Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000835640
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
6/08/2014
Date last updated
6/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient led goal setting in chronic low back pain- pilot study
Scientific title
Is patient led goal setting effective in reducing disability and pain in chronic low back pain?
Secondary ID [1] 285051 0
Nil known
Universal Trial Number (UTN)
U1111-1159-6859
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 292573 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292877 292877 0 0
Physiotherapy
Musculoskeletal 292965 292965 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient led goal setting sessions will be facilitated by a physiotherapist (RA) 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. The initial session will take approximately 1 hour and subsequent sessions will take approximately 30 minutes. There will be a final session at the 12-month follow-up. Together with the RA, participants randomized to the patient centred care group will identify the problems that are most important to them, practical strategies to address each of these problems, andspecify 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 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] 289885 0
Rehabilitation
Comparator / control treatment
Nil control group used to compare as this study is a pilot study investigating effectiveness and feasibility of the intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292747 0
Disability- Quebec Back Pain disability
Timepoint [1] 292747 0
Baseline, 2 months (post treatment), 4 months,12 months
Primary outcome [2] 292748 0
Pain- 100mm VAS
Timepoint [2] 292748 0
Baseline, 2 months (post treatment), 4 months, 12 months
Secondary outcome [1] 309596 0
Quality of life- SF36
Timepoint [1] 309596 0
Baseline, 2 months (post treatment), 4 months, 12 months
Secondary outcome [2] 309597 0
Depression, anxiety, stress- DASS21
Timepoint [2] 309597 0
Baseline, 2 months (post treatment), 4 months, 12 months
Secondary outcome [3] 309598 0
Kinesiophobia -TAMPA
Timepoint [3] 309598 0
Baseline, 2 months (post treatment), 4 months, 12 months
Secondary outcome [4] 309599 0
Pain self efficacy- PSEQ
Timepoint [4] 309599 0
Baseline, 2 months (post treatment), 4 months, 12 months

Eligibility
Key inclusion criteria
Experience chronic low back pain: pain > 3 months
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
Sex
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following initial contact from the participant, eligibility will be determined. If eligibility criteria are met, the person will be enrolled into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil randomisation methods
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 20 was determined as this was a pilot study investigating preliminary efficacy and feasibility. The sample size would allow for statistical analysis and detection of clinically relevant improvements in measures of disability and pain. P=0.05 two tailed.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
2/04/2012
Date of last participant enrolment
Anticipated
1/11/2013
Actual
29/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2768 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 8466 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 8467 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 289658 0
Self funded/Unfunded
Name [1] 289658 0
Country [1] 289658 0
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 288349 0
None
Name [1] 288349 0
Address [1] 288349 0
Country [1] 288349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291394 0
HREC University of Sydney
Ethics committee address [1] 291394 0
Ethics committee country [1] 291394 0
Australia
Date submitted for ethics approval [1] 291394 0
Approval date [1] 291394 0
13/03/2012
Ethics approval number [1] 291394 0
14411

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

Contacts
Principal investigator
Name 50194 0
Mrs Tania Gardner
Address 50194 0
Faculty of Pharmacy
Science Building
University of Sydney
NSW 2006
Country 50194 0
Australia
Phone 50194 0
+61410449766
Fax 50194 0
Email 50194 0
[email protected]
Contact person for public queries
Name 50195 0
Tania Gardner
Address 50195 0
Faculty of Pharmacy
Science Building
University of Sydney
NSW 2006
Country 50195 0
Australia
Phone 50195 0
+61410449766
Fax 50195 0
Email 50195 0
[email protected]
Contact person for scientific queries
Name 50196 0
Tania Gardner
Address 50196 0
Faculty of Pharmacy
Science Building
University of Sydney
NSW 2006
Country 50196 0
Australia
Phone 50196 0
+61410449766
Fax 50196 0
Email 50196 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Patient led goal setting resulted in significant i... [More Details]
Study results articleYes Gardner T, Refshauge K, McAuley J, Goodall S, Hübs... [More Details]

Documents added automatically
No additional documents have been identified.