Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:33 PM
Study NCT ID:
NCT07462169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Laser VS High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of change of pain intensity', 'timeFrame': 'At baseline and after 4 weeks of intervention', 'description': 'The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice. Studies have shown moderate to strong correlations for VAS validity in pain measurement.'}], 'secondaryOutcomes': [{'measure': 'Assessment of change of pressure pain threshold', 'timeFrame': 'At baseline and after 4 weeks of intervention', 'description': 'A pressure algometer is a reliable tool for determining local pressure pain threshold (PPT) in different pain syndromes. It is a force gauge calibrated in kg/cm2 and has a range of 0-10 kg/cm2. A manual pressure algometer will be used to measure pain threshold for heel, with repeated measurements to improve reliability.'}, {'measure': 'Assessment of change of Ankle Range of motion', 'timeFrame': 'At baseline and after 4 weeks of Intervention', 'description': 'Electronic goniometer will be used to differentiate changes in ROM. Electronic goniometer was used to evaluated ankle ROM in dorsiflexion and plantar flexion.'}, {'measure': 'Assessment of foot pain and Functional Disability', 'timeFrame': 'At baseline and after 4 weeks of Intervention', 'description': 'The Foot Function Index (FFI) is a validated questionnaire used to evaluate foot pain and functional disability. It includes 23 items assessing pain, disability, and activity limitation. Each item is rated on a scale from 0 to 10, with higher scores indicating greater pain and functional limitation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High power pain Threshold Ultrasound', 'High Intensity Laser therapy', 'plantar fasciitis (PF)', 'HILT'], 'conditions': ['Plantar Fasciitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to\n\n1. Investigate the Effect of High-intensity laser therapy versus High power pain threshold ultrasound on pain level in patients with plantar fasciitis.\n2. Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound on ROM in patients with plantar fasciitis.', 'detailedDescription': "Plantar fasciitis (PF) is one of the most prevalent musculoskeletal disorders of the foot, affecting individuals across different age groups and activity levels. It is clinically characterized by localized pain at the medial aspect of the heel, typically exacerbated during weight-bearing activities, with marked intensity upon the first steps in the morning or following periods of prolonged rest or non-weight bearing. Persistent symptoms may significantly impair functional mobility and quality of life.\n\nAmong contemporary conservative management strategies, laser therapy has emerged as a promising non-invasive modality for PF treatment. Recently, High-Intensity Laser Therapy (HILT) has been introduced as an advanced therapeutic option. Due to its high peak power and deeper tissue penetration capability, HILT can effectively stimulate large and deep fascial structures, potentially enhancing tissue repair, modulating inflammation, and reducing pain perception.\n\nHigh-Power Pain Threshold Ultrasound (HPPTUS) represents a modified therapeutic ultrasound technique that delivers energy at intensities approaching the patient's pain threshold. This approach aims to maximize deep tissue stimulation while maintaining patient tolerance. HPPTUS has demonstrated superior clinical outcomes compared to conventional ultrasound techniques, particularly in the management of myofascial pain syndrome, with significant reductions in pain intensity and improvements in range of motion (ROM) achieved within fewer treatment sessions.\n\nThe study aims to Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound in the treatment of plantar fasciitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient age ranged from 30 to 60 years.\n2. Plantar heel pain lasting for at least one month, mainly during the first few steps upon rising in the morning, which worsens with increased weight-bearing activity through the day.\n3. Tenderness at the insertion site of the plantar fascia on the calcaneus.\n4. Body mass index (MBI) \\<30 kg/m2\n\nExclusion Criteria:\n\n1. Medical red flag history (such as tumor, fracture, heterotrophic ossification, and acute inflammatory disease in the ankle-foot area.\n2. If the patient has history of recent trauma or foot surgery.\n3. Wounds, infections in the treatment area.\n4. Subjects with referred pain from sciatica and other neurological disorders.\n5. History of corticosteroid injection in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT07462169', 'acronym': 'HILT - HPPTUS', 'briefTitle': 'High Intensity Laser VS High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'High Intensity Laser Versus High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis', 'orgStudyIdInfo': {'id': 'P.T.REC/012/006276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 → High intensity laser therapy', 'description': 'High Intensity Laser therapy this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month', 'interventionNames': ['Device: High intensity laser therapy', 'Other: Conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 → High power pain threshold ultrasound', 'description': 'High power pain threshold ultrasound this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month', 'interventionNames': ['Device: High power pain threshold ultrasound', 'Other: Conventional treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3 → Conventional treatment', 'description': 'conventional treatment this group consists of 20 subjects will receive conventional treatment only, three times per week for one month\n\nInterventions:\n\nConventional treatment', 'interventionNames': ['Other: Conventional treatment']}], 'interventions': [{'name': 'High intensity laser therapy', 'type': 'DEVICE', 'description': 'This group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month', 'armGroupLabels': ['Arm 1 → High intensity laser therapy']}, {'name': 'High power pain threshold ultrasound', 'type': 'DEVICE', 'description': 'this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month', 'armGroupLabels': ['Arm 2 → High power pain threshold ultrasound']}, {'name': 'Conventional treatment', 'type': 'OTHER', 'description': 'this group consists of 20 subjects will receive conventional treatment only, three times per week for one month', 'armGroupLabels': ['Arm 1 → High intensity laser therapy', 'Arm 2 → High power pain threshold ultrasound', 'Arm 3 → Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'country': 'Egypt', 'contacts': [{'name': 'Sara K Ghoneem, MD', 'role': 'CONTACT', 'email': 'sara.khaled.pt@o6u.edu.eg', 'phone': '+201014883465'}, {'name': 'Doaa R Elazab, PHD', 'role': 'CONTACT', 'email': 'doaa.rafat@pt.cu.edu.eg', 'phone': '+201005591580'}], 'facility': 'Outpatient clinic of Faculty of Physical Therapy Benha National University.', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator', 'investigatorFullName': 'Sarah Khaled Attia Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}