Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-13 @ 10:05 PM
Study NCT ID:
NCT06516393
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinesio Tape Application in the Treatment of Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the patients were divided into subgroups by the sports physician according to age, height, body weight and body mass index. Patients with similar characteristics were randomized to one of two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pain on the Visual Analog Scale (VAS) at week 5', 'timeFrame': 'Baseline and week 5', 'description': 'VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10).'}, {'measure': 'Change from baseline Foot function via the Foot Function Index (FFI) at week 5', 'timeFrame': 'Baseline and week 5', 'description': 'FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported'}, {'measure': 'Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5', 'timeFrame': 'Baseline and week 5', 'description': 'The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plantar Fasciitis', 'Radial Extracorporeal Shock Wave Therapy', 'Kinesio Taping', 'Pain'], 'conditions': ['Plantar Fascitis']}, 'referencesModule': {'references': [{'pmid': '40323967', 'type': 'DERIVED', 'citation': 'Kocahan T, Orscelik A, Gunaydin H, Buyukluoglu G, Karaaslan B, Asar E, Akinoglu B. Can kinesio tape negatively affect the treatment by creating a hard floor in plantar fasciitis treatment? A randomized clinical trial. PLoS One. 2025 May 5;20(5):e0322397. doi: 10.1371/journal.pone.0322397. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.', 'detailedDescription': "The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of unilateral plantar fasciitis,\n* The presence of a heel spur on a lateral radiograph\n\nExclusion Criteria:\n\n* Lower extremity surgeries or traumas,\n* Systemic inflammatory disease,\n* Steroid injections administered within the past six months,\n* Pacemaker usage,\n* Coagulation disorders,\n* Use of anticoagulants.'}, 'identificationModule': {'nctId': 'NCT06516393', 'briefTitle': 'Kinesio Tape Application in the Treatment of Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Can Kinesio Tape Negatively Affect the Treatment by Creating a Hard Floor in Plantar Fasciitis Treatment: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GEAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radial extracorporeal shock wave therapy (r-ESWT) application group', 'description': 'Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.', 'interventionNames': ['Device: The radial shock wave device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'r-ESWT + Kinesio taping (KT) application group', 'description': 'Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.', 'interventionNames': ['Device: The radial shock wave device']}], 'interventions': [{'name': 'The radial shock wave device', 'type': 'DEVICE', 'otherNames': ['The r-ESWT+Kinesio taping (KT)'], 'description': 'The r-ESWT+Kinesio Tape Application', 'armGroupLabels': ['Radial extracorporeal shock wave therapy (r-ESWT) application group', 'r-ESWT + Kinesio taping (KT) application group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Bihter Akınoğlu', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Once the study is published, data will be shared.', 'ipdSharing': 'YES', 'description': 'All collected IPD will be shared', 'accessCriteria': 'If ethics committee requirements are met in similar studies to be conducted by clinical researchers, data can be shared with the permission of the clinical officer.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bihter Aslanyurek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Bihter Aslanyurek', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}