Newcastle Low Back Pain Intervention Study

Not Applicable

• Conditions: Low Back Pain, Mechanical
• Interventions: Device: Functional Re-adaptive Exercise Device

• Registration Number: NCT03062293
• Lead Sponsor: Northumbria University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-11
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Re-adaptive Exercise Device	Functional Re-adaptive Exercise Device	Single arm for within subject repeated measures design.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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)	Measuring postural sway changes in center of pressure during the balance and rapid arm movement tasks, repeated measure throughout study
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)