Clinical trial NCT06240507: Posterior Tibial Nerve PRF vs Intralesional RFT for Painful Calcaneal Spur and Plantar Fasciitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heel Spur
Plantar Fascitis
Keywords: Pulsed Radiofrequency Treatment
Ultrasonography
Fluoroscopy
Tibial Nerve
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Change from baseline to 1st and 3rd month after treatment
Secondary outcomes:
measure: The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score
timeFrame: Change from baseline to 3rd month after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
Study officials:
affiliation: Diskapi TRH
name: Gevher Rabia Genc Perdecioğlu
role: STUDY_CHAIR
References: