One Cause of Heel Pain is Plantar Fasciopathy (PF). In Most Cases, a Heel Spur is Frequently Present Alongside PF. We Aim to Evaluate the Efficacy of Corticosteroid Injection and Radiofrequency Ablation, Along With Tissue Elasticity Assessed by Ultrasound, in Patients With Chronic Pain (≥6 Months).

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTC Erciyes University

About this trial

Heel pain is common among adults. One cause of heel pain is plantar fasciopathy (PF). In most cases, a heel spur, a bony prominence that extends into the plantar fascia, is frequently present alongside PF. First-line treatments include pain-relieving drugs, home exercises, heel support peds, and physical therapy. However, some patients can't get relief from these therapies, and the pain persists beyond six months. This situation is referred to as refractory chronic PF. Local treatments applied via skin puncture such as anti-inflamtory injection and destruction of nerves carrying pain signals to brain are warranted in these cases. We aim to evaluate the efficacy of corticosteroid injection and radiofrequency ablation, along with tissue elasticity assessed by ultrasound, in patients with chronic pain (≥6 months).

The goal of this clinical trial is to determine which treatment-corticosteroid injection or radiofrequency thermal thermocoagulation-is more effective for treating plantar fasciopathy in adults. It will also learn about the effects of the treatments on the properties of the heel tissue using ultrasound. The main questions it aims to answer are:

Do corticosteroid injections and radiofrequency thermal thermocoagulation have the same efficacy on pain and functionality for both short- and long-term? Do corticosteroid injections and radiofrequency thermal thermocoagulation similarly affect heel tissue? The researchers will investigate which of the corticosteroid injection and radiofrequency thermocoagulation is more effective for

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with chronic (≥ 6 months) plantar fasciopathy

NRS score ≥ 4

Presence of a calcaneal spur detected by ultrasound (USG) or direct radiography

Home exercise program

Disqualifiers

History of calcaneal trauma/fracture

Previous radiofrequency ablation (RFA) treatment

Patients with seronegative spondyloarthropathy

Inflammatory or degenerative arthropathies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Corticosteroid Injection

    Drug

    The symptomatic foot will be prepared with povidone-iodine and draped in a sterile manner. A sterile-covered ultrasound probe will be placed over the heel to visualize the calcaneus, plantar fascia, and any calcaneal spur. Subsequently, 1 mL of triamcinolone acetonide 40 mg (KENACORT-A IM/Intra-articular Retard 40 mg ampoule) and 1 mL of 2% lidocaine (Aritmal 2% ampoule) will be injected over the plantar fascia.

  • Radiofrequency thermocoagulation

    Procedure/Surgery

    The patient will be in the lateral decubitus position with the symptomatic foot below. The foot was prepared with povidone-iodine and draped under sterile conditions. A sterilized ultrasound probe was placed over the heel to visualize the calcaneus, plantar fascia, and calcaneal spur. A 10 cm long radiofrequency (RF) needle with a 5 mm active tip was advanced in-plane under ultrasound guidance toward the tip of the calcaneal spur. Sensory stimulation at 50 Hz elicited paresthesia in the medial calcaneus, while motor stimulation at 2 Hz did not produce any muscle contractions. The RF generator (Beijing Neo Science Co., RFE 4b) was set to 80 °C for 90 seconds, and the RFA procedure was initiated.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Corticosteroid InjectionActive comparator 1 intervention
Group B: Radiofrequency ThermocoagulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Foot Function Index Score (FFI)

FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better.

Time frame
6 months after treatment

Secondary outcomes

1

Numeric Rating Scale-11 (NRS-11) Scores

NRS-11 is an 11-point Likert-type scale that assesses pain severity. The lowest score is 0, and the highest score is 10. A lower score is better

Time frame
6 months after treatment

Other outcomes

1

Foot Function Index (FFI)

FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better

Time frame
1 month after treatment
2

Foot Function Index (FFI)

FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better

Time frame
Baseline
3

Foot Function Index (FFI)

FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better

Time frame
3 months after treatment
4

Numeric Rating Scale-11 (NRS-11) Scores

NRS-11 is an 11-point Likert-type scale that assesses pain severity. The lowest score is 0, and the highest score is 10. A lower score is better

Time frame
Baseline

Sponsors and contacts

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