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Trial registered on ANZCTR


Registration number
ACTRN12611000053921
Ethics application status
Approved
Date submitted
14/01/2011
Date registered
17/01/2011
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of a consumer pamphlet for low back pain
Scientific title
Evaluation of the effectiveness (improving beliefs about LBP and minimising fear avoidance behaviours related to LBP) of a consumer pamphlet for the self management of low back pain.
Secondary ID [1] 253419 0
Nil
Universal Trial Number (UTN)
U1111-1119-0440
Trial acronym
cpLBP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 260964 0
Condition category
Condition code
Musculoskeletal 259101 259101 0 0
Other muscular and skeletal disorders
Public Health 259102 259102 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized, controlled trial, consisting of 3 study arms (A, B and C), will be undertaken in partnership with 20 community pharmacies in the Perth, Western Australia, metropolitan area.

Arm B: Pamphlet only: pharmacists will be asked to invite the next 12 customers, after the control participants have been recruited, and who meet the inclusion criteria, to participate in the study (N=120). In this arm, participants will receive a pamphlet from the pharmacist without any further information about self management, other than usual instructions from the pharmacist relating to medication intake, dosage and side-effects. Baseline data will be collected prior to the pamphlet being provided.

Arm C: Pamphlet with education (pharmacies 11-20): pharmacists will be asked to invite the first 12 customers who meet the inclusion criteria to participate in the study (N=120). In this arm, participants will receive a pamphlet from the pharmacist and the pharmacist will review the content of the pamphlet with the participant. Information provided by pharmacists will be standardised. Baseline data will be collected prior to the pamphlet and prior to any further information being provided. The role of the pharmacist will be to reinforce the key messages contained in the pamphlet.

The consumer pamphlet contains evidence-based information about the course of, and self management strategies for, acute and chronic LBP. The pamphlet is aimed at individuals who seek care for, or information about, LBP in primary care settings (eg pharmacies, GP practices, allied health practices). The pamphlet has undergone a period of consultation with key professional health bodies and health stakeholders. The pamphlet content is supported by the Australian Clinical Psychology Association, Australian and New Zealand College of Anaesthetists, Australian Osteopathic Association, Australian Pain Society, Australian Physiotherapy Association, Australian Rheumatology Association (WA), Chiropractors’ Association of Australia, Health Consumers’ Council, Pharmaceutical Society of Australia (WA) and the Royal Australian College of General Practitioners. The intervention will be conducted as a single trial with anticipated recruitment running over a 6 month period with a completion date estimated at September 2011.
Intervention code [1] 257863 0
Behaviour
Comparator / control treatment
Arm A: Control (pharmacies 1-10): pharmacists will be asked to invite the first 12 customers who meet the inclusion criteria to participate in the study as a control (N=120). In the control arm, customers will not receive any information about self management for LBP (ie will receive ‘usual care’ only). Usual care is defined as the standard care and service delivered by pharmacists when providing any prescription medication for use in the management of low back pain or any over the counter analgesic medication for the management of low back pain. Standard care includes the standard advice in regard to taking medications for the management of low back pain. No additional and specific self management instruction or written information will be provided.
Control group
Active

Outcomes
Primary outcome [1] 261951 0
Beliefs about back pain will be collected using the Back Pain Beliefs Questionnaire (BPBQ)
Timepoint [1] 261951 0
Baseline (T0) and then at 2 weeks (T1), and 8 weeks (T2) post
Primary outcome [2] 261952 0
Fear avoidance behaviours will be collected using the Fear Avoidance Beliefs Questionnaire (FABQ)
Timepoint [2] 261952 0
Baseline (T0) and then at 2 weeks (T1), and 8 weeks (T2) post
Secondary outcome [1] 268864 0
Demographic (age, gender, highest level of education, employment status)
Timepoint [1] 268864 0
Baseline (T0)
Secondary outcome [2] 268865 0
Pain history characteristics (duration of symptoms)
Timepoint [2] 268865 0
Baseline (T0)
Secondary outcome [3] 268866 0
Global Perceived Impression of Usefulness (11 point NRS)
Timepoint [3] 268866 0
at 2 weeks (T1), and 8 weeks (T2) post baseline
Secondary outcome [4] 268867 0
Participating pharmacists will be surveyed regarding their perceptions of the usefulness of the pamphlet.
Timepoint [4] 268867 0
At the completion of the patient intervention trial

