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Key inclusion criteria:
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Non-specific low back pain of at least 6 weeks but less than 3 months duration. |
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Reason:
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Minimum Age:
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18
Years
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Update:
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Reason:
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Maximum Age:
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80
Years
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Reason:
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Gender:
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Both males and females |
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Reason:
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Healthy volunteers?
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No |
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Reason:
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Key exclusion criteria:
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Spinal surgery in the past 12 months, pregnancy, specific spinal pathology, contra-indications to exercise, or poor English comprehension. |
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Reason:
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Page 6
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Study type: |
Interventional |
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Reason:
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Purpose of the study: |
Treatment |
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Allocation to intervention: |
Randomised controlled trial |
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Reason:
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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. |
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Reason:
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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 |
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Reason:
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Masking / blinding: |
Blinded (masking used) |
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Reason:
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Who is/are masked/blinded: |
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Update:
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Reason:
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Assignment: |
Factorial |
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Reason:
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Other design features (specify): |
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Update:
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Reason:
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Type of endpoint(s): |
Efficacy |
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Reason:
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Update:
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Reason:
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Update:
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Reason:
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Update:
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Reason:
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Update:
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Reason:
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Page 7
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Phase |
Phase 3 |
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Reason:
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Anticipated or actual start date: |
1/01/2001 |
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Reason:
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Target sample size: |
260 |
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Reason:
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Recruitment status: |
Completed |
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Reason:
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Page 8
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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 |
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Primary sponsor: |
University |
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Reason:
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Name: |
University of Sydney |
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Reason:
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Address: |
Lidcombe NSW |
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Update:
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Reason:
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| Country:
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Australia |
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Update:
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Reason:
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| Secondary sponsor: | None |
| Name: | Nil |
| Address: | |
| Country: | |
| Other collaborator: | |
Page 9
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Has the study received approval from at least one ethics committee? |
Yes |
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Update:
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Reason:
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| 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 |
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Brief summary: |
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Update:
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Reason:
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Trial website: |
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Update:
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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. |
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Page 10
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Contact person for public queries
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Name: |
A/Prof Chris Maher |
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Reason:
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Address: |
School of Physiotherapy Faculty of Health Sciences University of Sydney PO Box 170 Lidcombe NSW 1825 |
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Reason:
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Country: |
Australia |
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Update:
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Reason:
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Tel: |
+61 2 93519192 |
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Update:
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Reason:
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Fax: |
+61 2 93519601 |
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Update:
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Reason:
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Email: |
C.Maher@usyd.edu.au |
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Update:
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Reason:
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Contact person for scientific queries |
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Name: |
A/Prof Chris Maher |
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Update:
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Reason:
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Address: |
School of Physiotherapy Faculty of Health Sciences University of Sydney PO Box 170 Lidcombe NSW 1825 |
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Update:
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Reason:
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Country: |
Australia |
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Update:
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Reason:
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Tel: |
+61 2 93519192 |
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Update:
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Reason:
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Fax: |
+61 2 93519601 |
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Update:
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Reason:
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Email: |
C.Maher@usyd.edu.au |
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Update:
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Reason:
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Contact person responsible for updating information |
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Name: |
A/Prof Chris Maher |
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Update:
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Reason:
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Address: |
School of Physiotherapy Faculty of Health Sciences University of Sydney PO Box 170 Lidcombe NSW 1825 |
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Update:
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Reason:
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Country: |
Australia |
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Update:
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Reason:
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Tel: |
61 2 93519192 |
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Update:
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Reason:
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Fax: |
61 2 93519601 |
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Update:
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Reason:
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Email: |
C.Maher@usyd.edu.au |
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Update:
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Reason:
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