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Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

Evaluation of the Effectiveness of Pulsed Radiofrequency Treatment of the Posterior Tibial Nerve in the Management of Chronic Plantar Pain Due to Calcaneal Fracture

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06888804
Enrollment
50
Registered
2025-03-21
Start date
2025-03-17
Completion date
2025-12-30
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcaneus Fracture

Keywords

Pulsed Radiofrequency Treatment, Tibial Nerve

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.

Interventions

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.

OTHERControl Group

No intervention

Sponsors

Diskapi Teaching and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
The American Orthopaedic Foot and Ankle Society (AOFAS)Change from baseline to 3rd month after treatmentThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactGokhan Yildiz
gkoyldz@gmail.com5059272589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026