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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:
001162
ACTR Number:
ACTRN12606000098538
Trial Status:
Registered
Date Submitted:
11/03/2006
Date Registered:
14/03/2006
Page 1
Public title:
The management of acute low-back pain in general practice
Update:
Reason:
ANZCTR registration title:
Implementing a clinical practice guideline for acute low-back pain evidence-based management in general practice: a cluster randomised controlled trial of the effectiveness of a tailored implementation strategy on patient low-back pain disability and x-ray referral
Update:
Reason:
Secondary ID:
UTN:
Update:
Reason:
Trial acronym:
IMPLEMENT
Update:
Page 2
Health condition(s) or problem(s) studied:
Acute (duration <3 months) non-specific low-back pain
Condition category:
Condition code:
Musculoskeletal
Pain management
Page 3
Description of intervention(s) / exposure:
Intervention: tailored implementation strategy (face-to-face education sessions, printed educational materials and patient education) for a clinical practice guideline. Delivered over a two month time period.
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Reason:
Intervention code:
None
Comparator / control treatment:
Control: dissemination only of the clinical practice guideline. Delivered at a single time point.
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Reason:
Control group:
Active
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Reason:
Page 4
Primary outcome 1:
General practitioner level: X-ray referral within a three month period post patient enrolment.
Timepoint:
Within a 3 month period post patient enrolment.
Primary outcome 2:
Patient level: low-back pain specific disability.
Timepoint:
3 months from enrolment
Secondary outcome 1:
General practitioner (GP) level #1: measurement of behavioural constructs. Measured by reliable and valid questionnaire.
Timepoint:
baseline and 12 months
Secondary outcome 2:
GP level #2: GPs fear-avoidance beliefs. Measured by reliable and valid questionnaire.
Timepoint:
baseline and 12 months
Secondary outcome 3:
GP level #3: whether or not the GP provided advice on activity or bed-rest. Measured via patient interview.
Timepoint:
seven days post-consultation with LBP patient
Secondary outcome 4:
GP level #4: referral for any type of imaging. Measured via patient interview.
Timepoint:
Three months post-consultation
Secondary outcome 5:
Patient level #1: Pain at rest. Self-reported measure on scale of 0 to 10.
Timepoint:
7 days and 3 months after consultation
Secondary outcome 6:
Patient level #2: whether the patient received an x-ray. Measured by patient interview.
Timepoint:
7 days and 3 months after consultation
Secondary outcome 7:
Patient level #3: quality of life. Measured by patient interview.
Timepoint:
7 days and 3 months after consultation
Secondary outcome 8:
Patient level #4: health service utilisation. Measured by patient interview.
Timepoint:
7 days and 3 months after consultation
Page 5
Key inclusion criteria:
General practices will be included if:1. The practice manager agrees to the practice being involved in the C-RCT.2. At least one GP, and no objection from the remaining GPs, within the practice provide written informed consent.3. Practice GPs do not work in more than one practice.4. Practice support staff are willing to facilitate patient recruitment. Patients will be included if:1. They attend the participating practices for acute non-specific LBP (duration of less than three months).2. Provide written informed consent.3. Are able to write and understand English.
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Reason:
Minimum Age:
18
Years
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Reason:
Maximum Age:
Not stated
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Gender:
Both males and females
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Reason:
Healthy volunteers?
No
Update:
Reason:
Key exclusion criteria:
General practices will be excluded if:1. Any of the GPs at the practice participated in focus groups during part one of this study.Patients will be excluded if:1. Radicular pain is present.2. They have had previous spinal surgery.3. “Red flags” are present, alerting the possibility of serious conditions such as malignancy, infection and fracture.4. Pregnancy.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Educational / counselling / training
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Allocation to intervention:
Randomised controlled trial
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Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
A statistician independent of the study and located at a central administration location will implement the randomisation. Allocation will involve contacting the statistician via phone/email and providing them only with general practice codes and strata variables which will be used in the randomisation. The statistician will then provide the allocation of the general practices.
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Restricted randomisation will be employed. Computer generated random numbers will be used to randomly select permutations.
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Reason:
Masking / blinding:
Blinded (masking used)
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Who is/are masked/blinded:
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
Update:
Reason:
Anticipated or actual date of first participant enrolement:
1/06/2006
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Reason:
Target sample size:
2300
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Reason:
Recruitment status:
Open to recruitment
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Reason:
Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
NHMRC,Primary Health Care Project Grant 334060
Address:
Level 5, 20 Allara Street
Canberra ACT 2601
Country:
Australia
Primary sponsor:
University
Update:
Reason:
Name:
Institute of Health Services Research, Monash University
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Reason:
Address:
43-51 Kanooka Grove
Clayton, VIC 3168
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Reason:
Country:
Australia
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Reason:
Secondary sponsor:
University
Name:
Department of General Practice, Monash University
Address:
Building 1, Omnico Business Park
270 Ferntree Gully Rd
Notting Hill VIC 3168
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Monash University Standing Committee on Ethics in Research Involving Humans
Address:
Country:
Australia
Date of approval:
HREC Number:
2006/047
Countries of recruitment:
Australia
Brief summary:
The recently released NHMRC-endorsed evidence-based clinical practice guideline for acute low-back pain management provides an opportunity to assess the effects of a tailored implementation strategy for use in general medical practice. This trial will assess the effectiveness of the implementation strategy both at the general practitioner and patient level and also assess the cost effectiveness of the strategy. Successful implementation of these guidelines will reduce the morbidity and cost of acute low-back pain. The trial will contribute to our knowledge about implementation strategies attempting to change clinical practice behaviour.
Update:
Reason:
Trial website:
http://www.cochrane.org.au/projects/implement.php
Update:
Presentations / publication list:
McKenzie J, French S, O'Connor D, Grimshaw J, Mortimer D, Michie S, Francis F, Spike N, Schattner P, Kent P, Buchbinder R & Green S (2008). IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): cluster randomised controlled trial study protocol. Implementation Science 3: 11.
http://www.implementationscience.com/content/3/1/11
Mortimer D, French S, McKenzie J, O'Connor D & Green S (2008). Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial. Implementation Science 3: 12
http://www.implementationscience.com/content/3/1/12
Update:
Page 10
Contact person for public queries
Name:
Simon French
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Reason:
Address:
Australasian Cochrane Centre Monash Institute of Health Services Research 43 - 51 Kanooka Grove Locked Bag 29 Clayton VIC 3168
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Reason:
Country:
Australia
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Tel:
+61 3 95947526
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Fax:
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Email:
simon.french@med.monash.edu.au
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Contact person for scientific queries
Name:
Sally Green
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Reason:
Address:
Australasian Cochrane Centre Monash Institute of Health Services Research 43 - 51 Kanooka Grove Locked Bag 29 Clayton VIC 3168
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Reason:
Country:
Australia
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Tel:
+61 3 95947531
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Fax:
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Email:
Sally.Green@med.monash.edu.au
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