NCT06888804

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 17, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

Pulsed Radiofrequency TreatmentTibial Nerve

Outcome Measures

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)

    Change from baseline to 3rd month after treatment

Secondary Outcomes (1)

  • The American Orthopaedic Foot and Ankle Society (AOFAS)

    Change from baseline to 3rd month after treatment

Study Arms (2)

Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

ACTIVE COMPARATOR

posterior tibial nerve pulsed radiofrequency for painful calcaneal fracture

Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequency

Control

ACTIVE COMPARATOR

control group for painful calcaneal fracture

Other: Control Group

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.

Posterior Tibial Nerve PRF for Painful Calcaneal Fracture

No intervention

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of calcaneal fracture
  • VAS score \>5
  • Pain persisting for more than 3 months after the fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gevher Rabia Genc Perdecioğlu

    Diskapi TRH

    STUDY CHAIR

Central Study Contacts

Gokhan Yildiz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor Investigator

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

March 17, 2025

Primary Completion

September 25, 2025

Study Completion

December 30, 2025

Last Updated

April 11, 2025

Record last verified: 2025-04

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