Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 2:26 PM
Study NCT ID:
NCT02420457
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracking Outcomes in Pain Patients Using Fitness Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001416', 'term': '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': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of percent improvement in pain and number of steps.', 'timeFrame': 'Follow-up assessment approximately 2-4 weeks following epidural procedure.', 'description': 'Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of steps taken on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.'}], 'secondaryOutcomes': [{'measure': 'Change in pain severity following procedure', 'timeFrame': 'Follow-up timepoint approximately 2-4 weeks following procedure', 'description': 'Pain will be assessed by using a Visual Analog Scale (VAS) where scores range from 0 = no pain to 100 = worst possible pain. An increase in pain scores from baseline represent disease progression and decrease represent clinical response to treatment. VAS will be assessed prior to treatment and then at a followup assessment.'}, {'measure': 'Association in minutes slept as measured by fitness device and percent improvement in pain', 'timeFrame': 'Follow-up assessment approximately 2-4 week following procedure', 'description': 'Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of minutes slept on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.'}, {'measure': 'Change in survey measures of pain', 'timeFrame': 'Follow-up assessment approximately 2-4 weeks following the procedure.', 'description': 'Conglomerate survey device of brief pain inventory, roland morris disability questionnaire, and oswestry disability index. The investigators will measure baseline survey data before the treatment and then at follow up visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fitness devices'], 'conditions': ['Chronic Pain', 'Back Pain']}, 'descriptionModule': {'briefSummary': 'The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.', 'detailedDescription': 'The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with chronic back pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Back pain which may benefit from epidural injection\n* Assenting to epidural injection for back pain\n\nExclusion Criteria:\n\n* Inability to wear fitness tracking device'}, 'identificationModule': {'nctId': 'NCT02420457', 'briefTitle': 'Tracking Outcomes in Pain Patients Using Fitness Devices', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Tracking Outcomes in Pain Patients Using Fitness Devices', 'orgStudyIdInfo': {'id': '14-2949'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Back pain receiving epidural injection', 'description': 'Patients who have chronic back pain and are scheduled for an epidural injection to treat this pain will be receive a transforaminal epidural steroid injection as determined by routine care provider', 'interventionNames': ['Procedure: Epidural injection', 'Drug: Epidural steroid injection as determined by routine care provider']}], 'interventions': [{'name': 'Epidural injection', 'type': 'PROCEDURE', 'description': 'After evaluation by their pain physician, if the clinician offers an epidural injection for their back pain, they will be followed for this study before and after the injection.', 'armGroupLabels': ['Back pain receiving epidural injection']}, {'name': 'Epidural steroid injection as determined by routine care provider', 'type': 'DRUG', 'description': 'Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline', 'armGroupLabels': ['Back pain receiving epidural injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '275997010', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Matthew C Mauck, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}