Effect of Additional Sural Nerve PRF in Chronic Heel Pain

August 13, 2026 updated by: Damla Yürük, Diskapi Teaching and Research Hospital

Does Targeting the Sural Nerve in Addition to the Posterior Tibial Nerve Increase the Effectiveness of Pulsed Radiofrequency Treatment in Chronic Plantar Heel Pain?

This observational study aims to compare the effectiveness of pulsed radiofrequency (PRF) treatment applied to the posterior tibial nerve alone versus PRF applied to both the posterior tibial and sural nerves in patients with chronic plantar heel pain. Outcomes will be assessed using the Visual Analog Scale (VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score at baseline, 1 month, and 3 months after treatment.

Study Overview

Detailed Description

This prospective observational cohort study evaluates whether the addition of sural nerve pulsed radiofrequency (PRF) to posterior tibial nerve PRF is associated with greater clinical improvement in patients with chronic plantar heel pain. In routine clinical practice, ultrasound-guided PRF is applied to the posterior tibial nerve, and in selected patients, additional PRF of the sural nerve is performed based on clinical judgment.

Patients are prospectively followed in two groups according to the treatment received: posterior tibial nerve PRF alone and posterior tibial nerve PRF combined with sural nerve PRF. Clinical outcomes are assessed at baseline and at 1 and 3 months after the procedure. Pain intensity is evaluated using the Visual Analog Scale (VAS), and functional outcome is assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score. Changes in these outcomes are compared between the two groups during the follow-up period.

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 to 65 years with chronic plantar heel pain who are eligible for ultrasound-guided pulsed radiofrequency (PRF) treatment and have a baseline Visual Analog Scale (VAS) pain score greater than 5. Eligible participants are prospectively enrolled and randomized to receive either PRF of the posterior tibial nerve alone or PRF of both the posterior tibial and sural nerves.

Description

Inclusion Criteria:

Age between 18 and 65 years

Presence of chronic plantar heel pain

Baseline VAS score >5

Exclusion Criteria:

History of foot fracture or tumor

Pregnancy

Coagulopathy or use of antiplatelet therapy

Cognitive impairment preventing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Posterior tibial nerve PRF
Patients with chronic plantar heel pain who received ultrasound-guided pulsed radiofrequency treatment applied only to the posterior tibial nerve as part of routine clinical care.
Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.
Posterior tibial + sural nerve PRF
Patients with chronic plantar heel pain who received ultrasound-guided pulsed radiofrequency treatment applied to both the posterior tibial nerve and the sural nerve as part of routine clinical care.
Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: Baseline, 1 month, and 3 months post-procedure
Visual Analog Scale (VAS) is a simple tool used in clinical trials to measure pain intensity. Patients rate their pain on a scale, typically from 0 (no pain) to 10 (worst imaginable pain). It provides a quick, quantitative assessment of subjective pain and is commonly used to evaluate treatment effectiveness before and after intervention.Change in pain intensity assessed by Visual Analog Scale (VAS)
Baseline, 1 month, and 3 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS
Time Frame: Baseline, 1 month, and 3 months post-procedure
American Orthopaedic Foot and Ankle Society (AOFAS) score is a clinical outcome measure used to assess foot and ankle conditions. It combines pain (40 points), function (50 points), and alignment (10 points) into a total score out of 100. Higher scores indicate better clinical status. It is frequently used in clinical trials to evaluate surgical or conservative treatment outcomes.
Baseline, 1 month, and 3 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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