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Completed

NCT Number: NCT06737445

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kars Harakani State Hospital

Kars, Merkez, 36000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation alone

Procedure

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

Cortisone Injection

Procedure

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

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).

Primary outcomes

  1. Visual Analog Scale (VAS) scores

    Time frame: 1st month. 3rd month, 6th month

    Pain score (1 to 10 points)

  2. Foot Function Index (FFI)

    Time frame: 1st month. 3rd month, 6th month,

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

  3. Roles and Maudsley Score

    Time frame: 1st 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)

Sponsors and collaborators

Lead sponsor

Kars Harakani State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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