Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
Study NCT ID:
NCT04628312
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Foot Plantar Pressure Changes After Plantar Dry Needling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D005534', 'term': 'Foot Diseases'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-11-07', 'studyFirstSubmitQcDate': '2020-11-07', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variables of plantar pressures with platform before dry puncture', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'During 30 seconds we will record the plantar pressure variables in grams per square centimeter.'}, {'measure': 'Variable footprint plantar surface with platform before dry puncture', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'For 30 seconds we will record the area of the footprint in square centimeters.'}, {'measure': 'Variables of plantar pressures with platform after dry puncture', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'During 30 seconds we will record the plantar pressure variables in grams per square centimeter.'}, {'measure': 'Variable footprint plantar surface with platform after dry puncture', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'For 30 seconds we will record the area of the footprint in square centimeters.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myofascial Pain Syndrome', 'Foot Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to check the effects of dry needling in the Flexor digitorum Brevis.\n\nTwenty healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure static footprint variables. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Flat foot grade II or II with\n* Must have latent trigger point in Flexor Brevis Digitorum muscles\n\nExclusion Criteria:\n\n* Previous lower extremities surgery.\n* History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.\n* Leg-length discrepancy more than 1 cm'}, 'identificationModule': {'nctId': 'NCT04628312', 'briefTitle': 'Foot Plantar Pressure Changes After Plantar Dry Needling', 'organization': {'class': 'OTHER', 'fullName': 'Mayuben Private Clinic'}, 'officialTitle': 'Standing Plantar Pressure Changes After Plantar Dry Needling in Flexor Digitorum Brevis', 'orgStudyIdInfo': {'id': '2706201911419 C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point', 'description': 'Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point', 'interventionNames': ['Other: Static footprint']}], 'interventions': [{'name': 'Static footprint', 'type': 'OTHER', 'description': 'The static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned 30 degrees from the midline.', 'armGroupLabels': ['Bilateral dry needling in Flexor Brevis Digitorum in subjects with latent trigger point']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28702', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Mayuben Clinic', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayuben Private Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Podiatry, Principal Investigator, and Physiotherapist', 'investigatorFullName': 'EVA MARIA MARTÍNEZ JIMENEZ', 'investigatorAffiliation': 'Mayuben Private Clinic'}}}}