Eligibility
Key inclusion criteria
Any pharmacy customer aged 18-65 years who is currently experiencing low back pain and has adequate understanding of written and spoken English is eligible to participate
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria for this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomized, controlled trial, consisting of 3 study arms (A, B and C), will be undertaken in partnership with 20 community pharmacies in the Perth metropolitan area. A convenience sample of pharmacies will be selected through the Pharmaceutical Society of WA. Participating pharmacies will cover major zones of the Perth metropolitan area to represent a range of socioeconomic profiles. Ten pharmacies will be involved in both the ‘control’ (A) and ‘pamphlet only’ (B) arms while a separate ten pharmacies will be involved in the ‘pamphlet with education’ (C) arm only. Pharmacies will be randomly allocated to study groups. Each pharmacist who participates will receive training from the evaluation team according to their allocated study arm and will receive a modest remuneration for recruitment of consumers. Each pharmacy will recruit 12 consecutive customers who meet the inclusion criteria for each study arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
9/05/2011
Date of last participant enrolment
Anticipated
Actual
31/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 258330 0
Government body
Name [1] 258330 0
Department of Health WA
Country [1] 258330 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 257488 0
Other Collaborative groups
Name [1] 257488 0
Musculoskeletal Health Network
Address [1] 257488 0
Health Networks Branch, Office of the Chief Medical Officer
Department of Health WA
PO Box 8172
Perth Business Centre, WA, 6849
Country [1] 257488 0
Australia
Other collaborator category [1] 251773 0
Other Collaborative groups
Name [1] 251773 0
Pharmaceutical Society of WA
Address [1] 251773 0
21 Hamilton St
Subiaco 6008
Perth, Western Australia
Country [1] 251773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260309 0
Curtin University Human Research Ethics Commitee
Ethics committee address [1] 260309 0
Office of Research and Development
Curtin University
GPO Box U 1987
Perth WA 6845
Ethics committee country [1] 260309 0
Australia
Date submitted for ethics approval [1] 260309 0
Approval date [1] 260309 0
12/01/2011
Ethics approval number [1] 260309 0
HR171/2010

Summary
Brief summary
The aim of this project is to undertake an evaluation of a consumer-oriented pamphlet for the self management of low back pain within a primary care context. The project will determine whether providing the pamphlet to individuals who visit a community pharmacy to purchase pain-relieving medications for low back pain is effective (with and without additional education from the pharmacist) compared to not providing the pamphlet. Effectiveness is defined as improving consumer beliefs about low back pain and minimising fear avoidance behaviours related to low back pain. when appropriate, messages are targeted towards best-practice self management of spinal pain. Where additional support is required, a recommendation to seek evidence-based guidance from a health professional is encouraged.

Primary hypothesis: Providing this low back pain educational pamphlet to consumers who visit a community pharmacy to purchase pain-relieving medications for LBP improves beliefs about LBP and minimises fear avoidance behaviours compared to usual care.
Trial website
Trial related presentations / publications
Slater H, Briggs AM, Watkins K, Chua J, Smith AJ (2013) Translating Evidence for Low Back Pain Management into a Consumer-Focussed Resource for
Use in Community Pharmacies: A Cluster-Randomised Controlled Trial. PLoS ONE 8(8): e71918. doi:10.1371/journal.pone.0071918
Public notes

Contacts
Principal investigator
Name 32095 0
A/Prof Helen Slater
Address 32095 0
School of Physiotherapy and Exercise Science, Curtin University GPO Box U1987, Perth WA 6845
Country 32095 0
Australia
Phone 32095 0
+61 8 9266 3099
Fax 32095 0
Email 32095 0
[email protected]
Contact person for public queries
Name 15342 0
Jason Chua
Address 15342 0
School of Physiotherapy and Exercise Science, Curtin University GPO Box U1987, Perth WA 6845
Country 15342 0
Australia
Phone 15342 0
+ 61 8 9266 4644
Fax 15342 0
+ 61 8 9266 3699
Email 15342 0
[email protected]
Contact person for scientific queries
Name 6270 0
Helen Slater
Address 6270 0
School of Physiotherapy and Exercise Science, Curtin University GPO Box U1987, Perth WA 6845
Country 6270 0
Australia
Phone 6270 0
+ 61 8 9266 3099
Fax 6270 0
+ 61 8 9266 3699
Email 6270 0
[email protected]

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No Supporting Document Provided



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