Bone Marrow Aspirate Versus Platelet-Rich Fibrin for the Treatment of Plantar Fasciitis - A Double-Blind Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Brazil
Federal University of São Paulo - Hospital São Paulo
RECRUITING
São Paulo
Contact Information
Primary
LUCAS FONSECA, MD
contato@drlucasfonseca.med.br
+5511982148662
Backup
Carlos Franciozi, PhD
cacarlos66@hotmail.com
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 72
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Federal University of São Paulo

This content was sourced from clinicaltrials.gov