Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 11:39 PM
Study NCT ID:
NCT06888804
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Tibial Nerve PRF for Painful Calcaneal Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Change from baseline to 3rd month after treatment', 'description': 'VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)'}], 'secondaryOutcomes': [{'measure': 'The American Orthopaedic Foot and Ankle Society (AOFAS)', 'timeFrame': 'Change from baseline to 3rd month after treatment', 'description': 'The American Orthopaedic Foot and Ankle Society (AOFAS) score is evaluated under three subcategories: pain, function, and alignment. It includes both objective (function and alignment) and subjective (pain) data. Patients report their pain levels, which are then scored by physicians. Additionally, patients and doctors collaborate to complete the functional and alignment assessments.\n\nScores range from 0 to 100, with 100 representing a healthy patient. This scoring system will be assessed pre-procedure, on the day of the procedure, and at the 3-month follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulsed Radiofrequency Treatment', 'Tibial Nerve'], 'conditions': ['Calcaneus Fracture']}, 'descriptionModule': {'briefSummary': 'Patients who underwent pulsed radiofrequency (PRF) treatment of the posterior tibial nerve under ultrasound guidance, which is routinely performed in our clinic for severe heel pain following a calcaneal fracture, were evaluated through interviews. The assessment was conducted using the Visual Analog Scale (VAS) for pain and the American Orthopaedic Foot and Ankle Society (AOFAS) score.', 'detailedDescription': "Pain following a calcaneal fracture can arise from direct injury, traction injury, idiopathic mechanisms such as reflex sympathetic dystrophy/complex regional pain syndrome (CRPS), or nerve damage. Since there is no single standardized definition or diagnosis for post-surgical nerve pain, such cases are described in the literature as neurapraxia, postoperative neuroma, unexplained heel pain, hypersensitive scar, or CRPS. Typically, this type of pain manifests as burning, paresthesia, dysesthesia, and hyperesthesia.\n\nThe tibial nerve plays a crucial role in the sensory and motor innervation of the heel. Following a calcaneal fracture, direct nerve injury, compression, or inflammation of the surrounding tissues may contribute to pain. Pulsed radiofrequency (PRF) has been shown to alleviate chronic pain by delivering an electrical field to the nerve tissue at a controlled temperature of \\<42°C without causing nerve damage. Additionally, there is evidence supporting PRF's effectiveness in pain relief for patients with various chronic conditions.\n\nIn our study, the investigators aim to evaluate patients with persistent pain after a calcaneal fracture who have undergone PRF treatment of the posterior tibial nerve. By monitoring these patients immediately after the intervention, we will assess changes in their pain scores. Additionally, the investigators will compare them to patients with post-calcaneal fracture pain who have opted not to undergo the procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of calcaneal fracture\n* VAS score \\>5\n* Pain persisting for more than 3 months after the fracture\n\nExclusion Criteria:\n\n* Presence of other foot pain-causing conditions (e.g., plantar fasciitis, heel spur)\n* Additional fractures other than the calcaneus\n* Pregnancy\n* Coagulopathy or use of antiplatelet medications\n* Mental illness impairing decision-making ability'}, 'identificationModule': {'nctId': 'NCT06888804', 'briefTitle': 'Posterior Tibial Nerve PRF for Painful Calcaneal Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Evaluation of the Effectiveness of Pulsed Radiofrequency Treatment of the Posterior Tibial Nerve in the Management of Chronic Plantar Pain Due to Calcaneal Fracture', 'orgStudyIdInfo': {'id': 'PTN-RF for calcaneal fracture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Posterior Tibial Nerve PRF for Painful Calcaneal Fracture', 'description': 'posterior tibial nerve pulsed radiofrequency for painful calcaneal fracture', 'interventionNames': ['Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequency']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'control group for painful calcaneal fracture', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'ultrasound-guided posterior tibial nerve pulsed radiofrequency', 'type': 'PROCEDURE', 'description': 'The posterior tibial nerve (PTN) was identified with a 5-12 MHz linear ultrasonography (US) probe at the level of the medial malleolus, where it runs posterior to the posterior tibial artery. Using the in-plane technique, a 22-gauge, 10-cm radiofrequency cannula was inserted under US guidance and advanced until the tip was adjacent to the nerve. Pulse radiofrequency was applied at 42°C for 240 s with a pulse width of 20 ms.', 'armGroupLabels': ['Posterior Tibial Nerve PRF for Painful Calcaneal Fracture']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gevher Rabia Genç Perdecioğlu', 'role': 'CONTACT', 'email': 'gevhergenc@gmail.com', 'phone': '5332009184', 'phoneExt': 'TR'}], 'facility': 'Diskapi Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gokhan Yildiz', 'role': 'CONTACT', 'email': 'gkoyldz@gmail.com', 'phone': '5059272589'}], 'overallOfficials': [{'name': 'Gevher Rabia Genc Perdecioğlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Diskapi TRH'}]}, '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'}}}}