Low Back Pain, Mechanical
Conditions
Keywords
Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device
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 1. whether FRED exercise reduces mechanical LBP ( low back pain); 2. whether FRED exercise improves functional and static balance in people with LBP; 3. whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles; 4. 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; 5. whether FRED exercise has an effect on TrA and internal oblique muscle thickness; 6. the rate of muscle physiology change in response to FRED exercise in people with LBP; 7. whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP; 8. whether FRED exercise affects wellbeing and every-day function in people with LBP; 9. the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.
Interventions
DEVICEFunctional Re-adaptive Exercise Device
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.
Sponsors
European Space Agency
The University of Queensland
International Space University
Aalborg University
Northumbria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Ultrasound image time points are blinded to the assessor by a party not involved in the study
Intervention model description
Repeat measures within subject design
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intramuscular EMG of Lumbo-pelvic muscles | within 1 week prior to intervention, and within 1 week post intervention (2 data collection | iEMG of Lumbar Multifudus (LM), Transversus Abdominus (TrA), External Obliques and Internal obliques during exercise and balance tasks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscular arcitecture via Ultrasound imaging | 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) | USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA) |
| VICON/ force plate kinematic data | within 1 week prior to intervention and and within 1 week post intervention (2 data collections) | Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study |
| Participant Activity Log | Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days) | — |
| Patient Specific Functional Scale | 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) | repeated measure throughout study |
| Numeric Rating Scale for Pain | 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) | — |
| SF-36 II . | 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) | Version 2, UK, acute recall |
Other
| Measure | Time frame | Description |
|---|---|---|
| Movement variability during exercise | 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) | Changes in neuromuscular control during FRED exercise |
Outcome results
None listed