Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

Not Applicable

Recruiting

• Conditions: Calcaneus Fracture

• Registration Number: NCT06888804
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

Patients who underwent pulsed radiofrequency (PRF) treatment of the posterior tibial nerve under ultrasound guidance, which is routinely performed in our clinic for severe heel pain following a calcaneal fracture, were evaluated through interviews. The assessment was conducted using the Visual Analog Scale (VAS) for pain and the American Orthopaedic Foot and Ankle Society (AOFAS) score.

Detailed Description

Pain following a calcaneal fracture can arise from direct injury, traction injury, idiopathic mechanisms such as reflex sympathetic dystrophy/complex regional pain syndrome (CRPS), or nerve damage. Since there is no single standardized definition or diagnosis for post-surgical nerve pain, such cases are described in the literature as neurapraxia, postoperative neuroma, unexplained heel pain, hypersensitive scar, or CRPS. Typically, this type of pain manifests as burning, paresthesia, dysesthesia, and hyperesthesia.

The tibial nerve plays a crucial role in the sensory and motor innervation of the heel. Following a calcaneal fracture, direct nerve injury, compression, or inflammation of the surrounding tissues may contribute to pain. Pulsed radiofrequency (PRF) has been shown to alleviate chronic pain by delivering an electrical field to the nerve tissue at a controlled temperature of \<42°C without causing nerve damage. Additionally, there is evidence supporting PRF's effectiveness in pain relief for patients with various chronic conditions.

In our study, the investigators aim to evaluate patients with persistent pain after a calcaneal fracture who have undergone PRF treatment of the posterior tibial nerve. By monitoring these patients immediately after the intervention, we will assess changes in their pain scores. Additionally, the investigators will compare them to patients with post-calcaneal fracture pain who have opted not to undergo the procedure.

Study Timeline

• Study Start: 2025-03-17
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-09-25
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• History of calcaneal fracture
• VAS score >5
• Pain persisting for more than 3 months after the fracture

Exclusion Criteria

• Presence of other foot pain-causing conditions (e.g., plantar fasciitis, heel spur)
• Additional fractures other than the calcaneus
• Pregnancy
• Coagulopathy or use of antiplatelet medications
• Mental illness impairing decision-making ability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Change from baseline to 3rd month after treatment	VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcome Measures

Name	Time	Method
The American Orthopaedic Foot and Ankle Society (AOFAS)	Change from baseline to 3rd month after treatment	The American Orthopaedic Foot and Ankle Society (AOFAS) score is evaluated under three subcategories: pain, function, and alignment. It includes both objective (function and alignment) and subjective (pain) data. Patients report their pain levels, which are then scored by physicians. Additionally, patients and doctors collaborate to complete the functional and alignment assessments.; Scores range from 0 to 100, with 100 representing a healthy patient. This scoring system will be assessed pre-procedure, on the day of the procedure, and at the 3-month follow-up.

Trial Locations

Locations (1)

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey