Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Chronic Plantar Fasciitis
Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial
Federal University of São Paulo
72 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria9
- 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.
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Interventions
Ultrasound-guided injection of autologous bone marrow aspirate obtained from the posterosuperior iliac crest under local anesthesia. Approximately 8mL of aspirate is injected into/around the plantar fascia.
Ultrasound-guided injection of autologous platelet-rich fibrin (PRF) prepared from 60 mL of venous blood centrifuged to form a fibrin clot. Approximately 8mL of PRF is injected into/around the plantar fascia.
Locations(1)
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NCT07242729