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

NCT ID: NCT06240507

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2023-09-01

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.

Conditions

Heel Spur; Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pulsed radiofrequency group

posterior tibial nerve pulsed radiofrequency for painful calcaneal spur and plantar fasciitis

Group Type: ACTIVE_COMPARATOR

ultrasound-guided posterior tibial nerve pulsed radiofrequency

Intervention Type: PROCEDURE

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

radiofrequency thermocoagulation group

intralesional radiofrequency thermocoagulation for painful calcaneal spur and plantar fasciitis

Group Type: ACTIVE_COMPARATOR

fluoroscopy-guided intralesional radiofrequency thermocoagulation

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Damla Yürük

Supervisor Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gevher Rabia Genc Perdecioğlu

Role: STUDY_CHAIR

Diskapi TRH

Locations

Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yildiz G, Perdecioglu GRG, Yuruk D, Can E, Akkaya OT. Comparison of tibial nerve pulsed radiofrequency and intralesional radiofrequency thermocoagulation in the treatment of painful calcaneal spur and plantar fasciitis: a randomized clinical trial. Pain Med. 2024 Aug 1;25(8):493-499. doi: 10.1093/pm/pnae029.

Reference Type: DERIVED

PMID: 38652568 (View on PubMed)

Other Identifiers

PTN PRF vs intralesional RFT

Identifier Type: -

Identifier Source: org_study_id