Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT06749912
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2024-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device use satisfaction', 'timeFrame': 'At the end of the 2-week device use period.', 'description': 'At the conclusion of the 2-week device use period the participants will fill out a device satisfaction survey examining their experience with the device.\n\n25 question survey on how they felt the device worked. Most questions are on a 5-point Likert scale from "strongly agree" to "strongly disagree". The directionality changes based upon the question.\n\nExample:\n\nI could more easily complete daily tasks without pain during the study period when I used the device.\n\n1. Strongly Agree\n2. Agree\n3. Neither Agree nor Disagree\n4. Disagree\n5. Strongly Disagree'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Patients will report their level of pain daily and reflect on their pain over the past over the past 1-week at the start of the study and past 2-weeks during the follow-up surveys\n\nPain Scale: 1-10, higher score = more pain.'}, {'measure': 'Function survey', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Function will be assessed daily and every 2-weeks by survey.'}, {'measure': 'Function test', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Function will be assessed every 2-weeks by a function screening via 5-repitition sit-to-stand.\n\nFunction Scale: 5 point scale from "not at all" to "very much" indicating how much pain interfered with day-to-day activities.'}], 'secondaryOutcomes': [{'measure': 'Medication usage', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Daily screening and every 2-weeks the participants will be asked about what prescription and over-the-counter medications, along with cannabis and THC, were used to help mediate the pain.'}, {'measure': 'Other pain and rehabilitation use', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Participants will be surveyed daily and every 2-weeks about any other type of rehabilitation they used to help mediate their pain.'}, {'measure': 'Device use- Frequency', 'timeFrame': 'For the 2-week device use period.', 'description': 'Frequency of use will be recorded daily during the 2-week device intervention period\n\nFrequency scale: 0-5+ on a 6 point scale indicating how often the device was used per day.'}, {'measure': 'Device use- Duration', 'timeFrame': 'For the 2-week device use period.', 'description': 'Duration of use will be recorded daily during the 2-week device intervention period\n\nScale: 2 point- default (20-minutes) or more. Free response in branching logic to insert amount of time if more than default.'}, {'measure': 'Device use- Type', 'timeFrame': 'For the 2-week device use period.', 'description': 'Type of use will be recorded daily during the 2-week device intervention period.\n\nScale 1- How worn, gives options for under/over clothes \\& activity, resting, sitting, standing, ADLs, free response.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Low back pain', 'acute low back pain', 'symptom reduction', 'pain sensation'], 'conditions': ['Lower Back Pain', 'Lower Back Pain Chronic', 'Acute Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product.\n\nThe main question this study aims to answer is:\n\n• Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain.\n\nParticipants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.', 'detailedDescription': 'Participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. Participants will be screened for inclusion and exclusion criteria and consented. This study utilizes a counterbalanced cross-over design. Each participant will complete both conditions: 1) Intervention (wrap), or 2) Control (Nothing). A counterbalanced assignment approach will be used to determine the starting condition for each participant (Phase 1). After completion of Phase 1, each participant will complete the remaining condition for Phase 2.\n\nEach phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in Phase 1, 2 weeks in Phase 2). When participants are in the Intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). To support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. The Researchers will administer simple daily surveys to log compliance to treatment.\n\nA pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 20 - 65\n* Males and Females (50-50 split or close)\n* Range of ethnicities\n* Range of BMIs\n\nExclusion Criteria:\n\n* Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention\n* Those currently undergoing rehabilitation treatment for LBP\n* Those with other diagnosed conditions that may preclude them from safely participating\n* Pregnant women\n* Waist less than 26" or greater than 66" due to device limitations'}, 'identificationModule': {'nctId': 'NCT06749912', 'briefTitle': 'Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life', 'orgStudyIdInfo': {'id': 'STUDY00008828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower back pain wrap', 'description': 'During this arm the participants will wear the low back pain wrap device', 'interventionNames': ['Device: Low back pain wrap']}, {'type': 'NO_INTERVENTION', 'label': 'No device', 'description': 'No device will be used, but symptoms and function will be reported'}], 'interventions': [{'name': 'Low back pain wrap', 'type': 'DEVICE', 'description': 'The low back pain wrap device includes heat, vibration, and red light to assist with reducing pain sensation, improving function.', 'armGroupLabels': ['Lower back pain wrap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Kyle J Kelleran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Kyle Kelleran', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}