Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
13 september 2026 bijgewerkt door: Noreen Ahmed Hamza Mohammed, Assiut University
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis: Randomized Controlled Trial
Plantar fasciitis is a common condition causing chronic heel pain due to degenerative changes in the tissue supporting the arch of the foot. While most patients improve with conservative care such as physical therapy, anti-inflammatory medications, and orthotics, approximately 10% to 20% experience chronic pain that fails to respond to standard measures. In up to 20% of these persistent cases, irritation or entrapment of the first branch of the lateral plantar nerve (Baxter's nerve) also plays a key role in the pain.
The purpose of this study is to compare the safety and effectiveness of three ultrasound-guided interventional approaches for treating chronic recalcitrant plantar fasciitis:
- Baxter's nerve pulsed radiofrequency (PRF), a neuromodulation procedure designed to reduce nerve-related pain without destroying nerve fibers.
- Platelet-rich plasma (PRP) injection, an autologous blood-derived preparation that delivers natural growth factors to stimulate tissue healing and repair of the plantar fascia.
- Combined PRF and PRP therapy, addressing both nerve irritation and structural tissue degeneration simultaneously.
A total of 75 adult patients aged 18 to 65 years with recalcitrant plantar fasciitis persisting for over 6 months will be randomly assigned into three equal groups (25 patients per group). Participants and independent clinical assessors will be blinded to treatment allocation. Patients will be followed for 6 months to evaluate pain reduction, functional recovery, plantar fascia thickness measured by ultrasound, and procedure safety.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
75
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 18 to 65 years.
- Clinical diagnosis of recalcitrant plantar fasciitis with symptoms persisting for more than 6 months despite conservative treatment.
- Failure of conventional non-surgical therapy (including activity modification, NSAIDs, stretching exercises, physiotherapy, and foot orthoses) for at least 3 months.
- Morning heel pain localized to the medial calcaneal tubercle.
- Local tenderness upon palpation over the medial calcaneal tubercle.
- Plantar fascia thickness greater than 4 mm confirmed by musculoskeletal ultrasound.
- Ability to understand the study protocol and provide written informed consent.
Exclusion Criteria:
- Previous surgical intervention for plantar fasciitis
- Previous radiofrequency ablation or neuromodulation around the foot or ankle
- Platelet-rich plasma (PRP) injection within the previous 6 months
- Local corticosteroid injection within the previous 3 months
- Evidence of calcaneal stress fracture
- Coexisting tarsal tunnel syndrome or history of Baxter's nerve surgery
- Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, reactive arthritis)
- Pregnancy
- Active local (foot/ankle) or systemic infection
- Coagulopathy, bleeding disorders, or ongoing anticoagulant therapy that cannot be safely interruptedMalignancy or severe psychiatric illness
- Malignancy or severe psychiatric illness
- Inability or refusal to provide informed consent
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A: Baxter's Nerve Pulsed Radiofrequency
Participants receive ultrasound-guided pulsed radiofrequency (PRF) targeting Baxter's nerve (the first branch of the lateral plantar nerve).
The procedure is performed under complete aseptic technique at 42°C, with a pulse width of 20 ms, a frequency of 2 Hz, for a duration of 8 minutes.
|
Ultrasound-guided pulsed radiofrequency (PRF) targeting Baxter's nerve (the first branch of the lateral plantar nerve) performed under sterile aseptic precautions.
Parameters applied: target temperature of 42°C, pulse width of 20 ms, frequency of 2 Hz, for a total duration of 8 minutes.
|
|
Actieve vergelijker: Group B: Platelet-Rich Plasma Injection
Participants receive an ultrasound-guided injection of 5 mL autologous platelet-rich plasma (PRP) into the diseased plantar fascia.
PRP is prepared via a standardized double-spin centrifugation technique and administered under complete aseptic precautions.
|
Ultrasound-guided administration of 5 mL autologous platelet-rich plasma (PRP) directly into the hypoechoic, thickened portion of the diseased plantar fascia.
PRP is isolated using a standardized double-spin centrifugation protocol and injected under complete aseptic conditions.
|
|
Experimenteel: Group C: Combined PRF and PRP Therapy
Participants receive combined treatment consisting of ultrasound-guided Baxter's nerve pulsed radiofrequency (42°C, 20 ms pulse width, 2 Hz for 8 minutes) followed by ultrasound-guided autologous platelet-rich plasma injection (5 mL) into the diseased plantar fascia under complete aseptic technique.
|
Ultrasound-guided pulsed radiofrequency (PRF) targeting Baxter's nerve (the first branch of the lateral plantar nerve) performed under sterile aseptic precautions.
Parameters applied: target temperature of 42°C, pulse width of 20 ms, frequency of 2 Hz, for a total duration of 8 minutes.
Ultrasound-guided administration of 5 mL autologous platelet-rich plasma (PRP) directly into the hypoechoic, thickened portion of the diseased plantar fascia.
PRP is isolated using a standardized double-spin centrifugation protocol and injected under complete aseptic conditions.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Visual Analogue Scale (VAS) Pain Score
Tijdsspanne: Baseline and 6 months post-intervention
|
Pain intensity is assessed using the Visual Analogue Scale (VAS), where patients rate their heel pain on a 0 to 10 scale (0 = no pain, 10 = worst imaginable pain).
Lower scores indicate less pain and better clinical improvement.
The score change will be calculated as the post-treatment score minus the baseline score.
|
Baseline and 6 months post-intervention
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 oktober 2027
Studie voltooiing (Geschat)
1 november 2027
Studieregistratiedata
Eerst ingediend
13 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2026
Eerst geplaatst (Werkelijk)
17 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
13 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRF & PRP in Plantar Fasciitis
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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