Clinical trial NCT06888804: Posterior Tibial Nerve PRF for Painful Calcaneal Fracture
Official title: Evaluation of the Effectiveness of Pulsed Radiofrequency Treatment of the Posterior Tibial Nerve in the Management of Chronic Plantar Pain Due to Calcaneal Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcaneus Fracture
Keywords: Pulsed Radiofrequency Treatment
Tibial Nerve
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Change from baseline to 3rd month after treatment
Secondary outcomes:
measure: The American Orthopaedic Foot and Ankle Society (AOFAS)
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: