Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-02 @ 10:49 PM
Study NCT ID:
NCT05920551
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2023-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-17', 'studyFirstSubmitDate': '2023-06-17', 'studyFirstSubmitQcDate': '2023-06-17', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Plantar heel pain intensity', 'timeFrame': 'Changes in Plantar heel pain intensity at Baseline and after 4 weeks of intervention and 3 months', 'description': 'Measured using a Visual Analog Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Changes in Foot mobility', 'timeFrame': 'Changes in foot mobility at Baseline and after 4 weeks of intervention and 3 months', 'description': 'Measured using an inversion/eversion device'}, {'measure': 'Changes in Foot function', 'timeFrame': 'Changes in foot function at Baseline and after 4 weeks of intervention and 3 months', 'description': 'Measured using the Foot and Ankle Ability Measure (FAAM)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plantar Fascitis']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effectiveness of gastrocnemius stretching exercises on plantar heel pain intensity, foot mobility, and function in patients with plantar fasciitis.', 'detailedDescription': 'This randomized controlled trial will include patients diagnosed with plantar fasciitis. Participants will be randomly assigned to either a study group performing gastrocnemius stretches or a control group. Both groups will receive ultrasound therapy and fascia strengthening exercises. The study group will additionally perform specific gastrocnemius stretching exercises. Outcome measures will be assessed before and after 4 weeks of intervention and will include pain intensity, foot mobility using an inversion/eversion device, and function using the Foot and Ankle Ability Measure. The study hypothesizes that the study group will demonstrate greater improvements in pain, foot mobility, and function compared to the control group. The study findings could guide physical therapy interventions for patients with plantar fasciitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pain reproduced with palpation of the plantar fascia\n2. localized and sharp but not radiating\n3. worse in the initial step after and an extended period of rest\n4. decreased initially after the first steps but exacerbated with increased activityat least 6 weeks\n5. unresponsive conservative form of plantar fasciitis care (ie, rest, stretching, full-length silicone insole, prescription NSAIDs when taken for a period of 2 weeks)\n\nExclusion Criteria:\n\n1. history of previous steroid injections\n2. previous surgery of the foot, lumbar spine disc herniation or back injury\n3. patients with rheumatic diseases (e.g., rheumatoid arthritis, spondyloarthropathy, gout disease, enthesopathy, Sjogren's syndrome, and systemic lupus erythematosus)"}, 'identificationModule': {'nctId': 'NCT05920551', 'briefTitle': 'Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Efficacy of Gastrocnemius Stretching on Plantar Heel Pain, Foot Mobility and Function in Patients With Plantar Fasciitis: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '012/7080002023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastrocnemius Stretching Group', 'description': 'Patients will receive ultrasound therapy, fascia strengthening exercises, and gastrocnemius stretching exercises.', 'interventionNames': ['Other: Gastrocnemius Stretching Exercises', 'Other: Standard care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients will receive ultrasound therapy and fascia strengthening exercises without gastrocnemius stretching exercises.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Gastrocnemius Stretching Exercises', 'type': 'OTHER', 'description': 'The gastrocnemius stretching exercises will be performed by patients in the study group. These exercises will involve stretching the gastrocnemius muscle in a controlled manner to improve flexibility and reduce tension in the plantar fascia.', 'armGroupLabels': ['Gastrocnemius Stretching Group']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Ultrasound therapy: A therapeutic ultrasound device will be used to apply ultrasound waves to the plantar fascia area for pain relief and to promote healing. The frequency, intensity, and duration of the ultrasound therapy will be determined by the treating physical therapist based on individual patient needs.Fascia strengthening exercises: Patients will be instructed to perform exercises targeting the intrinsic foot muscles and the plantar fascia to improve strength and function. Examples of these exercises include toe curls, towel scrunches, and arch lifts. Patients will be asked to perform these exercises daily, with the specific number of repetitions and sets determined by the physical therapist.', 'armGroupLabels': ['Control Group', 'Gastrocnemius Stretching Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '01064442032'}], 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'centralContacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '+201064442032'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}