Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:

NCT06737445 | Completed

• 1 other identifier: 27093
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal lesioning (RTL) in the management of chronic plantar fasciitis.

Conditions

Chronic Plantar Fasciitis

Keywords

extracorporeal shock wave therapy (ESWT); radiofrequency thermal lesioning (RTL); Chronic plantar fasciitis; corticosteroid injection (CSI)

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS) scores

  Pain score (1 to 10 points)

  1st month. 3rd month, 6th month

• Foot Function Index (FFI)

  Function score (The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.)

  1st month. 3rd month, 6th month,

• Roles and Maudsley Score

  The Roles and Maudsley score is an established subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pretreatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pretreatment)

  1st month. 3rd month, 6th month,

Study Arms (3)

Radiofrequency thermal lesioning (RTL)

ACTIVE COMPARATOR

RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).

Procedure: Radiofrequency ablation alone

Extracorporeal shock wave therapy (ESWT)

ACTIVE COMPARATOR

Patients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA).

Other: Extracorporeal shock wave therapy

Corticosteroid Injection

ACTIVE COMPARATOR

An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.

Procedure: Cortisone Injection

Interventions

Radiofrequency ablation alone PROCEDURE

RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).

Radiofrequency thermal lesioning (RTL)

Cortisone Injection PROCEDURE

An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.

Corticosteroid Injection

Extracorporeal shock wave therapy OTHER

Patients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA).

Extracorporeal shock wave therapy (ESWT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistant heel pain for ≥ 6 months
• No response to at least 6 weeks of conservative treatment (including at least two of the following: NSAIDs, stretching exercises, ice, heel pads, physical therapy, or night splints)
• Age ≥ 18
• BMI ≤ 35
• VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity
• Willingness to participate in the study

You may not qualify if:

• Previous foot or ankle surgery, major trauma
• Tumor, osteomyelitis, or complex regional pain syndrome in the affected limb
• Allergy to local anesthesia or NSAIDs
• Pregnancy or breastfeeding
• History of calcaneal fracture
• Previous cortisone injection, ESWT, or RTL for similar complaints
• BMI \>35
• Age \< 18
• Use of medications for neuropathic pain (Pregabalin, Gabapentin)
• Proximal nerve lesion (e.g., spinal stenosis, sciatica, tarsal tunnel syndrome)
• Regional skin or subcutaneous infections, fat pad atrophy
• History of rheumatic disease, or hematologic conditions
• History of peripheral vascular disease
• Seronegative arthropathies, heart failure, hepatic or metabolic disorders
• Pacemaker

Sponsors & Collaborators

• Kars Harakani State Hospital: lead

Study Sites (1)

Kars Harakani State Hospital

Kars, Merkez, 36000, Turkey (Türkiye)

Location

Related Publications (5)

• Erden T, Toker B, Cengiz O, Ince B, Asci S, Toprak A. Outcome of Corticosteroid Injections, Extracorporeal Shock Wave Therapy, and Radiofrequency Thermal Lesioning for Chronic Plantar Fasciitis. Foot Ankle Int. 2021 Jan;42(1):69-75. doi: 10.1177/1071100720949469. Epub 2020 Sep 3.

  PMID: 32880199 BACKGROUND

• Liden B, Simmons M, Landsman AS. A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis. J Foot Ankle Surg. 2009 Nov-Dec;48(6):642-7. doi: 10.1053/j.jfas.2009.05.013. Epub 2009 Jul 5.

  PMID: 19857819 BACKGROUND

• Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.

  PMID: 17400020 BACKGROUND

• Wu PT, Lee JS, Wu KC, Wu TT, Shao CJ, Liang FW, Chern TC, Su FC, Jou IM. Ultrasound-Guided Percutaneous Radiofrequency Lesioning When Treating Recalcitrant Plantar Fasciitis: Clinical Results. Ultraschall Med. 2016 Feb;37(1):56-62. doi: 10.1055/s-0034-1385466. Epub 2014 Nov 12.

  PMID: 25389914 BACKGROUND

• Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull. 2007;81-82:183-208. doi: 10.1093/bmb/ldm005. Epub 2007 Apr 24.

  PMID: 17456546 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Radiofrequency Ablation; Cortisone; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Physical Therapy Modalities; Rehabilitation

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: Medical Doctor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: April 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

TU (1)