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Trial registered on ANZCTR


Registration number
ACTRN12618002001279p
Ethics application status
Submitted, not yet approved
Date submitted
31/10/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do different types of exercise help educational messages provided to people with chronic low back pain?
Scientific title
How should exercise-based practitioners provide interventions to compliment pain education, to achieve adherence and clinically meaningful reductions in pain and pain-related disability?
Secondary ID [1] 296481 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 310265 0
Condition category
Condition code
Musculoskeletal 308995 308995 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive full-body resistance training combined with pain neuroscience education, underpinned by principles of cognitive behavioural therapy. This will involve one session per week for a duration of 8-weeks. The sessions will be one hour in duration and contain 45mins of exercise, 10mins of education, and 5mins of questions/reflections. Topics covered in the education will focus around the physiology of pain and how this can be used to understand persistent pain. Moreover, the education will include understanding of how the emotional state can influence pain manifestation, as per the biopsychosocial model. This will be done in small groups (1 facilitator, with 4 participants). No physical information will be used - these will be discussion based format.

Resistance training component (in the same 1:4 group ratio).
Sessions will commence with a dynamic warm up such as walking/jogging/rowing.
Sessions will be a full-body design with exercise selection based around the following movement patterns:
- Vertical Pull
- Vertical Push
- Horizontal Pull
- Horizontal Push
- Squat
- Bend
- Lunge

Session intensity for week 1 will be low, as it will primarily be used to 'teach' exercises.
Weeks 2-5 will have a higher session volume (repetition range 12-15) with lower overall intensity as gauged initially by an RPE scale (6/10) or working approximately 4-repetitions from failure.
Weeks 6 and 7 will see a decrease in repetitions (8-10), with an increase in loading (8RPE).
Week 8 will see a further undulation in Volume and intensity with a reduction of repetition range to 5-8 repetitions at 9RPE.

These sessions will be facilitated in a gym environment by Accredited Exercise Scientists/Physiologists who are also dual qualified as strength and conditioning coaches. Home-based sessions will be prescribed for 2-other days per week. Home-based sessions will contain the same movement patterns as the supervised session, however, without loading due to not being in a gym-based environment. Where external loading is needed (e.g. a vertical pull), a light resistance band will be used.

Adherence to supervised sessions will be monitored with attendance. Adherence to home-based sessions will be monitored through training diaries.
Intervention code [1] 312804 0
Rehabilitation
Comparator / control treatment
A general set of calisthenic 'back pain exercises' such as quadruped, partial curl up, and side bridge, combined with pain neuroscience education, underpinned by principles of cognitive behavioural therapy. This will involve one session per week for a duration of 8-weeks. The pain neuroscience education will be the same as that provided to the intervention group.

The sessions will follow the same format as the intervention group in a gym-based environment and be facilitated by individual's with the same level of qualification in exercise science and strength and conditioning. Home-based sessions will be prescribed for 2-other days per week. Home-based sessions will be the same as the supervised session.

Adherence to supervised sessions will be monitored with attendance. Adherence to home-based sessions will be monitored through training diaries.
Control group
Active

Outcomes
Primary outcome [1] 307954 0
Low back Pain (VAS scale)
- Current pain
Timepoint [1] 307954 0
8-weeks post intervention commencement
Primary outcome [2] 308390 0
Pain-related disability (Oswestry Disability Scale)
Timepoint [2] 308390 0
8-weeks post intervention commencement
Primary outcome [3] 308416 0
Pain intensity (low back pain) VAS Scale
worst pain in the last week
Timepoint [3] 308416 0
Post intervention (8-weeks after commencement)
Secondary outcome [1] 353453 0
Functional Self-efficacy (FSE) (FSE sub-scale of the chronic pain self-efficacy scale)
Timepoint [1] 353453 0
8-weeks post intervention commencement
Secondary outcome [2] 354843 0
Fear avoidance beliefs (fear avoidance beliefs questionnaire)
Timepoint [2] 354843 0
8-weeks post intervention commencement
Secondary outcome [3] 354844 0
Pain catastrophizing (pain catasrophizing scale)
Timepoint [3] 354844 0
8-weeks post intervention commencement
Secondary outcome [4] 354845 0
Anxiety and depression (Hospital anxiety and depression scale)
Timepoint [4] 354845 0
8-weeks post intervention commencement

Eligibility
Key inclusion criteria
Pain in the lower back for more than 3-months, no history of spinal surgery, spinal abnormality, or daily pain that radiates into the lower leg.
No existing signs or symptoms of cardiovascular, pulmonary, metabolic, or neurological disease, and/or a recent diagnosis of mental illness.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk as per the exercise and sport science Australia (ESSA) pre-screening document

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of co-variance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 24508 0
2560 - Campbelltown
Recruitment postcode(s) [2] 24509 0
2565 - Ingleburn
Recruitment postcode(s) [3] 24510 0
2570 - Camden
Recruitment postcode(s) [4] 24511 0
2567 - Mount Annan
Recruitment postcode(s) [5] 24512 0
2567 - Narellan
Recruitment postcode(s) [6] 24513 0
2566 - Minto
Recruitment postcode(s) [7] 24514 0
2563 - Menangle Park
Recruitment postcode(s) [8] 24515 0
2564 - Macquarie Fields
Recruitment postcode(s) [9] 24516 0
2567 - Narellan Vale
Recruitment postcode(s) [10] 24517 0
2567 - Narellan Dc
Recruitment postcode(s) [11] 24518 0
2567 - Smeaton Grange
Recruitment postcode(s) [12] 24519 0
2568 - Menangle
Recruitment postcode(s) [13] 24520 0
2569 - Douglas Park
Recruitment postcode(s) [14] 24521 0
2559 - Blairmount
Recruitment postcode(s) [15] 24522 0
2559 - Claymore
Recruitment postcode(s) [16] 24523 0
2558 - Eagle Vale
Recruitment postcode(s) [17] 24524 0
2558 - Kearns
Recruitment postcode(s) [18] 24525 0
2557 - Catherine Field
Recruitment postcode(s) [19] 24526 0
2557 - Gregory Hills
Recruitment postcode(s) [20] 24527 0
2557 - Gledswood Hills
Recruitment postcode(s) [21] 24528 0
2560 - Airds
Recruitment postcode(s) [22] 24529 0
2560 - Ambarvale
Recruitment postcode(s) [23] 24530 0
2560 - Appin
Recruitment postcode(s) [24] 24531 0
2560 - Blair Athol
Recruitment postcode(s) [25] 24532 0
2560 - Campbelltown North
Recruitment postcode(s) [26] 24533 0
2560 - Bradbury
Recruitment postcode(s) [27] 24534 0
2560 - Cataract
Recruitment postcode(s) [28] 24535 0
2560 - Englorie Park
Recruitment postcode(s) [29] 24536 0
2560 - Gilead
Recruitment postcode(s) [30] 24537 0
2560 - Kentlyn
Recruitment postcode(s) [31] 24538 0
2560 - Glen Alpine
Recruitment postcode(s) [32] 24539 0
2560 - Leumeah
Recruitment postcode(s) [33] 24540 0
2560 - Macarthur Square
Recruitment postcode(s) [34] 24541 0
2560 - Rosemeadow
Recruitment postcode(s) [35] 24542 0
2560 - Ruse
Recruitment postcode(s) [36] 24543 0
2560 - St Helens Park
Recruitment postcode(s) [37] 24544 0
2560 - Wedderburn
Recruitment postcode(s) [38] 24545 0
2560 - Woodbine
Recruitment postcode(s) [39] 24546 0
2555 - Badgerys Creek

Funding & Sponsors
Funding source category [1] 301069 0
University
Name [1] 301069 0
Western Sydney University
Address [1] 301069 0
Building 20, Brian Smith Avenue, Campbelltown Campus, 2560, NSW
Country [1] 301069 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Building 20, Brian Smith Avenue, Campbelltown Campus, 2560, NSW
Country
Australia
Secondary sponsor category [1] 300678 0
None
Name [1] 300678 0
Address [1] 300678 0
Country [1] 300678 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301824 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 301824 0
Human Ethics Officer
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 301824 0
Australia
Date submitted for ethics approval [1] 301824 0
05/11/2018
Approval date [1] 301824 0
Ethics approval number [1] 301824 0

Summary
Brief summary
This intervention looks to provide the same pain neuroscience education to both groups, while one receives full-body progressive resistance training and the other general calisthenic 'back pain' exercises. The objective is to observe if either intervention better compliments the messages provided with pain education.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88230 0
Mr Mitchell Gibbs
Address 88230 0
Western Sydney University
Building 20, room 35, Campbelltown Campus
Locked Bag 1797 Penrith NSW 2751

Country 88230 0
Australia
Phone 88230 0
+61 246203917
Fax 88230 0
Email 88230 0
mitchell.gibbs@westernsydney.edu.au
Contact person for public queries
Name 88231 0
Mr Mitchell Gibbs
Address 88231 0
Western Sydney University
Building 20, room 35, Campbelltown Campus
Locked Bag 1797 Penrith NSW 2751

Country 88231 0
Australia
Phone 88231 0
+61 246203917
Fax 88231 0
Email 88231 0
mitchell.gibbs@westernsydney.edu.au
Contact person for scientific queries
Name 88232 0
Mr Mitchell Gibbs
Address 88232 0
Western Sydney University
Building 20, room 35, Campbelltown Campus
Locked Bag 1797 Penrith NSW 2751

Country 88232 0
Australia
Phone 88232 0
+61 246203917
Fax 88232 0
Email 88232 0
mitchell.gibbs@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
This will be decided through the HREC review process.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Not applicable