- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383558
Effect of Additional Sural Nerve PRF in Chronic Heel Pain
Does Targeting the Sural Nerve in Addition to the Posterior Tibial Nerve Increase the Effectiveness of Pulsed Radiofrequency Treatment in Chronic Plantar Heel Pain?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic plantar heel pain is a common condition frequently managed with interventional pain procedures. In routine clinical practice, pulsed radiofrequency (PRF) is commonly applied to the posterior tibial nerve under ultrasound guidance. In selected patients, PRF is additionally applied to the sural nerve based on clinical judgment.
This observational study includes patients who have already undergone PRF treatment as part of standard care in the Algology Clinic. Patients will not be randomized, and no modification to treatment plans will be made for study purposes. Patients will be divided into two groups: those who received PRF to the posterior tibial nerve alone, and those who received PRF to both the posterior tibial and sural nerves. Pain intensity and functional outcomes will be retrospectively evaluated and compared between groups.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06500
- Recruiting
- Ayse Betul Acar
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Contact:
- Omer Taylan Akkaya
- Phone Number: 05325569847
- Email: dr.taylanakkaya@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.
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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.
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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)
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Baseline, 1 month, and 3 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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AOFAS
Time Frame: Baseline, 1 month, and 3 months post-procedure
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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.
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Baseline, 1 month, and 3 months post-procedure
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
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
- Sural-Posterior Tibial PRF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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