Newcastle Low Back Pain Intervention Study

NCT03062293 | Unknown

• 1 other identifier: FRED2016
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain, Mechanical

Keywords

Lumbo-pelvic muscles; Rehabilitation; Exercise; Low back pain; Functional Re-adaptive Exercise Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• VICON/ force plate kinematic data

  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 .

  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

  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 Outcomes (1)

• 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)

Study Arms (1)

Functional Re-adaptive Exercise Device

EXPERIMENTAL

Single arm for within subject repeated measures design.

Device: Functional Re-adaptive Exercise Device

Interventions

Functional Re-adaptive Exercise Device 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.

Also known as: FRED

Functional Re-adaptive Exercise Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• European Space Agency: collaborator
• The University of Queensland: collaborator
• International Space University: collaborator
• Aalborg University: collaborator

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 22789062 BACKGROUND

• 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.

  PMID: 24139004 BACKGROUND

• 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.

  PMID: 25022167 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Ultrasound image time points are blinded to the assessor by a party not involved in the study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeat measures within subject design

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share