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
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
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
NCT ID
NCT03062293
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
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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