Posterior Tibial Nerve PRF vs Intralesional RFT for Painful Calcaneal Spur and Plantar Fasciitis

Plantar Fascitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240507
• Other study ID #: PTN PRF vs intralesional RFT
• Status: Completed
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 1, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Heel Spur
• Plantar Fascitis

Intervention

Procedure:
• ultrasound-guided posterior tibial nerve pulsed radiofrequency
The posterior tibial nerve (PTN) was identified with a 5-12 MHz linear ultrasonography (US) probe at the level of the medial malleolus, where it runs posterior to the posterior tibial artery. Using the in-plane technique, a 22-gauge, 10-cm radiofrequency cannula was inserted under US guidance and advanced until the tip was adjacent to the nerve. Pulse radiofrequency was applied at 42°C for 240 s with a pulse width of 20 ms
• fluoroscopy-guided intralesional radiofrequency thermocoagulation
The painful heel and calcaneal spur were visualized under lateral fluoroscopy. A 22-gauge, 10-cm radiofrequency cannula was inserted and advanced until the needle tip reached the calcaneal spur tip. When the needle tip contacted the spur, local anesthetic was administered through the cannula and radiofrequency ablation was performed at 80°C for 90 s.

Locations

Country	Name	City	State
Turkey	Diskapi Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale (NRS)	NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)	Change from baseline to 1st and 3rd month after treatment
Secondary	The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score	The AOFAS ankle-hindfoot score is used to measure the treatment outcome for ankle and hindfoot problems. It consists of three parts: pain, function, and alignment. Pain is worth 40 points, function is worth 50 points, and alignment is worth 10 points. The total score ranges from 0 to 100, with higher scores indicating better outcomes.	Change from baseline to 3rd month after treatment