Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT03449160
Status:
WITHDRAWN
Last Update Posted:
2020-10-19
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postural Training Device (UPRIGHT) for Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID 19 which is preventing outpatient and elective procedures', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement/Change in Pain', 'timeFrame': 'Primary outcome is at 6 weeks, secondary time point 12 weeks', 'description': '0-10 pain scale'}], 'secondaryOutcomes': [{'measure': 'Improvement/Change Disability', 'timeFrame': '6 weeks, 12 weeks', 'description': 'Modified Oswestry Disability Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain Without Radiation', 'Back Pain, Low']}, 'descriptionModule': {'briefSummary': 'Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device', 'detailedDescription': 'Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device.\n\nPhysical therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.\n\nAt 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions\n* Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation\n* 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation\n* Pain duration of at least 2 months\n* Patient owns and is familiar with the use of a personal smart phone\n* Patient consents to treatment with postural based physical therapy. In order to maintain blinding, patients will not be provided with details of the treatment plan until after the randomization process has been performed. They will only be informed of the treatment protocol for the group to which they have been assigned.\n\nExclusion Criteria:\n\n* \\*History of prior thoracic or lumbar fusion surgery\n\n * Acute Spine fracture\n * Current pregnancy\n * BMI over 40\n * Inability to sense UPRIGHT vibration\n * Active Systemic inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus)\n * Medical conditions causing significant functional disability (e.g. stroke, spinal cord injury, amputation)\n * Severe Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)\n * Severe clinical depression, or psychotic features\n * Implanted electrical medical device (i.e. cardiac pacemaker/defibrillator, spinal cord stimulator, bladder stimulator)\n * Allergic skin reaction to tapes or adhesives\n * Worker's compensation claim or legal action related to the thoracic or lumbar pain\n * Patients unable to read English and complete the assessment instruments\n * Patients unable to attend assigned physical therapy sessions\n * Incarcerated patients"}, 'identificationModule': {'nctId': 'NCT03449160', 'briefTitle': 'Postural Training Device (UPRIGHT) for Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial', 'orgStudyIdInfo': {'id': 'BSCHNEIDERXX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': 'Receive standard physical therapy', 'interventionNames': ['Other: physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'posture training device', 'description': 'Receive a posture training device in addition to standard physical therapy', 'interventionNames': ['Device: UPRIGHT']}], 'interventions': [{'name': 'UPRIGHT', 'type': 'DEVICE', 'description': 'A small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained. The device is removable, and used for only portions of the day', 'armGroupLabels': ['posture training device']}, {'name': 'physical therapy', 'type': 'OTHER', 'description': 'routine physical therapy', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Byron Schneider', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}