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Trial registered on ANZCTR


Registration number
ACTRN12614000830695
Ethics application status
Not yet submitted
Date submitted
15/07/2014
Date registered
5/08/2014
Date last updated
5/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient led goal setting in chronic low back pain
Scientific title
Is patient led goal setting more effective than usual care in improving disability and pain in chronic low back pain?
Secondary ID [1] 284994 0
nil known
Universal Trial Number (UTN)
U1111-1159-3467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 292499 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292810 292810 0 0
Physiotherapy
Musculoskeletal 292964 292964 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient led goal setting- participants will be facilitated by a physiotherapist to determine problems areas, goals and strategies relevant to their low back pain.
Patient led goal setting sessions will be delivered as individual face to face consultations, a total of 8 times: 5 sessions during the first 2 months (one at baseline and 4 sessions at fortnightly intervals) followed by 2 sessions at 1-month intervals. There will be a final session at the 12-month follow-up.Together with the RA, participants randomized to the patient led goal setting group will identify the problems that are most important to them, practical strategies to address each of these problems, and specify desired outcomes. Participants will be given a participant workbook in which they will record their identified issues, and the priority assigned to each. They will record their target goals and the strategies to achieve them, including each step and the timeframe. The workbook will also contain some basic physiology relevant to chronic low back pain, common treatments for symptom control and goal setting guidelines written in simple language. At the conclusion of each visit, the workbook will be copied to enable analysis of the goals and any new identified strategies.
The first session: the first session will commence with participants discussing those aspects of their back pain or related health issues that are of greatest personal concern to them. A stimulus list of all prognostic factors (e.g. depression or low mood, lack of physical activity, fear of activity, weight loss, etc) may be used when required. Once identified, participants will prioritise their concerns and the first two will initially be selected for goal-setting. Participants will learn how to transform these concerns into goals, formulate strategies to attain these goals and learn how to set realistic steps. Use of evidence-based or best practice management for each goal will be encouraged. The participant will be asked to carry out the set strategies between sessions.
Subsequent visits: The participant and the therapist will review the agreed goals and strategies, and the extent of achievement. Working together, they will determine the need for modification to the goals set, strategies and time frames.
The final visit: The therapeutic interaction will conclude at the final visit. The process, strategies undertaken during the intervention period and any other concerns of the participant will be reviewed. Together, the participant and therapist will plan ongoing self-management and review how to make decisions about seeking future health care and possible referral to their primary care practitioner.

Intervention code [1] 289830 0
Rehabilitation
Comparator / control treatment
Usual care- the intervention group will be compared to a control group who will undertake their usual care with their treating primary care health professional.
Usual care will be delivered according to the usual practice of the treating health professional. The health professional will determine the treatment they believe to be the most appropriate for their individual patient.
Control group
Active

Outcomes
Primary outcome [1] 292667 0
Disability- Quebec Back Pain Disability
Timepoint [1] 292667 0
Primary outcome measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)
Primary outcome [2] 292746 0
Pain- 100mm VAS
Timepoint [2] 292746 0
Measures will be taken at baseline(pre treatment), 2 months(post treatment), 4 months and 12 months
Secondary outcome [1] 309457 0
Quality of life- SF36
Timepoint [1] 309457 0
Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)
Secondary outcome [2] 309593 0
Depression, anxiety, stress- DASS 21
Timepoint [2] 309593 0
Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)
Secondary outcome [3] 309594 0
Kinesiophobia -TAMPA
Timepoint [3] 309594 0
Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)
Secondary outcome [4] 309595 0
Pain self efficacy -PSEQ
Timepoint [4] 309595 0
Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)

Eligibility
Key inclusion criteria
Experienced chronic low back pain: pain > 3months
Aged 18-65 years
Able to understand spoken and written English
Quebec disability >20
Pain >4 (VAS)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of spinal fracture, tumour, recent spinal surgery, cauda equina symptoms

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following initial contact from the participant, eligibility will be determined by the primary RA. If the participant is eligible they will be randomized into either the intervention group or control group. Randomization will be carried out by the primary RA.
Allocation will be concealed to a second RA who will be at a central administration site. The second RA will be responsible for collecting and assessing outcome measures form both groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A toss of the coin will be used to randomize
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: 40 in each arm
Sample size calculations determined a sample size of 30 was required to detect an effect size of 0.5.
A sample size of 40 was set for each arm to allow for any non-adherence.
Statistical analysis will be undertaken to test for significant change between groups for all measures, P= 0.05 two tailed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2721 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 2722 0
The Sutherland Hospital - Caringbah

Funding & Sponsors
Funding source category [1] 289610 0
Self funded/Unfunded
Name [1] 289610 0
Address [1] 289610 0
Country [1] 289610 0
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Sydney NSW
2006
Country
Australia
Secondary sponsor category [1] 288294 0
None
Name [1] 288294 0
Address [1] 288294 0
Country [1] 288294 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291349 0
University of Sydney
Ethics committee address [1] 291349 0
Level 6
Jane Foss Russell Building
University of Sydney NSW 2006
Ethics committee country [1] 291349 0
Australia
Date submitted for ethics approval [1] 291349 0
24/06/2014
Approval date [1] 291349 0
Ethics approval number [1] 291349 0

Summary
Brief summary
This study aims to test the effectiveness of a patient led goal setting intervention in the treatment of chronic low back pain.
Trial website
Trial related presentations / publications
Public notes
Ethics approval is currently pending. Commencement of recruitment date has been amended

Contacts
Principal investigator
Name 49986 0
Mrs Tania Gardner
Address 49986 0
Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006
Country 49986 0
Australia
Phone 49986 0
+61410449766
Fax 49986 0
Email 49986 0
tgar4750@uni.sydney.edu.au
Contact person for public queries
Name 49987 0
Mrs Tania Gardner
Address 49987 0
Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006
Country 49987 0
Australia
Phone 49987 0
+610410449766
Fax 49987 0
Email 49987 0
tgar4750@uni.sydney.edu.au
Contact person for scientific queries
Name 49988 0
Mrs Tania Gardner
Address 49988 0
Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006
Country 49988 0
Australia
Phone 49988 0
+610410449766
Fax 49988 0
Email 49988 0
tgar4750@uni.sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results