Plantar Fasciitis
Conditions
Keywords
Plantar Fasciitis; Bone Marrow Aspirate; Platelet-Rich Fibrin; Ultrasound-Guided Injection; Regenerative Medicine
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALBone Marrow Aspirate Injection
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.
BIOLOGICALPlatelet-Rich Fibrin Injection
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.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (VAS) and occurrence of adverse events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified AOFAS Score | baseline, 1, 6, 12, 24 months | Improvement in the American Orthopaedic Foot and Ankle Society (AOFAS) score compared to baseline, reflecting pain and function. |
| Change in Plantar Fascia Thickness by Ultrasound | Pre-procedure (baseline) and 12 months | Variation in plantar fascia thickness (in millimeters) evaluated by ultrasound before the procedure and at 12 months. |
Countries
Brazil
Contacts
Primary ContactLUCAS FONSECA, MD
Backup ContactCarlos Franciozi, PhD
Outcome results
None listed