Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000229976
Ethics application status
Approved
Date submitted
2/03/2011
Date registered
3/03/2011
Date last updated
3/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise rehabilitation programs for chronic low back pain
Scientific title
In patients with chronic non-specific low back pain, are core stability exercise programs as good or better than general exercise for relief of pain
Secondary ID [1] 259716 0
University of Western Sydney HREC Approval Number H8878
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain 261295 0
Condition category
Condition code
Musculoskeletal 259442 259442 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 259454 259454 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8-week exercise rehabilitation program. Pilates based exercise involving stretching, floor based exercise, reformer based whole body exercise. Prescription is 3 x 1 hours sessions per week for 8-weeks. All directly supervised in a group format (10 people per group session).
Intervention code [1] 264143 0
Rehabilitation
Comparator / control treatment
General exercise group. 3 x 1 hour sessions per week for 8-weeks. Group session (10 per group) directly supervised by an instructor. Intervention to include cycling at 70% maximal heart rate, intermittent walking and stepping tasks, lower limb stretching work.
Control group
Active

Outcomes
Primary outcome [1] 262250 0
Low back pain (Visual Analogue Pain Scale)
Timepoint [1] 262250 0
Baseline (pre) and 8-weeks (post program)
Primary outcome [2] 262264 0
Oswestry disabilty index for low back pain related functional capacity (ODI)
Timepoint [2] 262264 0
Baseline (pre) and 8-weeks (post program)
Primary outcome [3] 262265 0
Abdominal feedforward activation measured using surface electromyography. Test used is a rapid shoulder movement task. Onset of abdominal muscles relative to deltoid prime mover is used for analysis
Timepoint [3] 262265 0
Baseline (pre) and 8-weeks (post program)
Secondary outcome [1] 273387 0
Fear of movement associated with back pain measured with the Fear Avoidance Beliefs Questionnaire (FABQ).
Timepoint [1] 273387 0
Baseline (pre) and 8-weeks (post program)
Secondary outcome [2] 273424 0
Self-rated anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS
Timepoint [2] 273424 0
Baseline (pre) and 8-weeks (post program)
Secondary outcome [3] 273425 0
Beliefs about pain assessed using the Pain Catastrophizing Scale (PCS)
Timepoint [3] 273425 0
Baseline (pre) and 8-weeks (post program)

Eligibility
Key inclusion criteria
Male and female participants with chronic non-specific low back pain. This group excludes those with specific low back pathologies (as assessed from described history of
participants), which introduces confounding factors for interpretation of the results.
Participants will have had LBP for at least 12 weeks and have provided written informed consent confirming
their participation. Participants must have a minimum level of disability caused by their LBP that scores at
least 15% in the Oswestry Functional Disability Index (ODI) to be included in the study. This will discriminate
the level of disability from that experienced by the normal population.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded for the following reasons: presence of severe postural abnormality or
neuromuscular disorder, previous diagnosis of pathology (confirmed by previous magnetic resonance
imaging or radiograph), presence of pain radiating below the knee with a passive straight leg raise indicating
disc and nerve involvement.
Participants must not have engaged in any specific core stability training program in the last 3-months, and
must not be regularly seeing a physiotherapist or any spinal manipulation practitioner.

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?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264596 0
University
Name [1] 264596 0
University of Western Sydney
Country [1] 264596 0
Australia
Primary sponsor type
Individual
Name
Dr. Paul Marshall
Address
University of Western Sydney
Locked Bag 1797 Penrith South 2751, NSW
Country
Australia
Secondary sponsor category [1] 263735 0
Individual
Name [1] 263735 0
Dr. Chris Lonsdale
Address [1] 263735 0
University of Western Sydney
Locked Bag 1797 Penrith South 2751, NSW
Country [1] 263735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260592 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 260592 0
Ethics committee country [1] 260592 0
Australia
Date submitted for ethics approval [1] 260592 0
Approval date [1] 260592 0
Ethics approval number [1] 260592 0
H8878

Summary
Brief summary
Of significant concern for healthcare treatment costs around the world are those individuals
with chronic low back pain (LBP). While exercise is a first-choice treatment for LBP there is no
consensus on the best type of exercise to use, with all modes of exercise equally effective.
Core stability exercises are movements for the trunk with bodyweight resistance. Core stability
training is thought to be the most effective exercise mode to improve neuromuscular control of
the trunk, however research evidence to support this is lacking. Improving neuromuscular
control of the trunk is one of the primary physiological mechanisms by which improvement in
low back pain patients is observed.
There is a lack of research comparing core stability training to other modes of exercise for low
back pain. If the literature reviews are indeed correct that no one mode of exercise is superior
to any other, it may be likely that an exclusively aerobic training modality may be just as
effective as a core stability program for improving pain, disabilty, fear avoidance, and
neuromuscular control of the trunk.
The aim of this study is to randomly assign participants with chronic low back pain to an 8
week exercise trial of either core stability or general aerobic exercise. Both groups will be
directly supervised, and measurements of pain, disability, fear avoidance beliefs, and trunk
neuromuscular control will be made before and after the 8 week program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32298 0
Address 32298 0
Country 32298 0
Phone 32298 0
Fax 32298 0
Email 32298 0
Contact person for public queries
Name 15545 0
Dr. Paul Marshall
Address 15545 0
University of Western Sydney,
Locked Bag 1797 Penrith South 2751, NSW
Country 15545 0
Australia
Phone 15545 0
+61 2 4620 3915
Fax 15545 0
Email 15545 0
[email protected]
Contact person for scientific queries
Name 6473 0
Dr. Paul Marshall
Address 6473 0
University of Western Sydney,
Locked Bag 1797 Penrith South 2751, NSW
Country 6473 0
Australia
Phone 6473 0
+61 2 4620 3915
Fax 6473 0
Email 6473 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.