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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.
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.
Pain and safety will be monitored using the Visual Analog Scale (VAS) and by recording adverse events at the following time points: baseline (0), 30 minutes, 1, 6, 12, and 24 months after the procedure.
Functional outcomes will be collected with Modified AOFAS Score at baseline, 1, 6, 12, and 24 months. Ultrasonography will measure plantar fascia thickness immediately before the intervention and at 12 months.
This research contributes to the growing evidence supporting orthobiologic therapies as viable, minimally invasive options for chronic plantar fasciitis management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow Aspirate (BMA) Group | Experimental | 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. |
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| Platelet-Rich Fibrin (PRF) Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspirate Injection | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity (VAS) and occurrence of adverse events | Pain intensity measured by Visual Analog Scale (VAS) and documentation of any adverse events, assessed at each time point by a blinded evaluator. | baseline (0), 30 minutes, 1, 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified AOFAS Score | Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function. | baseline, 1, 6, 12, 24 months |
| Change in Plantar Fascia Thickness by Ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUCAS FONSECA, MD | Contact | +5511982148662 | contato@drlucasfonseca.med.br | |
| Carlos Franciozi, PhD | Contact | cacarlos66@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lucas Fonseca | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo - Hospital São Paulo | Recruiting | São Paulo | 04023-900 | Brazil |
De-identified individual participant data (IPD) that support the findings of this study will be made available upon reasonable request after publication of the main results. Data will be shared with qualified researchers for academic purposes only, upon approval by the principal investigator and the ethics committee.
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The IPD will be available beginning 6 months after publication and for up to 3 years thereafter.
Researchers must provide a methodologically sound proposal and obtain approval from the study's principal investigator (Lucas Fonseca, MD). Data access will be granted through a secure data transfer agreement.
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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Two-arm, parallel, randomized, controlled clinical trial comparing the effects of ultrasound-guided injection of Bone Marrow Aspirate versus Platelet-Rich Fibrin in patients with chronic plantar fasciitis.
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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.
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| Platelet-Rich Fibrin Injection | Biological | 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. |
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Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months.
| Pre-procedure (baseline) and 12 months |