Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Fourth Floor
Ministry of Health Buildings
229 Moray Place
Dunedin 9016
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
Low back Pain is by far the most prevalent and most costly musculoskeletal problem in our society today. Our study aims to define outcome assessment tools of patients with acute low back pain and patient characteristics which allow the identification of patients at risk to develop chronic low back pain and at which point in time chronification becomes manifest.
In this study, patients will be recruited from GP clinics in New Zealand and Switzerland. Participants will be assessed directly after attending their GP for acute back pain treatment and at different points of follow-up. Outcome assessment tools will cover disability, pain, physical and mental health. All of these tools are frequently used in outcome assessment of low back pain.
This study will develop a set of outcome assessment tools for patients with acute low back pain in GP clinics showing if these patients are at risk to develop chronic low back pain. In addition, psychosocial and occupational patient characteristics will be identified which influence the course from acute to chronic low back pain. Furthermore, an appropriate point in time for follow-ups will be given to detect this transition. The international perspective of this study of patients in New Zealand and Switzerland will be an asset in terms of generalizability of our findings.
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
[email protected]
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
[email protected]

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.