Clinical trial NCT06737445: Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:
Official title: Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: extracorporeal shock wave therapy (ESWT)
radiofrequency thermal lesioning (RTL)
Chronic plantar fasciitis
corticosteroid injection (CSI)
Lead sponsor: Kars Harakani State Hospital
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of CSI, ESWT and RTL for recalcitrant plantar fasciitis. In this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* History of clubfoot, pes cavus, or calcaneovalgus
* Diabetic neuropathy

Primary outcomes:
measure: Visual Analog Scale (VAS) scores
timeFrame: 1st month. 3rd month, 6th month
measure: Foot Function Index (FFI)
timeFrame: 1st month. 3rd month, 6th month,
measure: Roles and Maudsley Score
timeFrame: 1st month. 3rd month, 6th month,
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kars Harakani State Hospital
state: Merkez
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.