Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 11:42 AM
Study NCT ID:
NCT05915650
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale pain score, (VAS)', 'timeFrame': '3 months after discharge', 'description': 'Status of pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study intends to carry out pain neuroscience education intervention for TKA patients to clarify the effect of this method on the degree of postoperative pain, the incidence of pain catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as to provide a basis for clinical nursing of such patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time;\n2. The subjects included in this study were men or women aged 45-74 years;\n3. Clear self-cognition, can browse the text by themselves or can answer questions correctly;\n4. Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study;\n5. Without serious physical diseases such as heart, liver or kidney;\n6. No history of mental illness or drug dependence.\n\nExclusion Criteria:\n\n1. Combined with severe trauma in other parts;\n2. Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases;\n3. Patients with knee tumor and severe knee deformity who could not complete the rehabilitation;\n4. With neurological diseases that limit physical activity;\n5. Participating in other investigators during the same period.'}, 'identificationModule': {'nctId': 'NCT05915650', 'briefTitle': 'Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Zunyi Medical College'}, 'officialTitle': 'Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'KLLY-2020-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Neuroscience Education Group', 'interventionNames': ['Behavioral: Pain Neuroscience Education']}, {'type': 'EXPERIMENTAL', 'label': 'Routine Education Group', 'interventionNames': ['Behavioral: Routine Education']}], 'interventions': [{'name': 'Pain Neuroscience Education', 'type': 'BEHAVIORAL', 'description': 'Carry out pain neuroscience education intervention for TKA patients', 'armGroupLabels': ['Pain Neuroscience Education Group']}, {'name': 'Routine Education', 'type': 'BEHAVIORAL', 'description': 'Carry out routine education intervention for TKA patients', 'armGroupLabels': ['Routine Education Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'Yongmei Zhang', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zunyi Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Yongmei Zhang', 'investigatorAffiliation': 'Zunyi Medical College'}}}}