Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-11 @ 12:59 PM
Study NCT ID:
NCT07057505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Fascia Thickness After Steroid Injection in Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plantar fascia thickness', 'timeFrame': 'The thickness measurement will be evaluated immediately after the injection and 1 month after the injection.', 'description': 'Plantar fascia thickness measured by ultrasound'}, {'measure': 'Pain score', 'timeFrame': 'Pain will be assessed with a visual analog scale immediately after injection and 1 month later', 'description': 'Pain score assessed with a visual analog scale between 0 and 100'}], 'secondaryOutcomes': [{'measure': 'Foot functions', 'timeFrame': 'Foot functions will be assessed immediately after injection and 1 month after injection with the foot function index.', 'description': 'Foot functions will be assessed immediately after injection and 1 month after injection with the foot function index.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plantar fasciitis', 'plantar fascia thickness', 'ultrasonographic evaluation', 'injection'], 'conditions': ['Plantar Fasciitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "''Yalıman A, Şen Eİ, Eskiyurt N, Budiman-Mak E. Ayak Fonksiyon İndeksi'nin Plantar Fasiitli Hastalarda Türkçe'ye Çeviri ve Adaptasyonu. Türk Fiz Tıp Rehab Derg 2014;60:212-22''"}, {'pmid': '32817771', 'type': 'BACKGROUND', 'citation': 'Aggarwal P, Jirankali V, Garg SK. Evaluation of plantar fascia using high-resolution ultrasonography in clinically diagnosed cases of plantar fasciitis. Pol J Radiol. 2020 Jul 24;85:e375-e380. doi: 10.5114/pjr.2020.97955. eCollection 2020.'}, {'pmid': '22619193', 'type': 'BACKGROUND', 'citation': 'McMillan AM, Landorf KB, Gilheany MF, Bird AR, Morrow AD, Menz HB. Ultrasound guided corticosteroid injection for plantar fasciitis: randomised controlled trial. BMJ. 2012 May 22;344:e3260. doi: 10.1136/bmj.e3260.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of local corticosteroid injection on pain, foot function index, and plantar fascia thickness in patients clinically diagnosed with plantar fasciitis, and to determine whether local corticosteroid injection is an appropriate treatment option for plantar fasciitis. For this purpose, the study plans to assess plantar fascia thickness using ultrasonography, evaluate pain using the Visual Analog Scale (VAS), and investigate the impact on daily living activities in patients who have been clinically diagnosed with plantar fasciitis and treated with local corticosteroid injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '33 patients who volunteered to participate in the study and applied to the Physical Medicine and Rehabilitation Clinic of the SBÜ Istanbul Physical Therapy and Rehabilitation Education and Research Hospital and were diagnosed with plantar fasciitis clinically and received local corticosteroid injections will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were clinically diagnosed with plantar fasciitis and received corticosteroid injections\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients who have had more than one corticosteroid injection in the last 6 months\n* Patients with systemic inflammatory diseases\n* Patients who have previously undergone surgery in the heel area\n* Patients with a history of local trauma'}, 'identificationModule': {'nctId': 'NCT07057505', 'briefTitle': 'Pain and Fascia Thickness After Steroid Injection in Plantar Fasciitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Assesment of Pain, Foot Function, and Ultrasonographic Evaluation of Plantar Fascia Thickness in Patients Treated With Local Corticosteroid Injection for Plantar Fasciitis', 'orgStudyIdInfo': {'id': '2025-41'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plantar Fasciitis Patients with Corticosteroid Injection', 'description': 'The study cohort consists of patients clinically diagnosed with plantar fasciitis who have received local corticosteroid injections as part of their treatment. These patients were selected based on clinical criteria for plantar fasciitis and have undergone at least one ultrasound-guided corticosteroid injection targeting the affected plantar fascia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34188', 'city': 'Istanbul', 'state': 'Bahçelievler', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Tekne, MD', 'role': 'CONTACT', 'email': 'mehmettekne23@gmail.com', 'phone': '+90 541 547 33 23'}], 'facility': 'Istanbul physical therapy rehabilitation training and research hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mehmet Tekne, Resident Doctor', 'role': 'CONTACT', 'email': 'mehmettekne23@gmail.com', 'phone': '+905415473323'}], 'overallOfficials': [{'name': 'Mehmet Tekne, Resident Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul physical therapy rehabilitation training and research hospital'}, {'name': 'Nurdan Paker, Professor Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul physical therapy rehabilitation training and research hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'mehmet tekne', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}