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

NCT06240507 | Completed

• 1 other identifier: PTN PRF vs intralesional RFT
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Spur; Plantar Fascitis

Keywords

Pulsed Radiofrequency Treatment; Ultrasonography; Fluoroscopy; Tibial Nerve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score

  Change from baseline to 3rd month after treatment

Study Arms (2)

pulsed radiofrequency group

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequency

radiofrequency thermocoagulation group

ACTIVE COMPARATOR

intralesional radiofrequency thermocoagulation for painful calcaneal spur and plantar fasciitis

Procedure: fluoroscopy-guided intralesional radiofrequency thermocoagulation

Interventions

ultrasound-guided posterior tibial nerve pulsed radiofrequency 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

pulsed radiofrequency group

fluoroscopy-guided intralesional radiofrequency thermocoagulation 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.

radiofrequency thermocoagulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38652568 DERIVED

MeSH Terms

Conditions

Heel Spur

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: January 2, 2023
• Primary Completion: August 5, 2023
• Study Completion: September 1, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

TU (1)