Chronic Plantar Heel PainNCT07383558
Effect of Additional Sural Nerve PRF in Chronic Heel Pain
An observational study of Chronic Plantar Heel Pain and Plantar Fasciitis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Plantar Heel Pain, Plantar Fasciitis, Spur, Heel
- What is being tested?
- Pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age between 18 and 65 years
- Presence of chronic plantar heel pain
- Baseline VAS score >5
Who cannot join
- History of foot fracture or tumor
- Pregnancy
- Coagulopathy or use of antiplatelet therapy
- Cognitive impairment preventing informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ayse Betul Acar
Ankara, 06500
Omer Taylan Akkaya, 05325569847, dr.taylanakkaya@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Plantar Heel Pain, Plantar Fasciitis, Spur, Heel
- Being tested
- Pulsed radiofrequency
- Keywords
- posterior tibial nerve, sural nerve, heel pain, plantar pain
- Medical subject headings
- Fasciitis, Plantar, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequencyProcedure or surgery
Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 1 month, and 3 months post-procedure
Secondary outcomes (1)
AOFAS
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.
Measured: Baseline, 1 month, and 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Plantar Heel PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383558
- Sponsor's protocol ID
- Sural-Posterior Tibial PRF
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26643244Wu 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.
PubMed 28209507Yildiz 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.
PubMed 38652568
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Targeting the Sural Nerve in Addition to the Posterior Tibial Nerve Increase the Effectiveness of Pulsed Radiofrequency Treatment in Chronic Plantar Heel Pain?
- ClinicalTrials.gov ID
- NCT07383558
- Acronym / sponsor ID
- Sural-Posterior Tibial PRF
- Conditions
- Chronic Plantar Heel Pain, Plantar Fasciitis, Spur, Heel
- Keywords
- posterior tibial nerve, sural nerve, heel pain, plantar pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior tibial nerve PRF | – | Procedure: Pulsed radiofrequencyPatients 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. |
| Posterior tibial + sural nerve PRF | – | Procedure: Pulsed radiofrequencyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Presence of chronic plantar heel pain
- Baseline VAS score >5
Key exclusion criteria (4 listed)
- History of foot fracture or tumor
- Pregnancy
- Coagulopathy or use of antiplatelet therapy
- Cognitive impairment preventing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed radiofrequencyUltrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve. | Procedure or surgery | Posterior tibial + sural nerve PRF, Posterior tibial nerve PRF |
Primary outcome
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)
1 secondary outcome
AOFAS
Time frame: Baseline, 1 month, and 3 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 26643244Agyekum EK, Ma K. Heel pain: A systematic review. Chin J Traumatol. 2015;18(3):164-9. doi: 10.1016/j.cjtee.2015.03.002.
- Background: PubMed 28209507Wu 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.
- Background: PubMed 38652568Yildiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Plantar Heel Pain and Plantar Fasciitis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: Baseline, 1 month, and 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07383558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.