Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:
NCT ID: NCT06737445
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2021-04-01
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency thermal lesioning (RTL)
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Radiofrequency ablation alone
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Extracorporeal shock wave therapy (ESWT)
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
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).
Corticosteroid Injection
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.
Cortisone Injection
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.
Interventions
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Radiofrequency ablation alone
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Cortisone Injection
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.
Extracorporeal shock wave therapy
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* History of clubfoot, pes cavus, or calcaneovalgus
* Diabetic neuropathy
18 Years
75 Years
ALL
No
Sponsors
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Kars Harakani State Hospital
OTHER
Responsible Party
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Erdem Sahin
Medical Doctor
Locations
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Kars Harakani State Hospital
Kars, Merkez, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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27093
Identifier Type: -
Identifier Source: org_study_id