Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 12:09 AM
Study NCT ID:
NCT05573932
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-10', 'releaseDate': '2025-03-24'}], 'estimatedResultsFirstSubmitDate': '2025-03-24'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-08', 'size': 676728, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-28T14:50', 'hasProtocol': True}, {'date': '2022-09-09', 'size': 3405530, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-28T14:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be randomized into the two separate groups using a random number generator and allocation will be concealed in opaque envelopes prior to data collection.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Change from baseline to 3 weeks', 'description': 'Assessed by the numeric pain rating scale'}, {'measure': 'Change in pain', 'timeFrame': 'Change from baseline to 6 weeks', 'description': 'Assessed by the numeric pain rating scale'}, {'measure': 'Change in pain', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Assessed by the numeric pain rating scale'}, {'measure': 'Change in pain', 'timeFrame': 'Change from baseline to 18 months', 'description': 'Assessed by the numeric pain rating scale'}, {'measure': 'Change in Disability', 'timeFrame': 'Change from baseline to 3 weeks', 'description': 'Assessed with the Oswestry Disability Index'}, {'measure': 'Change in Disability', 'timeFrame': 'Change from baseline to 6 weeks', 'description': 'Assessed with the Oswestry Disability Index'}, {'measure': 'Change in Disability', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Assessed with the Oswestry Disability Index'}, {'measure': 'Change in Disability', 'timeFrame': 'Change from baseline to 18 months', 'description': 'Assessed with the Oswestry Disability Index'}, {'measure': 'Adherence', 'timeFrame': 'Change from baseline to 3 weeks', 'description': 'Assessed by the exercise adherence rating scale'}, {'measure': 'Adherence', 'timeFrame': 'Change from baseline to 6 weeks', 'description': 'Assessed by the exercise adherence rating scale'}, {'measure': 'Change in Muscle thickness of the lateral abdominal wall', 'timeFrame': 'Change from baseline to 6 weeks', 'description': 'Assessed with ultrasound during static positions and exercise starting positions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-specific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '38899776', 'type': 'DERIVED', 'citation': 'Devorski L, Suppiah A, Fukuda DH, Stout J, Ingersoll CD, Mangum LC. Gamified delivery of at-home rehabilitation for individuals with nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(6):1416-1422. doi: 10.1080/09638288.2024.2368694. Epub 2024 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'Two groups with non-specific low back pain will be completing the same exercise protocol. The leaderboard group will have a gamified experience and the take-home packet group will be using a paper take-home packet. Outcomes will be measured at 3 weeks, 6 weeks, with pain and disability also being measured at 12 and 18 months.', 'detailedDescription': 'There will be two groups in this study, the leaderboard group, and the take-home packet group. The leaderboard group and the take-home packet group will be completing the same exercise program throughout the 6-weeks. The exercises included the plank, side plank (left and right side), foot elevated (left and right side), dead bug and bird dog exercise until discontinuation. The exercises will increase with repetitions every two weeks and that outline is listed below in procedures involved. The leaderboard group will have on demand video access to the exercises and the take-home packet group will have a take-home packet. The leaderboard group will also be receiving weekly leaderboards of average and top exercise durations of the leaderboard group participants. The audio description of exercise in the on-demand video group is the same script as the written description in the take-home packet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18-45 years old\n* Biological sex of Male or Female\n* Self-reported low back pain within the previous 6 months or greater than 3 episodes within the past 3 years\n\nExclusion Criteria:\n\n* Must not be currently seeing and or receiving care from an athletic trainer, physical therapist, or other rehabilitation specialist in the previous 6 months\n* Must not have low back pain conditions such as lumbar spondylosis, herniated disc, spondylolisthesis, previous spine surgery, currently pregnant, experiencing neurological symptoms or other muscular abnormalities\n* Unable to assume the exercise starting position\n* Current use of lidocaine patches or prescription pain medicine'}, 'identificationModule': {'nctId': 'NCT05573932', 'briefTitle': 'Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain', 'orgStudyIdInfo': {'id': '00004656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leaderboard group', 'description': 'The group that has access to weekly leaderboards and on-demand videos.', 'interventionNames': ['Other: Leaderboard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Take-home packet group', 'description': 'The group that has access to paper take-home packets.', 'interventionNames': ['Other: Take-home packet']}], 'interventions': [{'name': 'Leaderboard', 'type': 'OTHER', 'description': 'De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.', 'armGroupLabels': ['Leaderboard group']}, {'name': 'Take-home packet', 'type': 'OTHER', 'description': 'Take-home packet of exercises.', 'armGroupLabels': ['Take-home packet group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32816', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'READY Laboratory, Education Complex', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-24', 'type': 'RELEASE'}, {'date': '2025-04-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Central Florida'}}}}