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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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)
- Conditions
- Chronic Planter Fascitis
- 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
locally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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 Receives: Procedure: Local percutaneous pulsed radiofrequency Ablation PRFA |
| Group B | Active comparator | locally 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.
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.
- First posted6 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Planter FascitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gamal Khafagy, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Percutaneous Pulsed Radiofrequency Ablation Versus Ultrasound Guided Steroids Injection in Management of Pain in Cases of Chronic Planter Fascitis, Randomised Double Blinded Study
- ClinicalTrials.gov ID
- NCT07394894
- Acronym / sponsor ID
- LPC RA VS US steroids
- Conditions
- Chronic Planter Fascitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Local percutaneous pulsed radiofrequency Ablation PRFALocal 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 |
| Group B | Active comparator | Drug: methylprednisolonelocally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Adult patients aged 18-65 years 2.ASA Physical Status I-II 3. patients diagnosed with chronic plantar fascitis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local percutaneous pulsed radiofrequency Ablation PRFALocal 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 | Procedure or surgery | Group A |
| methylprednisolonelocally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone) | Drug | Group B |
Primary outcome
severity of pain
Time frame: 24 hours after intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.