Clinical trial NCT03062293: Newcastle Low Back Pain Intervention Study
Official title: Newcastle Low Back Pain Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: Lumbo-pelvic muscles
Rehabilitation
Exercise
Low back pain
Functional Re-adaptive Exercise Device
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: European Space Agency
name: The University of Queensland
name: International Space University
name: Aalborg University
First posted: 2017-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeat measures within subject design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Intramuscular EMG of Lumbo-pelvic muscles
timeFrame: within 1 week prior to intervention, and within 1 week post intervention (2 data collection
Secondary outcomes:
measure: Change in muscular arcitecture via Ultrasound imaging
timeFrame: 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)
measure: VICON/ force plate kinematic data
timeFrame: within 1 week prior to intervention and and within 1 week post intervention (2 data collections)
measure: Participant Activity Log
timeFrame: Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)
measure: SF-36 II .
timeFrame: 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)
measure: Patient Specific Functional Scale
timeFrame: 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)
measure: Numeric Rating Scale for Pain
timeFrame: 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:
measure: Movement variability during exercise
timeFrame: 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)
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.