Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-21 @ 9:07 PM
Study NCT ID:
NCT03062293
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Newcastle Low Back Pain Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Ultrasound image time points are blinded to the assessor by a party not involved in the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Repeat measures within subject design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Movement variability during exercise', 'timeFrame': 'At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, 3 x week during intervention, at intervention +6 weeks and +12 weeks follow up (22 data collections)', 'description': 'Changes in neuromuscular control during FRED exercise'}], 'primaryOutcomes': [{'measure': 'Change in Intramuscular EMG of Lumbo-pelvic muscles', 'timeFrame': 'within 1 week prior to intervention, and within 1 week post intervention (2 data collection', 'description': 'iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks'}], 'secondaryOutcomes': [{'measure': 'Change in muscular arcitecture via Ultrasound imaging', 'timeFrame': 'At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, 1 x week during intervention, and at intervention +12 weeks (10 data collections)', 'description': 'USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA)'}, {'measure': 'VICON/ force plate kinematic data', 'timeFrame': 'within 1 week prior to intervention and and within 1 week post intervention (2 data collections)', 'description': 'Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study'}, {'measure': 'Participant Activity Log', 'timeFrame': 'Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)'}, {'measure': 'SF-36 II .', 'timeFrame': 'At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)', 'description': 'Version 2, UK, acute recall'}, {'measure': 'Patient Specific Functional Scale', 'timeFrame': 'At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)', 'description': 'repeated measure throughout study'}, {'measure': 'Numeric Rating Scale for Pain', 'timeFrame': 'At baseline (intervention -6 weeks) within 1 week prior to intervention, within 1 week post intervention, at intervention +6 week, +12 weeks and +16 weeks follow up (5 data collections)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lumbo-pelvic muscles', 'Rehabilitation', 'Exercise', 'Low back pain', 'Functional Re-adaptive Exercise Device'], 'conditions': ['Low Back Pain, Mechanical']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Caplan, N, Gibbon, KC, Hibbs, A & Debuse, D 2014, 'Phasic-to-tonic shift in tunk muscle activity during low-impact weight bearing exercise', Acta Astronautica, vol 104, pp. 388-395."}, {'pmid': '22789062', 'type': 'BACKGROUND', 'citation': 'Debuse D, Birch O, St Clair Gibson A, Caplan N. Low impact weight-bearing exercise in an upright posture increases the activation of two key local muscles of the lumbo-pelvic region. Physiother Theory Pract. 2013 Jan;29(1):51-60. doi: 10.3109/09593985.2012.698718. Epub 2012 Jul 12.'}, {'pmid': '24139004', 'type': 'BACKGROUND', 'citation': 'Gibbon KC, Debuse D, Caplan N. Low impact weight-bearing exercise in an upright posture achieves greater lumbopelvic stability than overground walking. J Bodyw Mov Ther. 2013 Oct;17(4):462-8. doi: 10.1016/j.jbmt.2013.02.004. Epub 2013 Apr 22.'}, {'pmid': '25022167', 'type': 'BACKGROUND', 'citation': 'Evetts SN, Caplan N, Debuse D, Lambrecht G, Damann V, Petersen N, Hides J. Post space mission lumbo-pelvic neuromuscular reconditioning: a European perspective. Aviat Space Environ Med. 2014 Jul;85(7):764-5. doi: 10.3357/asem.3943.2014.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.', 'detailedDescription': 'The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes.\n\nThe objectives of this study are to examine\n\n1. whether FRED exercise reduces mechanical LBP ( low back pain);\n2. whether FRED exercise improves functional and static balance in people with LBP;\n3. whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;\n4. whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP;\n5. whether FRED exercise has an effect on TrA and internal oblique muscle thickness;\n6. the rate of muscle physiology change in response to FRED exercise in people with LBP;\n7. whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;\n8. whether FRED exercise affects wellbeing and every-day function in people with LBP;\n9. the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical LBP for 8 weeks or longer\n* Score of \\< 15 on FABQ\n* Age 18-60\n* Commitment to taking part in the study for its full duration\n\nExclusion Criteria:\n\n* Presence of "red flags" - indicative of non-mechanical LBP\n* Score of \\> 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP\n* Exercise contraindicated as per Physical Activity Readiness Questionnaire\n* Inability to exercise safely on the FRED\n* Pregnancy\n* Surgery within the previous nine months\n* Difficulty to exercise safely in standing for 30 mins 3x/week\n* Cardio/respiratory disease\n* Neurological disorders\n* BMI \\> 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement'}, 'identificationModule': {'nctId': 'NCT03062293', 'briefTitle': 'Newcastle Low Back Pain Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Newcastle Low Back Pain Intervention Study', 'orgStudyIdInfo': {'id': 'FRED2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional Re-adaptive Exercise Device', 'description': 'Single arm for within subject repeated measures design.', 'interventionNames': ['Device: Functional Re-adaptive Exercise Device']}], 'interventions': [{'name': 'Functional Re-adaptive Exercise Device', 'type': 'DEVICE', 'otherNames': ['FRED'], 'description': 'Exercise intervention 3 times per week for up to 30min. Difficulty and time will be progressed as indicated by clinical presentation, assessed by the Physiotherapist team.', 'armGroupLabels': ['Functional Re-adaptive Exercise Device']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NO IPD will be available to researchers outside of the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Space Agency', 'class': 'OTHER'}, {'name': 'The University of Queensland', 'class': 'OTHER'}, {'name': 'International Space University', 'class': 'UNKNOWN'}, {'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}