Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000037707
Ethics application status
Approved
Date submitted
10/01/2013
Date registered
14/01/2013
Date last updated
14/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Core stability exercise for patients with back pain
Scientific title
In patients with chronic low back pain, does individualized or general exercise elicit greater reductions in disability and pain? A pilot randomized controlled trial
Secondary ID [1] 281749 0
Nil
Universal Trial Number (UTN)
U1111-1138-3662
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 288058 0
Condition category
Condition code
Musculoskeletal 288431 288431 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 288450 288450 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8-weeks of individualized exercise rehabilitation. Patients are to have two supervised sessions per week with an experienced and trained exercise physiologist of approximately 1-hour duration. The program is tailored to the individual based on interaction between the exercise supervisor and expert practitioner overseeing the intervention following a physical assessment with the patient. Home based exercises are recommended to be performed up to 3 times per week (monitored with a training diary).
Intervention code [1] 286288 0
Rehabilitation
Comparator / control treatment
8-weeks of general exercise rehabilitation. Patients are to have two supervised sessions per week with an experienced and trained exercise physiologist of approximately 1-hour duration. The program is a set series of exercise, the same for all patients in this group, which are based on general recommendations for the type of exercise low back pain patients should perform. Home based exercises are recommended to be performed up to 3 times per week (monitored with a training diary).
Control group
Active

Outcomes
Primary outcome [1] 288599 0
Oswestry Disability Index
Timepoint [1] 288599 0
Baseline and 8-weeks
Primary outcome [2] 288600 0
Visual Analog Pain Scale
Timepoint [2] 288600 0
baseline and 8-weeks
Secondary outcome [1] 300564 0
Sorensen lumbar endurance time (seconds)
Timepoint [1] 300564 0
baseline and 8-weeks

Eligibility
Key inclusion criteria
men and women aged 18 to 50 years with ongoing recurrent low back pain (>12 weeks) located between the costal margins and inferior gluteal folds
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of a severe postural abnormality, pain radiating below the knee, known lumbar disc hernia or fracture, history of back surgery, diagnosed inflammatory joint disease, known severe osteoporosis, known metabolic or neuromuscular disease, pregnancy, or recent (< 3 months) participation in an exercise program or any form of treatment (i.e. manipulation, mobilisation, massage).

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)
Randomization will be conducted by a researcher with no involvement in the assessment protocols or training programs. Participants will be randomly assigned in blocks of 10 with equal number of participants assigned to each group. The allocation sequence was concealed from researchers involved in enrolling and assessing participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence was generated from www.random.org
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 covariance procedures will be used to compare post-intervention dependent variable results between-groups, controlling for the respective baseline score of the analyzed variable.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
3/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286537 0
University
Name [1] 286537 0
University of Western Sydney,
University Project Grant
Country [1] 286537 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797 Penrith South
NSW 2751
Australia
Country
Australia
Secondary sponsor category [1] 285324 0
None
Name [1] 285324 0
Address [1] 285324 0
Country [1] 285324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288607 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 288607 0
Locked Bag 1797 Penrith South
NSW 2751
Australia
Ethics committee country [1] 288607 0
Australia
Date submitted for ethics approval [1] 288607 0
Approval date [1] 288607 0
17/05/2012
Ethics approval number [1] 288607 0
H9540

Summary
Brief summary
It is thought that any type of exercise is sufficient for the treatment of chronic low back pain. There is a paucity of evidence examining a rigorous individualization approach to exercise prescription for low back pain patients. This study will compare changes in pain and disability between individualized or general exercise advice for patients with chronic low back pain. The hypothesis of this research is that individualized programming will elicit greater reductions in pain and disability. Data from this study will be used for power calculations in a larger scale trial that will explore the 'why' of observed results.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 36926 0
Dr Paul Marshall
Address 36926 0
University of Western Sydney

Locked Bag 1797 Penrith South
NSW 2751
Australia
Country 36926 0
Australia
Phone 36926 0
+61 2 4620 3915
Fax 36926 0
Email 36926 0
p.marshall@uws.edu.au
Contact person for public queries
Name 36927 0
Dr Paul Marshall
Address 36927 0
University of Western Sydney

Locked Bag 1797 Penrith South
NSW 2751
Australia
Country 36927 0
Australia
Phone 36927 0
+61 2 4620 3915
Fax 36927 0
Email 36927 0
p.marshall@uws.edu.au
Contact person for scientific queries
Name 36928 0
Dr Paul Marshall
Address 36928 0
University of Western Sydney

Locked Bag 1797 Penrith South
NSW 2751
Australia
Country 36928 0
Australia
Phone 36928 0
+61 2 4620 3915
Fax 36928 0
Email 36928 0
p.marshall@uws.edu.au

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.