Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDiskapi Teaching and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of calcaneal fracture

VAS score >5

Pain persisting for more than 3 months after the fracture

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided posterior tibial nerve pulsed radiofrequency

    Procedure/Surgery

    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.

  • Control Group

    Other intervention

    No intervention

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Posterior Tibial Nerve PRF for Painful Calcaneal FractureActive comparator 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual analog scale (VAS)

VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Time frame
Change from baseline to 3rd month after treatment

Secondary outcomes

1

The American Orthopaedic Foot and Ankle Society (AOFAS)

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.

Time frame
Change from baseline to 3rd month after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.