Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06335602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TCM for Post-operative Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg girth measurement', 'timeFrame': 'before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation', 'description': 'lower limb multiple girth measurement'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation', 'description': 'general scoring of pain'}, {'measure': 'WOMAC', 'timeFrame': 'before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation', 'description': 'specific scoring of joint pain'}, {'measure': 'Tegner score', 'timeFrame': 'before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation', 'description': 'scoring of joint activity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': "There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.\n\nCruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to sign informed consent\n2. Age between 18-50 years old male and female patients\n3. First time receiving cruciate ligament reconstruction\n4. Willing to accept TCM intervention and follow up\n\nExclusion Criteria:\n\n1. Repeat surgical intervention\n2. History of serious acupuncture syncope\n3. History of severe allergic response of herbal packing or drug-induced dermatitis\n4. History of other diseases that cause knee joint swelling, such as rheumatoid arthritis, knee joint infection, gouty arthritis, connective tissue disease, tumor, or cardiac/renal failure.'}, 'identificationModule': {'nctId': 'NCT06335602', 'briefTitle': 'TCM for Post-operative Edema', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Evaluation of Traditional Chinese Medicine Intervention for Post-operative Edema After Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '202301283A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Acupuncture Treat', 'description': 'Low level laser therapy to acupoints related to operation wound, before and after operation', 'interventionNames': ['Device: LASER acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Laser Acupuncture Sham', 'description': 'Low level laser therapy(with Sham device) to acupoints related to operation wound, before and after operation', 'interventionNames': ['Device: LASER acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Herbal packing', 'description': 'External application of herbal medicine packing around the operation wound, before and after operation', 'interventionNames': ['Device: LASER acupuncture']}], 'interventions': [{'name': 'LASER acupuncture', 'type': 'DEVICE', 'description': 'Low level LASER therapy', 'armGroupLabels': ['Herbal packing', 'Laser Acupuncture Sham', 'Laser Acupuncture Treat']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'YI-WEN HSIEH', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}