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

September 13, 2026 updated by: 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:

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Baxter's Nerve Pulsed Radiofrequency
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.
Active Comparator: 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.
Procedure: Autologous Platelet-Rich Plasma Injection
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.
Experimental: 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.
Procedure: Baxter's Nerve Pulsed Radiofrequency
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.
Procedure: Autologous Platelet-Rich Plasma Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Visual Analogue Scale (VAS) Pain Score
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 13, 2026

First Submitted That Met QC Criteria

September 13, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF & PRP in Plantar Fasciitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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