Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000520336
Ethics application status
Approved
Date submitted
29/09/2008
Date registered
9/10/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Dunedin Acute Back Pain Study: Identifying patients at risk to develop chronic low back pain
Scientific title
Predicting the transition from acute to chronic low back pain: Development of a screening tool for patients with acute low back pain in a general practitioner (GP) setting
Secondary ID [1] 253460 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute low back pain 3769 0
Condition category
Condition code
Musculoskeletal 3944 3944 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study on the course of acute low back pain over the time of 6 months. Postal survey of patients with acute back pain - after attending a GP clinic with low back pain for the first time or with a new episode after a pain free period of at least 6 months - assessing biomedical, psychological, social, and occupational factors at 4 points of follow-up (3, 6, 12 weeks and 6 months).
Intervention code [1] 3481 0
Not applicable
Comparator / control treatment
Observational study with one single cohort
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4842 0
Condition-specific disability as measured by the Oswestry Disability Index (ODI) in % between 0 and 100 with an ODI of 100% being the highest disability
Timepoint [1] 4842 0
At baseline and at 3, 6, 12 weeks and 6 months follow-up
Secondary outcome [1] 8182 0
Pain as measured by the Visual Analogue Scale VAS
Timepoint [1] 8182 0
At baseline and at 3, 6, 12 weeks and 6 months follow-up
Secondary outcome [2] 8183 0
General health as measured by the SF-12
Timepoint [2] 8183 0
At baseline and at 3, 6, 12 weeks and 6 months follow-up
Secondary outcome [3] 8269 0
Screening tool including biomedical, psychological, social, and occupational factors predicting the development of chronic low back pain. In addition to ODI, VAS, and SF-12 the following assessment instruments/questions will be used at baseline, 3, 6, 12 weeks and 6 months follow-up:
-SF-McGill (pain rating and overall pain intensity)
-Deyo core measures (reduction in normal activities due to low back pain; patient satisfaction with condition and care; sick leave)
-Medication (use of analgesics and non-steroidal anti-inflammatory drugs)
-Modified depression index by Zung
-Modified Somatic Perception Questionnaire (MSPQ)
-Fear-Avoidance Beliefs Questionnaire (FABQ)
-Pain Catastrophizing Scale (PCS)
-Return to work according to the World Health Organization (WHO) Health Survey
Timepoint [3] 8269 0
At baseline and at 3, 6, 12 weeks and 6 months follow-up

Eligibility
Key inclusion criteria
Patients attending GP clinic with acute low back pain; good understanding of English/German
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic low back pain; specific low back pain; comorbidity determining overall well-being; pregnancy; expected loss to follow-up; unwillingness to complete questionnaires

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 1241 0
Switzerland
State/province [1] 1241 0
Country [2] 1242 0
New Zealand
State/province [2] 1242 0

Funding & Sponsors
Funding source category [1] 3943 0
Commercial sector/Industry
Name [1] 3943 0
realHealth International AG
Country [1] 3943 0
Switzerland
Funding source category [2] 3944 0
Charities/Societies/Foundations
Name [2] 3944 0
The Wishbone Trust New Zealand
Country [2] 3944 0
New Zealand
Funding source category [3] 3945 0
University
Name [3] 3945 0
Dunedin School of Medicine
University of Otago
Country [3] 3945 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Orthopaedic Surgery
Dunedin Hospital
Private Bag 1921
Dunedin 9001
Country
New Zealand
Secondary sponsor category [1] 3537 0
Charities/Societies/Foundations
Name [1] 3537 0
South Link Health Inc
Address [1] 3537 0
Level 9
10 George Street
PO Box 6032
Dunedin 9016
Country [1] 3537 0
New Zealand
Other collaborator category [1] 436 0
Hospital
Name [1] 436 0
Swiss Paraplegic Centre
Address [1] 436 0
Department of Surgery and Orthopaedics
Swiss Paraplegic Centre
Guido A. Zaech-Strasse 1
6207 Nottwil
Country [1] 436 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6009 0
Lower South Regional Ethics Committee
Ethics committee address [1] 6009 0
Ethics committee country [1] 6009 0
New Zealand
Date submitted for ethics approval [1] 6009 0
Approval date [1] 6009 0
10/04/2008
Ethics approval number [1] 6009 0
LRS/08/03/008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28987 0
Address 28987 0
Country 28987 0
Phone 28987 0
Fax 28987 0
Email 28987 0
Contact person for public queries
Name 12144 0
Dr Markus Melloh
Address 12144 0
Department of Orthopaedic Surgery
Dunedin Hospital
Private Bag 1921
Dunedin 9001
Country 12144 0
New Zealand
Phone 12144 0
+64 3 474 7007 ext 8609
Fax 12144 0
Email 12144 0
markus.melloh@otago.ac.nz
Contact person for scientific queries
Name 3072 0
Dr Markus Melloh
Address 3072 0
Department of Orthopaedic Surgery
Dunedin Hospital
Private Bag 1921
Dunedin 9001
Country 3072 0
New Zealand
Phone 3072 0
+64 3 474 7007 ext 8609
Fax 3072 0
Email 3072 0
markus.melloh@otago.ac.nz

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
No additional documents have been identified.