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Chronic Planter FascitisPhase 4NCT07394894

Local Percutaneous Pulsed Radiofrequency Ablation Versus Ultrasound Guided Steroids Injection in Management of Pain in Cases of Chronic Planter Fascitis, Randomised Double Blinded Study

A Phase 4 study testing Local percutaneous pulsed radiofrequency Ablation PRFA and methylprednisolone in people with Chronic Planter Fascitis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Plantar fasciitis is the one of the most common causes of painful heel in adults. It is assumed to be caused by inflammation and is typically precipitated by biomechanical stress. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Planter Fascitis
What is being tested?
Local percutaneous pulsed radiofrequency Ablation PRFA and methylprednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
No sites listed yet
Study dates
Mar 2026to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Adult patients aged 18-65 years 2.ASA Physical Status I-II 3. patients diagnosed with chronic plantar fascitis

Who cannot join

  • 1.patient refusal 2.Allergy to any study drug 3.pregnant , lactating women 4.Having undergone a prior surgery in the heel area/region 5.Having a history of trauma or fracture of the calcaneus 6.Having peripheral vascular ischemia 7.Having peripheral neuropathy and radiculopathy proven by electromyography or physical examination 8.Having calcaneal lesions, including benign tumors 9.Having an open wound or infection in the heel area/region 10.Having severe fat pad atrophy, calcaneal bursitis, and skin abnormalities around the heel 11.Having severe arthritic changes 12. bleeding disorder or on anti coagulant therapy

About this study

Plantar fasciitis is the one of the most common causes of painful heel in adults. It is assumed to be caused by inflammation and is typically precipitated by biomechanical stress. It is very difficult to treat this condition as the causation is not exactly diagnosed (1) Plantar fascia is a broad band of fibrous tissue which originates from the anteromedial plantar aspect of the calcaneal tuberosity and inserts through several slips into the plantar aspects of the metatarsophalangeal joints, the flexor tendon sheaths, and the bases of the proximal phalanges of the digits. Athletic population has a high frequency of plantar fasciitis and in the non-athletic population it is most frequently seen in weight bearing occupations (2) Excessive pulling and stretching of plantar fascia either from excessive exercise or overuse, repeated trauma, aging, obesity, poor fitting shoe gear or poor foot alignment while running or prolong standing, produce microscopic tear of collagen or cystic degeneration in the origin of plantar fascia causing pain and inflammation.(3) Planter Fasciitis is considered a self limited condition. However, the long interval is frustrating for both patients and clinicians. Although, there are numerous reports describing operative and non-operative treatment options that claim to hasten the resolution of symptoms, few entail high level evidence to substantiate their claims. Without high quality data to identify which treatments are successful, the clinical decision making in the management of this condition is at times arbitrary and anecdotal (4) 3 The classic presentation of plantar fasciitis is pain on the sole of foot at the inferior region of the heel which is particularly worse with the first step taken after bed (5) Noninvasive Treatments PF is usually a self-limiting condition, with more than 90% of patients achieving symptomatic relief with 3-6 months of conservative treatment. 39 Initial treatment should consist of nonsteroidal antiinflammatories (NSAIDs), stretching of the gastrocnemius and the plantar fascia, and the use of an orthosis (heel pads, heel cups, arch supports, or night splints). Successful treatment is defined as a decrease in pain and improvement in function. Minimally Invasive Treatments Patients with heel pain for 6 months or more that is recalcitrant to the nonoperative treatments may undergo minimally invasive procedures that relieve pain (corticosteroid injection), decrease heel cord tightness (botulinum toxin injection), or stimulate the body's healing response (platelet rich plasma [PRP] injection, dry needling, extracorporeal shock wave therapy (ESWT), intense therapeutic ultrasound). Operative treatment is indicated when pain and functional limitations persist despite an adequate nonoperative trial lasting at least 6 months (Partial Plantar Fasciotomy-Gastrocnemius Lengthening) Radiofrequency (RF) that aims to reduce pain by targeting nerves . There are two main types: thermal RF ablation, which uses heat to damage nerve endings, and pulsed RF ablation, which uses less heat to desensitize nerves with a lower risk of complications. radiofrequency ablation (RFA) has emerged as a minimally invasive technique for the treatment of recalcitrant plantar fasciitis. RFA aims to disrupt pain transmission by targeting nerve tissue . There are two types of RFA: thermal radiofrequency ablation (TRFA) and pulse radiofrequency ablation (PRFA). TRFA involves the use of high temperatures to desensitize nerve endings, aiming to reduce pain by disrupting pain 4 signal transmission. However, the use of high temperatures carries a risk of damaging surrounding tissues, potentially leading to side effects and complications . PRFA, on the other hand, utilizes low-temperature pulsed electric fields to achieve nerve ablation in a less invasive manner. PRFA's neurodestructive effects are minimal, reducing pain without damaging surrounding soft tissues. The relatively long pauses between pulses in PRFA prevent excessive heating of nerve tissue, thus providing pain management without causing nerve damage. Compared to thermal RFA, PRFA has a minimal risk of causing neuritis, neuroma, and deafferentation pain(6) Steroids is a corticosteroid with potent anti-inflammatory and analgesic properties.

It has been shown to prolong the duration of sensory block and reduce postoperative nausea and vomiting (7)

Being tested
Local percutaneous pulsed radiofrequency Ablation PRFA, methylprednisolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local percutaneous pulsed radiofrequency Ablation PRFAProcedure or surgery

    Local percutaneous pulsed radiofrequency Ablation PRFA was applied at 42 °C for eight minutes at 20 m/s intervals, aiming for an impedance of 250-500 ohms

  • methylprednisoloneDrug

    locally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone)

Study groups in NCT07394894
Study groupRoleWhat they receive
Group AActive comparatorLocal percutaneous pulsed radiofrequency Ablation PRFA was applied at 42 °C for eight minutes at 20 m/s intervals, aiming for an impedance of 250-500 ohms
Receives: Procedure: Local percutaneous pulsed radiofrequency Ablation PRFA
Group BActive comparatorlocally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone)
Receives: Drug: methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. severity of pain

    NRS score can refer to a Numerical Rating Scale for pain , using a scale of 0-10 to measure severity, 0: No pain ,1-3: Mild , 4-6: Moderate and 7-10: Severe

    Measured: 24 hours after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394894
Sponsor's protocol ID
LPC RA VS US steroids
Status last verified
Jan 2026
First submitted
31 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Local percutaneous pulsed radiofrequency Ablation PRFA and methylprednisolone in people with Chronic Planter Fascitis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

severity of pain (time frame: 24 hours after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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