Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this 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:

1. Baxter's nerve pulsed radiofrequency (PRF), a neuromodulation procedure designed to reduce nerve-related pain without destroying nerve fibers. 2. 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. 3. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baxter's Nerve Pulsed Radiofrequency

    Procedure/Surgery

    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.

  • Autologous Platelet-Rich Plasma Injection

    Procedure/Surgery

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group A: Baxter's Nerve Pulsed RadiofrequencyExperimental treatment 1 intervention
Group B: Group B: Platelet-Rich Plasma InjectionActive comparator 1 intervention
Group C: Group C: Combined PRF and PRP TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in Visual Analogue Scale (VAS) Pain Score

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.

Time frame
Baseline and 6 months post-intervention

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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