Newcastle Low Back Pain Intervention Study

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Device: Functional Re-adaptive Exercise Device

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Re-adaptive Exercise Device; Single arm for within subject repeated measures design.	Device: Functional 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.; Other Names: FRED

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement variability during exercise	Changes in neuromuscular control during FRED 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)

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: European Space Agency; Aalborg University; The University of Queensland; International Space University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Low back pain; Lumbo-pelvic muscles; Functional Re-adaptive Exercise Device
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FRED2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: NO IPD will be available to researchers outside of the research team.