Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT03231566
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome measures were mailed by patients in prepaid envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Change from Baseline to 1 month, 3 months and 6 months post-surgery', 'description': 'Numeric Pain Rating Scale'}, {'measure': 'Function', 'timeFrame': 'Change from Baseline to 1 month, 3 months and 6 months post-surgery', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': 'Pain Catastrophization', 'timeFrame': 'Change from Baseline to 1 month, 3 months and 6 months post-surgery', 'description': 'Pain Catastrophization Scale'}, {'measure': 'Fear of movement', 'timeFrame': 'Change from Baseline to 1 month, 3 months and 6 months post-surgery', 'description': 'Tampa Scale of Kinesiophobia'}], 'secondaryOutcomes': [{'measure': 'Opioid Use', 'timeFrame': 'Change at 1 month', 'description': 'Oral Morphine Dose Equivalents'}, {'measure': 'Healthcare Expenses', 'timeFrame': 'Change from Baseline to 1 month, 3 months and 6 months post-surgery', 'description': 'Costs associated with healthcare utilization'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Change at 1 month, 3 months and 6 months post-surgery', 'description': 'Likert questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery', 'detailedDescription': 'To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA\n\nExclusion Criteria:\n\n* Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.'}, 'identificationModule': {'nctId': 'NCT03231566', 'briefTitle': 'Pain Neuroscience Education in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '710848-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual education control group (CG)', 'description': 'The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information.', 'interventionNames': ['Behavioral: Pain Neuroscience Education']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group (EG)', 'description': 'The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA.', 'interventionNames': ['Behavioral: Pain Neuroscience Education']}], 'interventions': [{'name': 'Pain Neuroscience Education', 'type': 'BEHAVIORAL', 'description': 'See arm/group description', 'armGroupLabels': ['Experimental group (EG)', 'Usual education control group (CG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89154', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada Las Vegas - Department of Physical Therapy', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Emilio J Puentedura, PT, DPT, PhD', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}