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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000066
ACTR Number: ACTRN12605000039684
Trial Status: Registered
Date Submitted: 25/07/2005
Date Registered: 25/07/2005

Page 1

Public title: Exercise or advice for subacute low back pain
ANZCTR registration title: Randomized controlled trial comparing the efficacy of exercise, advice or both for sub-acute low back pain
Secondary ID: 
UTN:
Trial acronym: Nil

Page 2

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

Page 3

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: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

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Primary outcome 1:Pain 
Timepoint:At 6 weeks and 12 months 
Primary outcome 2:Global perceived effect 
Timepoint:At 6 weeks and 12 months 
Primary outcome 3:Functional ability 
Timepoint:At 6 weeks and 12 months 
Secondary outcome 1:Global perceived effect and functional ability 
Timepoint:At 3 months 
Secondary outcome 2:Number of health care contacts 
Timepoint:In the past 6 weeks at 12 months 
Secondary outcome 3:Disability 
Timepoint:At 6 weeks, 3 and 12 months. 
Secondary outcome 4:Depression 
Timepoint:At 6 weeks, 3 and 12 months. 
Secondary outcome 5:Pain 
Timepoint:3 months 

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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
Healthy volunteers? No
Key exclusion criteria: Spinal surgery in the past 12 months, pregnancy, specific spinal pathology, contra-indications to exercise, or poor English comprehension.

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the 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.
Describe the 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:
Assignment: Factorial
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 3
Anticipated or actual start date: 1/01/2001
Target sample size: 260
Recruitment status: Completed

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Funding source 1:Government funding body e.g. Australian Research Council 
Name:NHMRC 
Address:Canberra 
Country:Australia 
Funding source 2:Other 
Name:Australasian Low Back Pain Trial Consortium 
Address:Melbourne 
Country:Australia 
Primary sponsor: University
Name: University of Sydney
Address: Lidcombe NSW
Country: Australia
Secondary sponsor:None 
Name:Nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:University of Sydney 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Bankstown Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:Royal Prince Alfred Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 4:St George Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 5:Royal North Shore Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:Auckland University of Technology 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 7:Middlemore Hospital Auckland 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Postcode:Outside Australia 
New Zealand - Auckland 
Brief summary:
Trial website:
Presentations / publication list: 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.

Page 10

Contact person for public queries
Name: A/Prof Chris Maher
Address: School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country: Australia
Tel: +61 2 93519192
Fax: +61 2 93519601
Email: C.Maher@usyd.edu.au

Contact person for scientific queries
Name: A/Prof Chris Maher
Address: School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country: Australia
Tel: +61 2 93519192
Fax: +61 2 93519601
Email: C.Maher@usyd.edu.au

Contact person responsible for updating information
Name: A/Prof Chris Maher
Address: School of Physiotherapy Faculty of Health Sciences University of Sydney PO Box 170 Lidcombe NSW 1825
Country: Australia
Tel: 61 2 93519192
Fax: 61 2 93519601
Email: C.Maher@usyd.edu.au
   
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