Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02960269
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2016-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient experience with telehealth', 'timeFrame': '2-4 weeks after assessment'}, {'measure': 'Pain', 'timeFrame': '2-4 weeks after assessment', 'description': 'Numeric Pain Rating Scale'}, {'measure': 'Back-specific function', 'timeFrame': '2-4 weeks after assessment', 'description': 'Modified Oswestry Disability Index'}, {'measure': 'Participant satisfaction', 'timeFrame': '2-4 weeks after assessment', 'description': 'Modified VSQ-9'}], 'secondaryOutcomes': [{'measure': 'Health care provider experience', 'timeFrame': 'within 2 weeks of completion of all assessments', 'description': 'experience with telehealth technology'}]}, 'conditionsModule': {'keywords': ['rural health', 'telehealth', 'physiotherapy', 'interprofessional'], 'conditions': ['Back Pain Lower Back Chronic']}, 'descriptionModule': {'briefSummary': 'This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).', 'detailedDescription': 'People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth. The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management. Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov NCT02225535). The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nchronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months\n\nExclusion Criteria:\n\n* People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study."}, 'identificationModule': {'nctId': 'NCT02960269', 'briefTitle': 'Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'orgStudyIdInfo': {'id': 'Bio16-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth team assessment', 'description': 'Team assessment for back pain with nurse practitioner and physical therapist via telehealth', 'interventionNames': ['Other: interprofessional back pain assessment']}], 'interventions': [{'name': 'interprofessional back pain assessment', 'type': 'OTHER', 'description': 'team assessment and education with urban physical therapist and rural nurse practitioner via telehealth', 'armGroupLabels': ['Telehealth team assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W3', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kelsey Trail Health Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Brenna Bath', 'investigatorAffiliation': 'University of Saskatchewan'}}}}