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Newcastle Low Back Pain Intervention Study

Primary Purpose

Low Back Pain, Mechanical

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Re-adaptive Exercise Device
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mechanical LBP for 8 weeks or longer
  • Score of < 15 on FABQ
  • Age 18-60
  • Commitment to taking part in the study for its full duration

Exclusion Criteria:

  • Presence of "red flags" - indicative of non-mechanical LBP
  • 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
  • Exercise contraindicated as per Physical Activity Readiness Questionnaire
  • Inability to exercise safely on the FRED
  • Pregnancy
  • Surgery within the previous nine months
  • Difficulty to exercise safely in standing for 30 mins 3x/week
  • Cardio/respiratory disease
  • Neurological disorders
  • BMI > 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Functional Re-adaptive Exercise Device

    Arm Description

    Single arm for within subject repeated measures design.

    Outcomes

    Primary Outcome Measures

    Change in Intramuscular EMG of Lumbo-pelvic muscles
    iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks

    Secondary Outcome Measures

    Change in muscular arcitecture via Ultrasound imaging
    USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA)
    VICON/ force plate kinematic data
    Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study
    Participant Activity Log
    SF-36 II .
    Version 2, UK, acute recall
    Patient Specific Functional Scale
    repeated measure throughout study
    Numeric Rating Scale for Pain

    Full Information

    First Posted
    October 11, 2016
    Last Updated
    February 20, 2017
    Sponsor
    Northumbria University
    Collaborators
    European Space Agency, The University of Queensland, International Space University, Aalborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03062293
    Brief Title
    Newcastle Low Back Pain Intervention Study
    Official Title
    Newcastle Low Back Pain Intervention Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northumbria University
    Collaborators
    European Space Agency, The University of Queensland, International Space University, Aalborg University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. The objectives of this study are to examine whether FRED exercise reduces mechanical LBP ( low back pain); whether FRED exercise improves functional and static balance in people with LBP; whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles; 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; whether FRED exercise has an effect on TrA and internal oblique muscle thickness; the rate of muscle physiology change in response to FRED exercise in people with LBP; whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP; whether FRED exercise affects wellbeing and every-day function in people with LBP; the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Mechanical
    Keywords
    Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Repeat measures within subject design
    Masking
    None (Open Label)
    Masking Description
    Ultrasound image time points are blinded to the assessor by a party not involved in the study
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional Re-adaptive Exercise Device
    Arm Type
    Experimental
    Arm Description
    Single arm for within subject repeated measures design.
    Intervention Type
    Device
    Intervention Name(s)
    Functional Re-adaptive Exercise Device
    Other Intervention Name(s)
    FRED
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change in Intramuscular EMG of Lumbo-pelvic muscles
    Description
    iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks
    Time Frame
    within 1 week prior to intervention, and within 1 week post intervention (2 data collection
    Secondary Outcome Measure Information:
    Title
    Change in muscular arcitecture via Ultrasound imaging
    Description
    USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA)
    Time Frame
    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)
    Title
    VICON/ force plate kinematic data
    Description
    Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study
    Time Frame
    within 1 week prior to intervention and and within 1 week post intervention (2 data collections)
    Title
    Participant Activity Log
    Time Frame
    Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)
    Title
    SF-36 II .
    Description
    Version 2, UK, acute recall
    Time Frame
    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)
    Title
    Patient Specific Functional Scale
    Description
    repeated measure throughout study
    Time Frame
    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)
    Title
    Numeric Rating Scale for Pain
    Time Frame
    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)
    Other Pre-specified Outcome Measures:
    Title
    Movement variability during exercise
    Description
    Changes in neuromuscular control during FRED exercise
    Time Frame
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mechanical LBP for 8 weeks or longer Score of < 15 on FABQ Age 18-60 Commitment to taking part in the study for its full duration Exclusion Criteria: Presence of "red flags" - indicative of non-mechanical LBP 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 Exercise contraindicated as per Physical Activity Readiness Questionnaire Inability to exercise safely on the FRED Pregnancy Surgery within the previous nine months Difficulty to exercise safely in standing for 30 mins 3x/week Cardio/respiratory disease Neurological disorders BMI > 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    NO IPD will be available to researchers outside of the research team.
    Citations:
    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.
    Results Reference
    background
    PubMed Identifier
    22789062
    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.
    Results Reference
    background
    PubMed Identifier
    24139004
    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.
    Results Reference
    background
    PubMed Identifier
    25022167
    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.
    Results Reference
    background

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    Newcastle Low Back Pain Intervention Study

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