ANZCTR - Registration

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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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

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]

Disability- Quebec Back Pain Disability

Timepoint [1]

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]

Pain- 100mm VAS

Timepoint [2]

Measures will be taken at baseline(pre treatment), 2 months(post treatment), 4 months and 12 months

Secondary outcome [1]

Quality of life- SF36

Timepoint [1]

Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)

Secondary outcome [2]

Depression, anxiety, stress- DASS 21

Timepoint [2]

Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)

Secondary outcome [3]

Kinesiophobia -TAMPA

Timepoint [3]

Measures will be taken at baseline, 2 months(post intervention), 4 months(2 months post) and 12 months(10 months post)

Secondary outcome [4]

Pain self efficacy -PSEQ

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

26/08/2014

Actual

Date of last participant enrolment

Anticipated

30/08/2016

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]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [2]

The Sutherland Hospital - Caringbah

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Sydney

Address

University of Sydney
Sydney NSW
2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

University of Sydney

Ethics committee address [1]

Level 6
Jane Foss Russell Building 
University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/06/2014

Approval date [1]

Ethics approval number [1]

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

Mrs Tania Gardner

Address

Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006

Country

Australia

Phone

+61410449766

Fax

[email protected]

Contact person for public queries

Name

Tania Gardner

Address

Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006

Country

Australia

Phone

+610410449766

Fax

[email protected]

Contact person for scientific queries

Name

Tania Gardner

Address

Faculty of Pharmacy
Science Rd
University of Sydney
NSW 2006

Country

Australia

Phone

+610410449766

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Patient led goal setting in chronic low back pain ... [More Details]
Study results article	Yes		Gardner T,Refshauge K, McAuley J, et al. Combined ... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically