NCT07383558

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jun 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2025Sep 2026

Study Start

First participant enrolled

June 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 26, 2026

Last Update Submit

February 23, 2026

Conditions

Chronic Plantar Heel PainPlantar FasciitisSpur, Heel

Keywords

posterior tibial nerve, sural nerve, heel pain, plantar pain

Outcome Measures

Primary Outcomes (1)

  • VAS

    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 Outcomes (1)

  • AOFAS

    Baseline, 1 month, and 3 months post-procedure

Study Arms (2)

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.

Procedure: Pulsed radiofrequency

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.

Procedure: Pulsed radiofrequency

Interventions

Pulsed radiofrequencyPROCEDURE

Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.

Posterior tibial + sural nerve PRFPosterior tibial nerve PRF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 to 65 years with chronic plantar heel pain who underwent ultrasound-guided pulsed radiofrequency (PRF) treatment of the posterior tibial nerve, with or without additional PRF of the sural nerve, as part of routine clinical care in the Algology Clinic. Patients were included if they had a baseline Visual Analog Scale (VAS) pain score greater than 5. All treatments were completed prior to study enrollment, and no changes were made to clinical management for research purposes.

You may qualify if:

  • Age between 18 and 65 years
  • Presence of chronic plantar heel pain
  • Baseline VAS score \>5

You may not qualify if:

  • History of foot fracture or tumor
  • Pregnancy
  • Coagulopathy or use of antiplatelet therapy
  • Cognitive impairment preventing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayse Betul Acar

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Agyekum EK, Ma K. Heel pain: A systematic review. Chin J Traumatol. 2015;18(3):164-9. doi: 10.1016/j.cjtee.2015.03.002.

    PMID: 26643244BACKGROUND

  • Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14.

    PMID: 28209507BACKGROUND

  • Yildiz G, Perdecioglu GRG, Yuruk D, Can E, Akkaya OT. Comparison of tibial nerve pulsed radiofrequency and intralesional radiofrequency thermocoagulation in the treatment of painful calcaneal spur and plantar fasciitis: a randomized clinical trial. Pain Med. 2024 Aug 1;25(8):493-499. doi: 10.1093/pm/pnae029.

    PMID: 38652568BACKGROUND

MeSH Terms

Conditions

Fasciitis, PlantarHeel Spur

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesExostosesHyperostosisBone Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor Investigator

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

June 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)