Newcastle Low Back Pain Intervention Study

NCT ID: NCT03062293

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

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

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.

Conditions

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Low Back Pain, Mechanical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repeat measures within subject design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Ultrasound image time points are blinded to the assessor by a party not involved in the study

Study Groups

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Functional Re-adaptive Exercise Device

Single arm for within subject repeated measures design.

Group Type EXPERIMENTAL

Functional Re-adaptive Exercise Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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FRED

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Space Agency

OTHER

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role collaborator

International Space University

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 22789062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24139004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25022167 (View on PubMed)

Other Identifiers

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FRED2016

Identifier Type: -

Identifier Source: org_study_id

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