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

Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: a Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06737445
Enrollment
49
Registered
2024-12-17
Start date
2021-04-01
Completion date
2023-02-01
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plantar Fasciitis

Keywords

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

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.

Interventions

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

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

OTHERExtracorporeal 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).

Sponsors

Kars Harakani State Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) scores1st month. 3rd month, 6th monthPain score (1 to 10 points)
Foot Function Index (FFI)1st month. 3rd month, 6th month,Function score (The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.)
Roles and Maudsley Score1st month. 3rd month, 6th month,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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026