Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 11:39 PM
Study NCT ID:
NCT06888804
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Tibial Nerve PRF for Painful Calcaneal Fracture
Sponsor:
Diskapi Teaching and Research Hospital
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: