Newcastle Low Back Pain Intervention Study

Low Back Pain, Mechanical Clinical Trial

Official title:

Newcastle Low Back Pain Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03062293
• Other study ID #: FRED2016
• Status: Active, not recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: February 20, 2017
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Northumbria University	Aalborg University, European Space Agency, International Space University, The University of Queensland

References & 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	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)
Secondary	Participant Activity Log		Daily from baseline data collection to intervention +16 weeks follow-up (total 203 days)
Secondary	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)
Secondary	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)
Secondary	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)