Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:31 PM
Study NCT ID:
NCT07463794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Extracorporeal Shock Wave Therapy and Whole Body Vibration Therapy in Plantar Fasciitis
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': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors were blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to one of two parallel groups to receive either extracorporeal shock wave therapy or whole body vibration therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot Function Index (FFI)', 'timeFrame': 'Baseline, 5 weeks and 9 weeks', 'description': 'Foot Function Index (FFI), a self-reported questionnaire consisting of 23 items in three subscales (pain, disability, and activity limitation), with scores ranging from 0 to 100. Higher scores indicate worse foot-related disability.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 5 weeks and 9 weeks', 'description': 'Pain severity assessed using the Visual Analog Scale (VAS).Visual Analog Scale (VAS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.'}, {'measure': 'American Orthopaedic Foot and Ankle Society Score (AOFAS)', 'timeFrame': 'Baseline, 5 weeks and 9 weeks', 'description': 'American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score, ranging from 0 to 100, where higher scores indicate better function.'}, {'measure': 'Roles and Maudsley Score', 'timeFrame': 'Baseline, 5 weeks and 9 weeks', 'description': 'Clinical outcome assessed using the Roles and Maudsley score.Roles and Maudsley Score (RM score), a 4-point ordinal scale ranging from 1 (excellent) to 4 (poor). Lower scores indicate better clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plantar Fasciitis', 'Extracorporeal Shock Wave Therapy', 'ESWT', 'Whole Body Vibration Therapy', 'Foot Function Index', 'Randomized Controlled Trial'], 'conditions': ['Plantar Fasciitis', 'Calcaneal Spur']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gerdesmeyer L, Frey C, Vester J, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic plantar fasciitis. Journal of Rehabilitation Medicine. 2008;40(6):425-430. doi:10.2340/jrm.v55.12405.'}]}, 'descriptionModule': {'briefSummary': 'Plantar fasciitis is a common cause of heel pain that can lead to functional limitation and decreased quality of life. Various conservative treatment modalities are used in its management. This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and whole body vibration therapy in patients with plantar fasciitis. The study is designed as a randomized, prospective, single-blind clinical trial. Clinical outcomes will be evaluated using pain and functional assessment scales before and after treatment.', 'detailedDescription': 'This randomized, prospective, single-blind clinical trial was conducted to compare the effects of extracorporeal shock wave therapy (ESWT) and whole body vibration therapy in patients diagnosed with plantar fasciitis. A total of 60 patients aged between 18 and 65 years were included in the final analysis. Participants were randomly assigned into two groups.\n\nThe first group received extracorporeal shock wave therapy applied once weekly for a total of five sessions. The second group received whole body vibration therapy three times per week for five weeks. Both groups followed the same standardized home exercise program during the treatment period.\n\nClinical evaluations were performed at baseline, at the end of treatment, and at the ninth week. The primary outcome measure was functional status assessed using the Foot Function Index (FFI). Secondary outcome measures included pain intensity assessed by the Visual Analog Scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) score, and the Roles and Maudsley score.The aim of this study is to determine and compare the clinical effectiveness of ESWT and whole body vibration therapy in the management of plantar fasciitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Clinically diagnosed plantar fasciitis\n* Heel pain lasting at least 4 weeks\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* History of inflammatory rheumatic diseases\n* Previous foot or ankle surgery\n* Major trauma to the foot or ankle\n* Neurological or vascular disorders of the lower extremities\n* Pregnancy or lactation\n* Corticosteroid injection to the foot within the last 3 months\n* Physical therapy, extracorporeal shock wave therapy, or whole body vibration therapy within the last 3 months'}, 'identificationModule': {'nctId': 'NCT07463794', 'briefTitle': 'Comparison of Extracorporeal Shock Wave Therapy and Whole Body Vibration Therapy in Plantar Fasciitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Plantar Fasiit Tedavisinde ESWT ve Tüm Vücut Vibrasyon Uygulamalarının Etkinliğinin Karşılaştırılması: Randomize, Prospektif, Tek Kör Çalışma', 'orgStudyIdInfo': {'id': 'IMU-EC-945-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracorporeal Shock Wave Therapy (ESWT)', 'description': 'Participants received extracorporeal shock wave therapy once weekly for five sessions.', 'interventionNames': ['Device: Extracorporeal Shock Wave Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Whole Body Vibration Therapy', 'description': 'Participants received whole body vibration therapy three times per week for five weeks.', 'interventionNames': ['Device: Whole Body Vibration Therapy']}], 'interventions': [{'name': 'Extracorporeal Shock Wave Therapy', 'type': 'DEVICE', 'description': 'Extracorporeal shock wave therapy was applied once weekly for a total of five sessions to the affected heel.', 'armGroupLabels': ['Extracorporeal Shock Wave Therapy (ESWT)']}, {'name': 'Whole Body Vibration Therapy', 'type': 'DEVICE', 'description': 'Whole body vibration therapy was applied three times per week for five weeks using a vibration platform.', 'armGroupLabels': ['Whole Body Vibration Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34245', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpaşa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Berrin Hüner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpaşa Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the study is a single-center academic thesis study, and the data contain personal and sensitive health information. There is no separate data-sharing agreement or repository planned for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}