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).

NCT07120204 | Not Yet Recruiting

• 1 other identifier: 2025/60
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plantar Fasciopathy; Chronic Pain; Corticosteroid Injection; Radiofrequency Ablation; Elasticity Imaging Techniques

Keywords

plantar fasciopathy; plantar fasciitis; randomized; radiofrequency thermal coagulation; RF; shear wave; elastography

Outcome Measures

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.

  6 months after treatment

Secondary Outcomes (1)

• Numeric Rating Scale-11 (NRS-11) Scores

  6 months after treatment

Other Outcomes (6)

• Foot Function Index (FFI)

  1 month after treatment

• Foot Function Index (FFI)

  Baseline

• Foot Function Index (FFI)

  3 months after treatment

Study Arms (2)

Corticosteroid Injection

ACTIVE COMPARATOR

The patient will be in the lateral decubitus position with the symptomatic foot below. 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.

Drug: Corticosteroid Injection

Radiofrequency Thermocoagulation

ACTIVE COMPARATOR

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.

Procedure: Radiofrequency thermocoagulation

Interventions

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.

Corticosteroid Injection

Radiofrequency thermocoagulation PROCEDURE

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.

Radiofrequency Thermocoagulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic (≥ 6 months) plantar fasciopathy
• NRS score ≥ 4
• Presence of a calcaneal spur detected by ultrasound (USG) or direct radiography
• At least one of the following treatments has been administered:
• Home exercise program
• Physiotherapy
• Orthosis/prosthesis
• NSAIDs
• Night splint
• Kinesio taping
• Corticosteroid injection
• Extracorporeal shock wave therapy (ESWT)

You may not qualify if:

• History of calcaneal trauma/fracture
• Previous radiofrequency ablation (RFA) treatment
• Patients with seronegative spondyloarthropathy
• Inflammatory or degenerative arthropathies
• Presence of diabetes
• Pregnancy
• History of cancer
• Peripheral neuropathy or ischemia
• Open wound or signs of infection at the procedure site
• Evidence of systemic infection
• Patients using anticoagulant or antiplatelet agents
• Presence of an intracardiac defibrillator or pacemaker
• Patients with tarsal tunnel syndrome
• Patients who have received ESWT and/or corticosteroid injection within the last 3 months
• Presence of heel pain due to lumbar radiculopathy

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, Talas, Turkey (Türkiye)

Location

Related Publications (1)

• Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.

  PMID: 18524985 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gülen Güler, Prof. Dr., M.D.

  Erciyes Üniversity School of Medicine, Anesthesiology and Reanimation Department

  STUDY DIRECTOR

Central Study Contacts

Ersin Sönmez, M.D.

CONTACT

+905370257858; ersinsonmez@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor, Head of Anesthesiology and Reanimation Deparment, Head of Algology Department

Model Details: Randomized, Open-Label Study

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 1 year after the study is completed.

Locations

TU (1)