Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-18 @ 4:32 AM
Study NCT ID:
NCT02284958
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Walking Away From Back Pain, One Step at a Time
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-04', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oswestry Low Back Pain Disability Questionnaire score', 'timeFrame': 'Baseline, 12 weeks, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in mean number of steps per day for each week of the study', 'timeFrame': 'Baseline & 12 weeks'}, {'measure': 'Change in six minute walk test', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in International Physical Activity Questionnaire score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in Fear Avoidance Beliefs Questionnaire score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in Back Beliefs Questionnaire score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in Exercise Self-efficacy Scale score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in Global rating of change for physical activity score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months'}, {'measure': 'Change in Euroqual-5D score', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months', 'description': 'Quality of life'}, {'measure': 'Change in health care usage and intervention costs over time', 'timeFrame': 'Baseline, 12 weeks, 6 months & 12 months', 'description': 'Participant records health care usage and intervention costs over the 12 month study'}, {'measure': 'Focus group data', 'timeFrame': 'Following 12 week intervention', 'description': 'Walking group only, voluntary participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['walking', 'pedometer'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '33607979', 'type': 'DERIVED', 'citation': 'Lang AE, Hendrick PA, Clay L, Mondal P, Trask CM, Bath B, Penz ED, Stewart SA, Baxter GD, Hurley DA, McDonough SM, Milosavljevic S. A randomized controlled trial investigating effects of an individualized pedometer driven walking program on chronic low back pain. BMC Musculoskelet Disord. 2021 Feb 19;22(1):206. doi: 10.1186/s12891-021-04060-8.'}, {'pmid': '25885913', 'type': 'DERIVED', 'citation': 'Milosavljevic S, Clay L, Bath B, Trask C, Penz E, Stewart S, Hendrick P, Baxter GD, Hurley DA, McDonough SM. Walking away from back pain: one step at a time - a community-based randomised controlled trial. BMC Public Health. 2015 Feb 13;15:144. doi: 10.1186/s12889-015-1496-9.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate if a 12-week, individually-tailored walking program, using pedometers will be a more clinically and cost-effective option for the management of chronic low back pain than standardized advice and education.', 'detailedDescription': 'Specific objectives of the study are:\n\n1. To determine perceived levels of disability and baseline levels of walking activity in a sample of those with chronic low back pain (CLBP)\n2. To determine the uptake and adherence to a pedometer-driven walking program for people with CLBP\n3. To test the clinical and cost-effectiveness of a walking programme to improve outcomes for CLBP compared to a standardized back care education package\n4. To test the feasibility of a walking programme in a sub-sample of rural Saskatchewan farmers/agricultural workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females aged 18 years or over,\n* experiencing low back pain (i.e. between the 12th costal margin and gluteal fold with or without associated leg pain) persisting for a minimum of three months, and\n* assessed as capable of participating in a walking programme.\n\nExclusion Criteria:\n\n* any spinal surgery in the past 12 months;\n* evidence of nerve root, spinal cord, or cauda equina compression;\n* severe spinal stenosis indicated by signs of neurogenic claudication, grade 3 to 4 spondylolisthesis, fibromyalgia, or systemic/inflammatory disorder;\n* as well as any other current lower extremity musculoskeletal injury or contraindication to increasing physical activity (PA) levels.\n\nThe latter may include:\n\n* any cardiorespiratory or other medical condition limiting exercise tolerance;\n* history of serious psychological or psychiatric illness (mild depression eligible for inclusion); and/or\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT02284958', 'briefTitle': 'Walking Away From Back Pain, One Step at a Time', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'A Single-centre, Randomized Controlled Trial Investigating Clinical Utility and Cost-effectiveness of an Individualized Pedometer Driven Walking Programme for People With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '14-218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard/Control group', 'description': "Each participant will receive a one-off individualized educational session regarding the management of chronic low back pain with a Physical Therapist: includes a physical examination, standardized advice \\& provision of the 'Back Book'.", 'interventionNames': ['Behavioral: Standard']}, {'type': 'EXPERIMENTAL', 'label': 'Walking group', 'description': 'Each participant will receive a one-off educational session as per standard/control group followed by a 12 week graded, individually tailored, pedometer driven walking programme given by a Physical Therapist. Participants will be monitored each week and provided with encouragement and advice to increase the number of steps taken each day.', 'interventionNames': ['Behavioral: Walking']}], 'interventions': [{'name': 'Standard', 'type': 'BEHAVIORAL', 'description': 'Back care advice', 'armGroupLabels': ['Standard/Control group']}, {'name': 'Walking', 'type': 'BEHAVIORAL', 'description': 'Back care advice, individualized 12 week pedometer-driven walking program', 'armGroupLabels': ['Walking group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0T3', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Stephan Milosavljevic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ulster', 'class': 'OTHER'}, {'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'University of Otago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephan Milosavljevic', 'investigatorAffiliation': 'University of Saskatchewan'}}}}