Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-04-08 @ 10:22 AM
Study NCT ID:
NCT06350435
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D037061', 'term': 'Metatarsalgia'}], 'ancestors': [{'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale', 'timeFrame': 'Baseline, a follow-up at 4-8 weeks from baseline', 'description': 'VAS consists of a 100mm-long uninterrupted horizontal line, with 2 verbal description at each end. A score of 0mm represents "no pain" while 100 mm represents "the worst imaginable pain".'}], 'secondaryOutcomes': [{'measure': 'Foot and Ankle Outcome Score (FAOS)', 'timeFrame': 'Baseline, a follow-up at 4-8 weeks from baseline', 'description': 'FAOS consists of 42 questions, which are categorized into 5 subdomains: symptoms, pain, activities of daily living, sports and quality of life. Each question id rated on a 5-point Likert scale, ranging from 0 to 4 and subsequently transformed into a normalized score between 0 and 100. A score of 100 indicates absence of symptoms, while a score of 0 indicates the presence of severe symptoms.'}, {'measure': 'Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints', 'timeFrame': 'Baseline, a follow-up at 4-8 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metatarsalgia']}, 'descriptionModule': {'briefSummary': 'Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.', 'detailedDescription': 'Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);\n* Able to be ambulant\n\nExclusion Criteria:\n\n* Peripheral vascular disease (PVD)\n* Neurological dysfunctions or neuromuscular disorders\n* Active infection, i.e., cellulitis, osteomyelitis, shingles\n* Cognitive impairment\n* History of lower limb surgery and currently undergoing rehabilitation\n* Active ulceration on foot and ankle\n* Current utilization of prescribed insoles'}, 'identificationModule': {'nctId': 'NCT06350435', 'briefTitle': 'Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CUHK 2023.569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Device: Prefabricated foot orthoses (PFO) with metatarsal pads']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Device: Prefabricated foot orthoses (PFO) without metatarsal pads']}], 'interventions': [{'name': 'Prefabricated foot orthoses (PFO) with metatarsal pads', 'type': 'DEVICE', 'otherNames': ['Slimflex® Amber Insoles', 'Podotech® High Density Metatarsal Pad- Wide Raise SD2121, SD2122, SD2123'], 'description': 'A pair of prefabricated foot orthoses, each with a metatarsal pad to be affixed underneath', 'armGroupLabels': ['Experimental Group']}, {'name': 'Prefabricated foot orthoses (PFO) without metatarsal pads', 'type': 'DEVICE', 'otherNames': ['Slimflex® Amber Insoles'], 'description': 'A pair of prefabricated foot orthoses only', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Fung Ting Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pamela Youde Nethersole Eastern Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Chan Fung Ting', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}