Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000085673
Ethics application status
Approved
Date submitted
15/01/2014
Date registered
23/01/2014
Date last updated
23/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does targeted management of sub-acute back pain patients on a surgical clinic waiting list reduce chronic pain and disability? Phase 1: Risk screening.
Scientific title
Risk-screening questionnaires provided to sub-acute back pain patients on a surgical clinic waiting list: does screening itself reduce chronic pain and disability?
Secondary ID [1] 283909 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back pain 290982 0
Condition category
Condition code
Musculoskeletal 291259 291259 0 0
Other muscular and skeletal disorders
Public Health 291327 291327 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be initiallly contacted by telephone and will subsequently receive 3 questionnaires via mail to complete and return. These questionnaires aim to screen for risk of developing chronic pain and disability and will be evaluated for their usefulness in this patient group. Follow-up will occur after 4 months. Two of these questionnaires have been previously validated: (i) The Orebro Musculoskeltal Pain Screening Questionnaire (short version) and (ii) The STarT Back Screening Tool. The third screening tool - The 3 Item Screening Questionnaire, has been specifically developed for this study. All questionnaires are sent together at the initial timepoint.
Intervention code [1] 288589 0
Early detection / Screening
Comparator / control treatment
Participants in the control group will not receive any screening questionnaires. They will be evaluated at the 4 month timepoint.
Control group
Active

Outcomes
Primary outcome [1] 291255 0
Pain Numeric Rating Scale score
Timepoint [1] 291255 0
At 4 month follow up
Primary outcome [2] 291256 0
Disability Numeric Rating Scale score
Timepoint [2] 291256 0
At 4 month follow-up
Secondary outcome [1] 306352 0
Roland Morris Disability Questionnaire
Timepoint [1] 306352 0
4 month follow-up
Secondary outcome [2] 306353 0
Pain Catastrophising Scale
Timepoint [2] 306353 0
4 month follow-up
Secondary outcome [3] 306354 0
Hospital Anxiety and Depression Score
Timepoint [3] 306354 0
4 month follow-up
Secondary outcome [4] 306355 0
Pain-Self-Efficacy Questionnaire
Timepoint [4] 306355 0
4 month follow-up

Eligibility
Key inclusion criteria
Patients with sub-acute lumbar spine disorders who have been referred to the RAH Orthopaedic Spinal Outpatients, triaged (from documented referral information) and placed on a Spinal Outpatient Clinic waiting list.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to speack and understand English (interpreter requested in referral)
- Previous lumbar spine surgery reported in referral

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After satisfying the selection criteria (assessed from referral information provided) participants will be randomly assigned to the screening group or the control group. This will be achieved through central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of participants will occur using a computer software generated randomisation table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based upon published variance measures for the primay outcome variables: 11 point (0-10) numerical rating scales for pain and disability. The pain measure shows the higher variance - the mean (SD) pain score for patients with subacute low back pain is 5.3 (2.2) and the limiting factor will be the comparison of those patients who are screened and those who are not. As such, in order to detect a 2 point difference between these groups and obtain likelihood ratios with acceptable confidence intervals, with an alpha of 0.005 and 80% power, we will need 196 patients.
The research team will continue to work with a biostatistician to formulate and analysis framework as the project progresses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2014
Actual
Date of last participant enrolment
Anticipated
5/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1968 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7700 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288549 0
Hospital
Name [1] 288549 0
Royal Adelaide Hospital
Country [1] 288549 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 287261 0
University
Name [1] 287261 0
University of South Australia
Address [1] 287261 0
GPO Box 2471, Adelaide, SA, 5000
Country [1] 287261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290413 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 290413 0
North Terrace, Adelaide, SA, 5000
Ethics committee country [1] 290413 0
Australia
Date submitted for ethics approval [1] 290413 0
Approval date [1] 290413 0
09/12/2013
Ethics approval number [1] 290413 0
131202

Summary
Brief summary
This investigation involves the collection of data via postal questionnaires from patients with low back pain who have been placed on a waiting list for surgical opinion. The questionnaires aim to identify those at risk of developing chronic back pain and will be evaluated for their usefulness in this patient group. Additionally, this study will ask the question of whether screening itself reduces pain and disability. This investigation will lay the critical platform for an investigation of treatment aimed at reducing risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45566 0
Mrs Emma Karran
Address 45566 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 45566 0
Australia
Phone 45566 0
61 8 82225334
Fax 45566 0
Email 45566 0
[email protected]
Contact person for public queries
Name 45567 0
Mrs Emma Karran
Address 45567 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 45567 0
Australia
Phone 45567 0
61 8 82225334
Fax 45567 0
Email 45567 0
[email protected]
Contact person for scientific queries
Name 45568 0
Mrs Emma Karran
Address 45568 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 45568 0
Australia
Phone 45568 0
61 8 82225334
Fax 45568 0
Email 45568 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.