Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 3:25 AM
Study NCT ID:
NCT03293212
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and Medical Resource Utilization of Postoperative Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-23', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scale (NRS) of pain', 'timeFrame': 'Within 7 days after 1st visit', 'description': '11-point pain scale'}], 'secondaryOutcomes': [{'measure': 'Five level version of EuroQol-5 Dimension (EQ-5D-5L)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)'}, {'measure': 'Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Oswestry Disability Index (ODI)'}, {'measure': 'Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Neck Disability Index (NDI)'}, {'measure': 'Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)'}, {'measure': 'Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Shoulder Pain and Disability Index (SPADI)'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.'}, {'measure': 'Medical service use', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Type(s) of medical service use before and after surgery post-onset'}, {'measure': 'Medical costs', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Medical costs from medical service use before and after surgery post-onset'}, {'measure': 'Satisfaction with and preference for conventional and Korean medicine', 'timeFrame': 'Within 7 days after 1st visit', 'description': 'Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Failed back surgery syndrome', 'Korean medicine'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess and analyze the characteristics and usage of conventional and Korean medical services in postoperative patients. This study therefore investigates the proportion of patients with a history of surgery out of patients visiting a spine-specialty Korean medicine hospital, and the prognosis and preference for conventional and Korean medicine treatment by previous treatment history in postoperative patients.', 'detailedDescription': 'A considerable number of patients suffer prolonged chronic pain that does not retract or diminish after surgery, and are thus unable to achieve the desired results in receiving surgical treatment. Postoperative pain is gradually being perceived as a social issue as opposed to a personal health condition. Meanwhile, although efforts to address chronic pain with integrative medicine are continued in answer to the lack of success of pain management through surgery, there is still a lack of supporting evidence.\n\nThe objective of this survey study is to assess the characteristics, usage of conventional and Korean medical services, and prognosis by period before and after surgery in postoperative patients visiting a Korean medicine hospital, and analyze the associations between the preference for conventional and Korean medicine treatment. This study therefore investigates the usage of conventional and Korean medical services in postoperative patients, and is expected to provide information that will potentially aid patient decision making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chief complaint(s) of at least one or more of the following: low back pain (or radiating leg pain), neck pain (or radiating arm pain), knee pain, or shoulder pain\n* Patients with a history of musculoskeletal surgery related to the chief complaint(s)\n* Patients capable of effective communication with the researcher(s) and understanding the survey items\n* Patients who have given written informed consent\n\nExclusion Criteria:\n\n* Patients without a history of musculoskeletal surgery associated with the low back, neck, shoulder, or knee region(s)\n* Patients whose current pain is mainly attributed to traffic accident injury\n* Patients incapable of answering the researcher interviews and surveys\n* Patients with other reasons rendering study participation inappropriate as judged by the researcher(s)'}, 'identificationModule': {'nctId': 'NCT03293212', 'briefTitle': 'Characteristics and Medical Resource Utilization of Postoperative Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Medical Foundation'}, 'officialTitle': 'Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients', 'orgStudyIdInfo': {'id': 'JS-CT-2017-03'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jaseng Medical Foundation', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Hyuk Ha, KMD, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaseng Medical Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Medical Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Institute of Oriental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'In-Hyuk Ha, KMD', 'investigatorAffiliation': 'Jaseng Medical Foundation'}}}}