Newcastle Low Back Pain Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Newcastle Low Back Pain Intervention Study

Conditions
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Low Back Pain, Mechanical

Intervention / Treatment
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* Device: Functional Re-adaptive Exercise Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Repeat measures within subject design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Re-adaptive Exercise Device<br>Single arm for within subject repeated measures design. | Device: Functional Re-adaptive Exercise Device<br>* 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.<br>* Other names: FRED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 1 week prior to intervention, and within 1 week post intervention (2 data collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscular arcitecture via Ultrasound imaging | USI of cross sectional area and thickness of Lumbar Multifudus (LM),and thickness of Transversus Abdominus (TrA) | 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) | 
| 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 | within 1 week prior to intervention and and within 1 week post intervention (2 data collections) | 
| Participant Activity Log |  | Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days) | 
| SF-36 II . | Version 2, UK, acute recall | 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) | 
| Patient Specific Functional Scale | repeated measure throughout study | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbo-pelvic muscles, Rehabilitation, Exercise, Low back pain, Functional Re-adaptive Exercise Device