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Clinical Trials/NCT06240507
NCT06240507
Completed
Not Applicable

Comparison of Ultrasound-guided Posterior Tibial Nerve Pulsed Radiofrequency and Fluoroscopy-guided Intralesional Radiofrequency Thermocoagulation in the Treatment of Painful Calcaneal Spur and Plantar Fasciitis

Diskapi Teaching and Research Hospital1 site in 1 country49 target enrollmentJanuary 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heel Spur
Sponsor
Diskapi Teaching and Research Hospital
Enrollment
49
Locations
1
Primary Endpoint
Numerical rating scale (NRS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study aims to compare the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) and fluoroscopy (FL)-guided intralesional radiofrequency thermocoagulation (RFT) for the treatment of painful calcaneal spur and plantar fasciitis refractory to conservative treatments. For this evaluation, a numerical rating (NRS) and the American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scores will be used before and after both interventions.

Detailed Description

Painful calcaneal spurs (PCS) and plantar fasciitis (PF) are common foot conditions affecting approximately 10-15% of the population. These conditions can cause severe heel pain and disability, affecting the patients' quality of life and productivity. Treatment of these conditions is complex and sometimes resistant to conventional therapies, such as rest, ice, stretching, orthotics, and anti-inflammatory drugs. Some studies have shown that conservative treatments can improve PCS and PF symptoms within 12 months. However, if conservative treatments fail, interventional procedures such as corticosteroid injections, radiofrequency ablation, or surgery may be used on the PCS and surrounding nerves. PRF and RFT are two modalities of thermal ablation that can be used to treat chronic pain conditions. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation, and can promote thinning of hard tissues, such as calcaneal spurs and plantar fascia. The PTN is a branch of the sciatic nerve that provides sensory and motor innervation to the heel and sole of the foot, where calcaneal spurs and PF occur. The advantage of the PTN over its smaller branches is that it can be visualized and targeted using US. FL can visualize PCS. US-guided PTN PRF and FL-guided intralesional RFT for pain management in PCS and PF have been used in a limited number of studies; however, no studies have compared their efficacy and adverse event rates. The primary aim of this study was to compare the efficacy of these two treatment modalities. The secondary aim was to determine the incidence of adverse events associated with US-guided PTN PRF and FL-guided intralesional TRF treatment. A total of at least 46 patients, 23 patients in each group, will be enrolled for comparison. NRS, and AOFAS scores before, 1 month, and 3 months after treatment will be compared both within and between groups.

Registry
clinicaltrials.gov
Start Date
January 2, 2023
End Date
September 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Damla Yürük

Supervisor Investigator

Diskapi Teaching and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Heel pain for at least 6 months consistent with clinical examination and imaging methods
  • Numeric rating scale (NRS) in the first few steps in the morning ≥ 6
  • Plantar fascia thicker than 4 mm as measured by ultrasonography
  • Demonstration of calcaneal spur by X-ray
  • Non-response to at least two of the indicated conservative treatments (rest, stretching exercises, oral anti-inflammatory drugs, silicone heel cup, local steroid injection, extracorporeal shock wave therapy (ESWT))

Exclusion Criteria

  • Achilles tendinopathy or calcaneal fracture
  • Inflammatory or degenerative arthritis
  • Spondyloarthropathies
  • Tarsal tunnel syndrome (confirmed by electromyography if clinically suspected)
  • Previous surgery on the plantar fascia or heel
  • Diabetes mellitus, peripheral neuropathies, peripheral ischemic disease
  • History of malignancy, pregnancy
  • Anticoagulant-anticoaggregant drug use or coagulopathy

Outcomes

Primary Outcomes

Numerical rating scale (NRS)

Time Frame: Change from baseline to 1st and 3rd month after treatment

NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcomes

  • The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score(Change from baseline to 3rd month after treatment)

Study Sites (1)

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