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Trial registered on ANZCTR


Trial ID
ACTRN12605000039684
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
25/07/2005
Date last updated
9/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise or advice for subacute low back pain
Scientific title
Randomized controlled trial comparing the efficacy of exercise, advice or both for sub-acute low back pain
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacute (ie duration 6 weeks to 3 months) non-specific low back pain 105 0
Condition category
Condition code
Other 124 124 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12 exercise or sham exercise sessions were delivered over 6 weeks: three sessions per week in weeks 1 and 2, two sessions per week in weeks 3 and 4 and one session per week in weeks 5 and 6. On three separate occasions in weeks 1, 2 and 4, participants also received advice or sham advice.
The exercise program was an individualized, progressive, submaximal program designed to improve participants ability to complete functional activities specified by the participant as being difficult because of low back pain. Advice sessions were based on the advice given by Indahl et al. and aimed to encourage a graded return to normal activities. The therapist explained the benign nature of low back pain, addressed any unhelpful beliefs about back pain and emphasized that being overly careful and avoiding light activity would delay recovery.During sham advice sessions, participants were given the opportunity to talk about their low back pain and any other problems that they were having. The therapist responded in a warm and empathic manner, displaying genuine interest in the participant, but did not give advice about the low back pain.
Intervention code [1] 1947 0
Rehabilitation
Comparator / control treatment
The control for exercise intervention consisted of detuned ultrasound therapy (5 minutes) and detuned short-wave diathermy (20 minutes).
Control group
Placebo

Outcomes
Primary outcome [1] 154 0
Pain
Timepoint [1] 154 0
At 6 weeks and 12 months
Primary outcome [2] 155 0
Global perceived effect
Timepoint [2] 155 0
At 6 weeks and 12 months
Primary outcome [3] 156 0
Functional ability
Timepoint [3] 156 0
At 6 weeks and 12 months
Secondary outcome [1] 341 0
Global perceived effect and functional ability
Timepoint [1] 341 0
At 3 months
Secondary outcome [2] 342 0
Number of health care contacts
Timepoint [2] 342 0
In the past 6 weeks at 12 months
Secondary outcome [3] 343 0
Disability
Timepoint [3] 343 0
At 6 weeks, 3 and 12 months.
Secondary outcome [4] 344 0
Depression
Timepoint [4] 344 0
At 6 weeks, 3 and 12 months.
Secondary outcome [5] 5377 0
Pain
Timepoint [5] 5377 0
3 months

Eligibility
Key inclusion criteria
Non-specific low back pain of at least 6 weeks but less than 3 months duration.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Spinal surgery in the past 12 months, pregnancy, specific spinal pathology, contra-indications to exercise, or poor English comprehension.

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)
The allocation schedule was generated by a person not involved in the trial and placed in sequentially numbered, sealed, opaque envelopes. At each site the trial coordinator or the physical therapist allocated participants to groups by opening the next-numbered envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule was generated using the random number function in excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment outside Australia
Country [1] 130 0
New Zealand
State/province [1] 130 0
Auckland

Funding & Sponsors
Funding source category [1] 2486 0
Government body
Name [1] 2486 0
NHMRC
Address [1] 2486 0
Canberra
Country [1] 2486 0
Australia
Funding source category [2] 2487 0
Other
Name [2] 2487 0
Australasian Low Back Pain Trial Consortium
Address [2] 2487 0
Melbourne
Country [2] 2487 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Lidcombe NSW
Country
Australia
Secondary sponsor category [1] 123 0
None
Name [1] 123 0
Nil
Address [1] 123 0
Country [1] 123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4394 0
University of Sydney
Ethics committee address [1] 4394 0
Ethics committee country [1] 4394 0
Australia
Date submitted for ethics approval [1] 4394 0
Approval date [1] 4394 0
Ethics approval number [1] 4394 0
Ethics committee name [2] 4395 0
Bankstown Hospital
Ethics committee address [2] 4395 0
Ethics committee country [2] 4395 0
Australia
Date submitted for ethics approval [2] 4395 0
Approval date [2] 4395 0
Ethics approval number [2] 4395 0
Ethics committee name [3] 4396 0
Royal Prince Alfred Hospital
Ethics committee address [3] 4396 0
Ethics committee country [3] 4396 0
Australia
Date submitted for ethics approval [3] 4396 0
Approval date [3] 4396 0
Ethics approval number [3] 4396 0
Ethics committee name [4] 4397 0
St George Hospital
Ethics committee address [4] 4397 0
Ethics committee country [4] 4397 0
Australia
Date submitted for ethics approval [4] 4397 0
Approval date [4] 4397 0
Ethics approval number [4] 4397 0
Ethics committee name [5] 4398 0
Royal North Shore Hospital
Ethics committee address [5] 4398 0
Ethics committee country [5] 4398 0
Australia
Date submitted for ethics approval [5] 4398 0
Approval date [5] 4398 0
Ethics approval number [5] 4398 0
Ethics committee name [6] 4399 0
Auckland University of Technology
Ethics committee address [6] 4399 0
Ethics committee country [6] 4399 0
New Zealand
Date submitted for ethics approval [6] 4399 0
Approval date [6] 4399 0
Ethics approval number [6] 4399 0
Ethics committee name [7] 4400 0
Middlemore Hospital Auckland
Ethics committee address [7] 4400 0
Ethics committee country [7] 4400 0
New Zealand
Date submitted for ethics approval [7] 4400 0
Approval date [7] 4400 0
Ethics approval number [7] 4400 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Pengel L, Refshauge K, Maher CG, Nicholas M, Herbert RD, McNair P. Physiotherapist-directed exercise, advice or both for subacute low back pain: a randomised controlled trial. Annals of Internal Medicine 2007 146: 787-796.
Public notes

Contacts
Principal investigator
Name 35750 0
Address 35750 0
Country 35750 0
Phone 35750 0
Fax 35750 0
Email 35750 0
Contact person for public queries
Name 9248 0
A/Prof Chris Maher
Address 9248 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 9248 0
Australia
Phone 9248 0
+61 2 93519192
Fax 9248 0
+61 2 93519601
Email 9248 0
C.Maher@usyd.edu.au
Contact person for scientific queries
Name 176 0
A/Prof Chris Maher
Address 176 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 176 0
Australia
Phone 176 0
+61 2 93519192
Fax 176 0
+61 2 93519601
Email 176 0
C.Maher@usyd.edu.au