Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:31 AM
Study NCT ID:
NCT07383558
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Additional Sural Nerve PRF in Chronic Heel Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}, {'id': 'D036982', 'term': 'Heel Spur'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D005096', 'term': 'Exostoses'}, {'id': 'D015576', 'term': 'Hyperostosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061208', 'term': 'Pulsed Radiofrequency Treatment'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'Baseline, 1 month, and 3 months post-procedure', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'AOFAS', 'timeFrame': 'Baseline, 1 month, and 3 months post-procedure', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['posterior tibial nerve, sural nerve, heel pain, plantar pain'], 'conditions': ['Chronic Plantar Heel Pain', 'Plantar Fasciitis', 'Spur, Heel']}, 'referencesModule': {'references': [{'pmid': '26643244', 'type': 'BACKGROUND', 'citation': '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': '28209507', 'type': 'BACKGROUND', 'citation': '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': '38652568', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 18 and 65 years\n\nPresence of chronic plantar heel pain\n\nBaseline VAS score \\>5\n\nExclusion Criteria:\n\nHistory of foot fracture or tumor\n\nPregnancy\n\nCoagulopathy or use of antiplatelet therapy\n\nCognitive impairment preventing informed consent'}, 'identificationModule': {'nctId': 'NCT07383558', 'briefTitle': 'Effect of Additional Sural Nerve PRF in Chronic Heel Pain', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Does Targeting the Sural Nerve in Addition to the Posterior Tibial Nerve Increase the Effectiveness of Pulsed Radiofrequency Treatment in Chronic Plantar Heel Pain?', 'orgStudyIdInfo': {'id': 'Sural-Posterior Tibial PRF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Posterior tibial nerve PRF', 'description': '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.', 'interventionNames': ['Procedure: Pulsed radiofrequency']}, {'label': 'Posterior tibial + sural nerve PRF', 'description': '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.', 'interventionNames': ['Procedure: Pulsed radiofrequency']}], 'interventions': [{'name': 'Pulsed radiofrequency', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided pulsed radiofrequency applied to the posterior tibial nerve, with or without additional application to the sural nerve.', 'armGroupLabels': ['Posterior tibial + sural nerve PRF', 'Posterior tibial nerve PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Omer Taylan Akkaya', 'role': 'CONTACT', 'email': 'dr.taylanakkaya@gmail.com', 'phone': '05325569847'}], 'facility': 'Ayse Betul Acar', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Supervisor Investigator', 'investigatorFullName': 'Damla Yürük', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}