- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394894
Local Percutaneous Pulsed Radiofrequency Ablation Versus Ultrasound Guided Steroids Injection in Management of Pain in Cases of Chronic Planter Fascitis, Randomised Double Blinded 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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1.Adult patients aged 18-65 years 2.ASA Physical Status I-II 3. patients diagnosed with chronic plantar fascitis
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
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
|
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
|
|
Active Comparator: Group B
locally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone)
|
locally injection of steroids under ultrasound guided in planter fascitis ( 1ml containing 40 mg methylprednisolone)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPC RA VS US steroids
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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