Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
13. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
75
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Visual Analogue Scale (VAS) Pain Score
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
1. november 2027
Datoer for studieregistrering
Først indsendt
13. september 2026
Først indsendt, der opfyldte QC-kriterier
13. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRF & PRP in Plantar Fasciitis
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