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Not yet recruitingNCT07826234Updated Sep 17, 2026

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

An interventional study of Baxter's Nerve Pulsed Radiofrequency and Autologous Platelet-Rich Plasma Injection in Plantar Fasciitis, Heel Pain and Nerve Compression Syndromes, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Fasciitis, Plantar

223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.

This study's planned enrollment of 75 is above the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Previous surgical intervention for plantar fasciitis
  • Previous radiofrequency ablation or neuromodulation around the foot or ankle
  • -rich plasma (PRP) injection within the previous 6 months
  • Local 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
  • or severe psychiatric illness
  • Inability or refusal to provide
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • 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

  • 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

  • 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 · Procedure: Autologous Platelet-Rich Plasma Injection

Interventions

  • ProcedureBaxter'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.

  • ProcedureAutologous 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.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 104 non-industry interventional studies with no phase under Fasciitis, Plantar, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 12 months is close to that.

Counting every sponsor, half of 109 studies reached it within 11 months; a quarter within 6 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2026
First posted
Sep 17, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Nov 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07826234
Lead sponsor
Assiut University
Responsible party
Noreen Ahmed Hamza Mohammed (Resident, Assiut University) — Principal investigator
First posted
Sep 17, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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