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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gokhan Yildiz
- Phone Number: 5059272589
- Email: gkoyldz@gmail.com
Study Locations
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Ankara, Turkey
- Recruiting
- Diskapi Training and Research Hospital
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Contact:
- Gevher Rabia Genç Perdecioğlu
- Phone Number: TR 5332009184
- Email: gevhergenc@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Posterior Tibial Nerve PRF for Painful Calcaneal Fracture
posterior tibial nerve pulsed radiofrequency for painful calcaneal fracture
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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.
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Active Comparator: Control
control group for painful calcaneal fracture
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual analog scale (VAS)
Time Frame: Change from baseline to 3rd month after treatment
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VAS is a scale that can be used measuring pain.
Scores range from 0 (no pain) to 10 (the worst pain)
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Change from baseline to 3rd month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The American Orthopaedic Foot and Ankle Society (AOFAS)
Time Frame: Change from baseline to 3rd month after treatment
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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. |
Change from baseline to 3rd month after treatment
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Collaborators and Investigators
Investigators
- Study Chair: Gevher Rabia Genc Perdecioğlu, Diskapi TRH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTN-RF for calcaneal fracture
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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