Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT05357703
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of pain', 'timeFrame': 'one month', 'description': 'Change from baseline in pain score by VAS'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in WOMAC score [ time point - 1 month]', 'timeFrame': 'one month', 'description': 'The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness. It widely used in clinical studies as primary or secondary outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photobiomodulation', 'Low-Level Laser Therapy'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if B-Cure laser treatments, applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.', 'detailedDescription': 'Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.\n\nThe study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)\n2. Kellgren \\& Lawrence classification 2-3\n3. Knee pain on movement 40 to 90 mm Visual Analog Scale\n4. Knee pain and related functional reduction for the last ≥ 3 months\n5. Agrees not to use NSAIDs throughout the experiment\n\nExclusion Criteria:\n\n1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control\n2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.\n3. Knee surgery for KOA\n4. Intra-articular steroid injection and/or oral steroid treatment within the last six months\n5. Rheumatoid arthritis\n6. Active malignancy\n7. Uncontrolled diabetes mellitus\n8. Neurological conditions: sciatica, neuropathy, multiple sclerosis\n9. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain\n10. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain\n11. Has known dermatological sensitivity to light\n12. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT05357703', 'acronym': 'PBM&KOA-02', 'briefTitle': 'Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Erika Carmel ltd'}, 'officialTitle': 'Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: An Open Label, Single-Arm Clinical Trial', 'orgStudyIdInfo': {'id': 'HFH-256-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard treatment + Active B-Cure laser', 'description': 'Subjects from Standard treatment + Active B-Cure laser will receive standard care and in addition will self-treat at home with the B-Cure device.', 'interventionNames': ['Device: Standard treatment + Active B-Cure laser']}], 'interventions': [{'name': 'Standard treatment + Active B-Cure laser', 'type': 'DEVICE', 'description': 'The B-Cure laser pro is a portal, non-invasive, photobiomodulation device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/minute.', 'armGroupLabels': ['Standard treatment + Active B-Cure laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nazareth', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jehad Khazen, MD', 'role': 'CONTACT', 'email': 'khazenjehad@gmail.com', 'phone': '972545600095'}, {'name': 'Maroun Yacoub', 'role': 'CONTACT', 'email': 'maroun@gd-energies.com', 'phone': '+9720543349738', 'phoneExt': '+9720543349738'}], 'facility': 'Holy Family Hospital', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}], 'centralContacts': [{'name': 'Jehad Khazen, MD', 'role': 'CONTACT', 'email': 'khazenjehad@gmail.com', 'phone': '+972545600095'}], 'overallOfficials': [{'name': 'Marwan Hadad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Holy Family Hospital, Nazareth, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erika Carmel ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holy Family Hospital, Nazareth, Israel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}