) and documentation of any adverse events, assessed at each time point by a blinded evaluator.
次要结局
- Change in Plantar Fascia Thickness by Ultrasound(Pre-procedure (baseline) and 12 months)
- Change in Modified AOFAS Score(baseline, 1, 6, 12, 24 months)
研究者
Rodrigo de Almeida Mastrorosa
Principal Investigator / PhD Candidate
Federal University of São Paulo