Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

NCT ID: NCT06888804

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Calcaneus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

posterior tibial nerve pulsed radiofrequency for painful calcaneal fracture

Group Type ACTIVE_COMPARATOR

ultrasound-guided posterior tibial nerve pulsed radiofrequency

Intervention Type 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.

Control

control group for painful calcaneal fracture

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

No intervention

Interventions

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ultrasound-guided posterior tibial nerve pulsed radiofrequency

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.

Intervention Type PROCEDURE

Control Group

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

Supervisor Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gevher Rabia Genc Perdecioğlu

Role: STUDY_CHAIR

Diskapi TRH

Locations

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Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gokhan Yildiz

Role: CONTACT

5059272589

Facility Contacts

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Gevher Rabia Genç Perdecioğlu

Role: primary

5332009184 ext. TR

Other Identifiers

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PTN-RF for calcaneal fracture

Identifier Type: -

Identifier Source: org_study_id

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