Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT06426251
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of bioimpedance', 'timeFrame': 'the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks', 'description': 'bioimpedance of the surgical site will be measured for evaluation of swelling change'}], 'secondaryOutcomes': [{'measure': 'pain score (visual analogue score)', 'timeFrame': 'once daily since post operative day1 to day6', 'description': 'patient reported pain score, from 0 to 100 points'}, {'measure': 'active range of motion of knee', 'timeFrame': 'once daily since post operative day1 to day6', 'description': 'active range of motion of knee'}, {'measure': '2 minute walk test', 'timeFrame': 'once daily since post operative day1 to day6', 'description': 'the distance that the patient could walk within 2 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Osteoarthritis', 'Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '34800495', 'type': 'BACKGROUND', 'citation': 'de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17.'}, {'pmid': '32186975', 'type': 'BACKGROUND', 'citation': 'Vassao PG, Renno AC, Smith BN, Bennett GB, Murphy M, Liebert A, Chow R, Laakso EL. Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 Study. Photobiomodul Photomed Laser Surg. 2020 Apr;38(4):206-214. doi: 10.1089/photob.2019.4751. Epub 2020 Mar 18.'}, {'pmid': '39786308', 'type': 'DERIVED', 'citation': 'Chia WT, Wong TH, Jaw FS, Hsieh HC. The Impact of Photobiomodulation Therapy on Swelling Reduction and Recovery Enhancement in Total Knee Arthroplasty: A Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2025 Feb;43(2):65-72. doi: 10.1089/photob.2024.0120. Epub 2025 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Photobiomdoulation is the use of near-infrared light to relieve pain, stimulate healing and reduce inflammation. Swelling and inflammation is a common condition after orthopedics surgeries over extremity and spine. This study aim to evaluate the effect of photobiomodulation over patients after Total Knee Arthroplasty.', 'detailedDescription': 'Patients aged over 20 after Total Knee Arthroplasty in our institution would be candidate for recruitment. The patients will be randomized to receive routine post operative care or photobiomodulation therapy. The swelling extent and subjective outcome will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* total knee arthroplasty\n\nExclusion Criteria:\n\n* open injury\n* pregnancy\n* wound without primary closure\n* infection\n* previous surgery over surgical site\n* skin defect'}, 'identificationModule': {'nctId': 'NCT06426251', 'briefTitle': 'Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '111-036-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light.', 'interventionNames': ['Device: Photobiomodulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'This group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light.', 'interventionNames': ['Device: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'description': 'Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6', 'armGroupLabels': ['control group', 'intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hsinchu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiang-Chieh Hsieh', 'role': 'CONTACT', 'email': 'thungjay2@gmail.com', 'phone': '+886972654075'}], 'facility': 'National Taiwan University Hospital, Hsin-Chu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}], 'centralContacts': [{'name': 'Hsiang-Chieh Hsieh', 'role': 'CONTACT', 'email': 'thungjay2@gmail.com', 'phone': '886972654075'}], 'overallOfficials': [{'name': 'Hsiang-Chieh Hsieh', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital Hsin-Chu Branch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}