Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000432415
Ethics application status
Approved
Date submitted
15/08/2007
Date registered
24/08/2007
Date last updated
24/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Which exercise for chronic low back pain?
Scientific title
A comparison of the effects of motor control exercises and graded activity on pain and disability in subjects with chronic non specific low back pain.
Secondary ID [1] 461 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 2267 0
Condition category
Condition code
Musculoskeletal 2358 2358 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pragmatic randomised controlled trial with 172 subjects randomised to two treatment groups (i) motor control exercise (ii) graded activity. Both treatments will consist of 12 one hour treatments over an 8 week period, ie: 2 sessions/week in the first month and 1 session/week in the second month and 2 additional 1 hour follow-up sessions at 4 & 10 months. Patients will be advised to do home exercises, consistent with the exercise approach they are receiving. The total time for home exercises will sum to at least 1/2 hour/week in the first month and 1 hr/week in the second month. The treatment sessions and home exercises will add up to at least 20 hours of treatment.
Intervention code [1] 1978 0
Rehabilitation
Comparator / control treatment
The trial compares two active treatments.
Control group
Active

Outcomes
Primary outcome [1] 3256 0
Function measured with the Patient-specific functional scale
Timepoint [1] 3256 0
2 and 6 months
Primary outcome [2] 3257 0
"Average pain intensity over the last week" measured on a 0-10 scale
Timepoint [2] 3257 0
2 and 6 months
Secondary outcome [1] 5430 0
Condition-specific measure of disability (Roland Morris Disability Questionnaire)
Timepoint [1] 5430 0
2, 6 and 12 months
Secondary outcome [2] 5431 0
Generic measure of health status (SF 36)
Timepoint [2] 5431 0
2, 6 and 12 months
Secondary outcome [3] 5432 0
"Average pain intensity over the preceding 24 hours" measured on a 0-10 scale
Timepoint [3] 5432 0
Monthly for 1-12 months
Secondary outcome [4] 5433 0
"Average pain intensity over the preceding week" measured on a 0-10 scale
Timepoint [4] 5433 0
Monthly for 1-12 months
Secondary outcome [5] 5434 0
Function measured with the Patient-specific functional scale
Timepoint [5] 5434 0
12 months
Secondary outcome [6] 5435 0
Patient's global impression of change (Global Perceived Effect)
Timepoint [6] 5435 0
2, 6 and 12 months

Eligibility
Key inclusion criteria
Non specific low back pain +/- leg pain persisting for at least 3 months.
Currently seeking treatment for low back pain.
Clinical assessment indicates that the subject is suitable for active exercises.
At least "moderate" on item 7 or 8 of the SF 36.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology.
Nerve root compromise.
Previous spinal surgery or scheduled for major surgery during the treatment or follow-up period.
Co-morbid health conditions that would prevent active participation in exercise programs.

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)
Subjects seeking treatment for their low back pain will be approached by medical practitioners and physiotherapists. If the subject demonstrates interest in participating in the study the recruiting primary care practitioner will contact the investigators who will screen the subjects for eligibility criteria and obtain consent. Randomisation will be performed at the first treatment session by the physiotherapist. Numbered, sealed, opaque envelopes will be used to conceal the patient's group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be generated using the random number function in Excel. We will generate a sequence with random permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 223 0
2148

Funding & Sponsors
Funding source category [1] 2516 0
Government body
Name [1] 2516 0
National Health and Medical Research Council (NHMRC)
Country [1] 2516 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Facutly of Health Sciences
PO Box 170
Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 2280 0
University
Name [1] 2280 0
The University of Queensland
Address [1] 2280 0
School of Health and Rehabilitation Sciences,
The University of Queensland,
Brisbane, QLD, 4072
Country [1] 2280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4430 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 4430 0
Room L4.13
Main Quadrangle - A14
The University of Sydney
NSW 2006
Ethics committee country [1] 4430 0
Australia
Date submitted for ethics approval [1] 4430 0
Approval date [1] 4430 0
18/12/2006
Ethics approval number [1] 4430 0
12-2006/9704

Summary
Brief summary
About 1 in 10 Australians have persisting or chronic low back pain. Most are managed in primary care and the most frequently prescribed treatment is exercise. Chronic low back pain remains a major health problem because not all patients respond to each treatment so on average treatment effects are small. At present there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money is wasted on treatments which ultimately fail to help the patient.

Our proposed study is a direct comparison of the two most promising types of exercise approaches used in Australia: a graded activity program where patients perform an individualised, whole body exercise program, and a motor control program, where patients perform a series of specific spinal stabilisation exercises. This study will compare the effects of these two interventions. We will also identify patient features that may predict a patient's response to treatment. Prediction features used will be clinical/demographic data, measures of beliefs and attitudes about pain, measures of physical activity and fitness, measures of control and co-ordination of the lumbar spine and pelvis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27988 0
Address 27988 0
Country 27988 0
Phone 27988 0
Fax 27988 0
Email 27988 0
Contact person for public queries
Name 11145 0
Luciana Macedo
Address 11145 0
Discipline of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney
PO Box 170
Lidcombe 1825
Country 11145 0
Australia
Phone 11145 0
+61 2 9351 9952
Fax 11145 0
+61 2 9351 9681
Email 11145 0
[email protected]
Contact person for scientific queries
Name 2073 0
Dr Jane Latimer
Address 2073 0
Discipline of Physiotherapy,
Faculty of Health Sciences,
The University of Sydney
PO Box 170
Lidcombe 1825
Country 2073 0
Australia
Phone 2073 0
+61 2 9351 9191
Fax 2073 0
+61 2 9351 9601
Email 2073 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
SourceTitleYear of PublicationDOI
EmbasePredicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial.2014https://dx.doi.org/10.2522/ptj.20140014
Dimensions AIMotor control or graded activity exercises for chronic low back pain? A randomised controlled trial2008https://doi.org/10.1186/1471-2474-9-65
N.B. These documents automatically identified may not have been verified by the study sponsor.