Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-26 @ 10:13 PM
Study NCT ID:
NCT02125968
Status:
TERMINATED
Last Update Posted:
2023-08-14
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013995', 'term': 'Time'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-26', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Questionnaire', 'timeFrame': 'changes from baseline at one and three months after treatment'}], 'secondaryOutcomes': [{'measure': 'range of motion', 'timeFrame': 'changes from baseline at one and three months after treatment'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'changes from baseline at one and three months after treatment'}, {'measure': 'postural stability', 'timeFrame': 'changes from baseline at one and three months after treatment', 'description': 'postural stability, limits of stability, and fall risk measured by Biodex Stability System'}, {'measure': 'Fear avoidance Behavior Questionnaire', 'timeFrame': 'changes from baseline at one and three months after treatment'}, {'measure': 'physical activity', 'timeFrame': 'changes from baseline at one and three months after treatment', 'description': 'timed stairs climbing, 10-m walking, chair-rising time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic low back pain', 'video game', 'therapeutic effects'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the video game play therapy in patients with chronic low back pain.', 'detailedDescription': 'Understanding the short- and medium-term therapeutic effects of video game play therapy for patients with chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic low back pain\n\nExclusion Criteria:\n\n1. low back pain accompanied by specific pathological conditions, such as infection, inflammation, fracture, or tumor\n2. history of low back surgery with an implant\n3. pregnancy of plans to become pregnant during the course of study\n4. having received concurrent treatment for low back pain followed by another health care professional'}, 'identificationModule': {'nctId': 'NCT02125968', 'briefTitle': 'Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Therapeutic Effects of Video Game Play Therapy on Patients With Chronic Low Back Pain:Randomized-Controlled Clinical Trail', 'orgStudyIdInfo': {'id': 'SKH-8302-103-DR-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'interactive video game', 'description': 'Participants in interactive video game group receive six 20-min sessions of hot pack therapy combined 20-min of diathermy therapy over the low back followed by 15-min interactive video game intervention, for 3 times per week for a 2-week duration.\n\nShort- and medium-term therapeutic effects of interactive video game intervention for patients with chronic low back pain will be assessed.', 'interventionNames': ['Other: interactive video game']}, {'type': 'SHAM_COMPARATOR', 'label': 'therapeutic exercise', 'description': 'Participants received six 20-min sessions of hot pack therapy combined 20-min of diathermy therapy over the low back followed by 15-min supervised therapeutic exercise,for 3 times per week for a 2-week duration.\n\nshort- and medium-term therapeutic effects of video game play therapy for patients with chronic low back pain will be evaluated.', 'interventionNames': ['Other: therapeutic exercise']}], 'interventions': [{'name': 'interactive video game', 'type': 'OTHER', 'otherNames': ['6 sessions of 15-min, for a 2-week duration'], 'description': 'short- and medium-term therapeutic effects', 'armGroupLabels': ['interactive video game']}, {'name': 'therapeutic exercise', 'type': 'OTHER', 'otherNames': ['6 sessions of 15 min ,for a 2-week duration.'], 'description': 'short- and medium-term therapeutic effects', 'armGroupLabels': ['therapeutic exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111-01', 'city': 'Taipie', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital'}], 'overallOfficials': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}