Newcastle Low Back Pain Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain, Mechanical
- Sponsor
- Northumbria University
- Enrollment
- 14
- Primary Endpoint
- Change in Intramuscular EMG of Lumbo-pelvic muscles
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Intramuscular EMG of Lumbo-pelvic muscles
Time Frame: 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 Outcomes
- 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))
- 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))
- Participant Activity Log(Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days))
- VICON/ force plate kinematic data(within 1 week prior to intervention and and within 1 week post intervention (2 data collections))
- 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))
- 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))