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

NCT07826234 | Not Yet Recruiting

• 1 other identifier: PRF & PRP in Plantar Fasciitis
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Baxter's nerve pulsed radiofrequency (PRF), a neuromodulation procedure designed to reduce nerve-related pain without destroying nerve fibers.
2. 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. 3.Combined PRF and PRP therapy, addressing both nerve irritation and structural tissue degeneration simultaneously.

Conditions

Plantar Fasciitis; Heel Pain; Nerve Compression Syndromes

Keywords

Pulsed Radiofrequency; Platelet-Rich Plasma; Baxter's Nerve; First Branch of Lateral Plantar Nerve; Recalcitrant Plantar Fasciitis; Ultrasound Guidance; Neuromodulation

Outcome Measures

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.

  Baseline and 6 months post-intervention

Study Arms (3)

Group A: Baxter's Nerve Pulsed Radiofrequency

EXPERIMENTAL

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.

Procedure: Baxter's Nerve Pulsed Radiofrequency

Group B: Platelet-Rich Plasma Injection

ACTIVE COMPARATOR

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.

Procedure: Autologous Platelet-Rich Plasma Injection

Group C: Combined PRF and PRP Therapy

EXPERIMENTAL

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.

Procedure: Baxter's Nerve Pulsed Radiofrequency; Procedure: Autologous Platelet-Rich Plasma Injection

Interventions

Baxter's Nerve Pulsed Radiofrequency PROCEDURE

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.

Group A: Baxter's Nerve Pulsed Radiofrequency; Group C: Combined PRF and PRP Therapy

Autologous Platelet-Rich Plasma Injection PROCEDURE

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.

Group B: Platelet-Rich Plasma Injection; Group C: Combined PRF and PRP Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Fasciitis, Plantar; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09