Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000482167
Ethics application status
Approved
Date submitted
21/03/2019
Date registered
25/03/2019
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and acceptability of the My Back My Plan program for management of acute low back pain in primary care
Scientific title
The feasibility and acceptability of the My Back My Plan program for management of acute low back pain in primary care
Secondary ID [1] 297262 0
n/a
Universal Trial Number (UTN)
n/a
Trial acronym
MBMP
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Low back pain 311359 0
Acute pain 311360 0
Condition category
Condition code
Musculoskeletal 309995 309995 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective single cohort trial design study. This program for low back pain (LBP) is designed to be a low-cost and high-value personalised treatment option that can be delivered in primary care. This trial will test the feasibility and acceptability of the My Back My Plan (MBMP) program at primary care clinics at Macquarie University (MQ Health).

The MBMP program involves interprofessional primary care for acute low back pain. Care will be personalised for each patient based on their clinical presentation and evaluated within a biopsychosocial framework. A combination of assessment findings using the Orebro Musculoskeletal Pain Questionnaire- short form (OMPSQ) score and clinician identified prognostic factors will be used to match the patient with the optimal MBMP Program level once the patient has enrolled into the study: MBMP Standard (includes up to 4 consultations over 2-3 weeks), MBMP Plus (includes up to 10 consultations over 6 weeks) and MBMP Intensive (includes more than 10 consultations and psychology treatment over 6-12 weeks).

The MBMP program is an optimisation of usual care provided at MQ Health and as per usual care, a standard GP consultation is approximately 15 minutes and a standard physiotherapy consultation is approximately 60 minutes for an initial appointment and 30 to 45 minutes for subsequent appointments. The duration and frequency of the psychology treatment will be determined by the treating psychologist and may include face to face or online treatment options. Adherence to the delivery of the program principles will be gleaned from the clinicians and patient questionnaires developed for this study.

Key principles of MBMP Program include:
1. Interdisciplinary patient care: All MBMP patients will have a GP and physiotherapist in their treatment team with a shared plan approach for communication of key information/education messages; psychological therapy may be added when indicated.
2. Early psychosocial evaluation: Relevant psychosocial factors will be evaluated for all patients in the initial assessments (GP and physiotherapist), by interview and screening questionnaire (OMPSQ).
3. A biopsychosocial understanding of LBP underpins patient care: Patient assessments will aim to identify key biological, psychological and social contributors to the patient’s back pain problem.
4. Person-centred treatment program: Clinicians and patient collaboratively develop a personalised treatment plan that addresses identified individual biopsychosocial contributors to their back pain.
5. Focus on self-management: Patients will be taught skills to help self-manage their back pain, prevent recurrences and manage flare-ups.
6. Early review times: Patients will be reviewed by GPs and physiotherapists within 2-3 days of initial consult.
7. Personalised and Stepped care: Optimal program selection will be guided by a protocol based on psychosocial screening (OMPSQ score) as well as clinician-identified factors that have established prognostic value. Care can be stepped up to MBMP Plus or MPMP Intensive for patients who require more interdisciplinary and/or intensive pain management.

Patients will be encouraged to self-manage after 1-2 consultations with the GP (diagnosis, imaging, medications, advice) and 1-2 sessions with the physiotherapist (goal setting, exercise, education, self-management skills), facilitated with a Patient Booklet that has been designed for this program.

Key elements of the MBMP program include:
1. My Back My Plan Patient Booklet: A booklet has been designed as a shared-care resource to facilitate communication between the patient and the health care team, and to support the patient to apply relevant aspects of their My Back My Plan program.
2. Collaborative goal-setting: Meaningful SMART goals will be established in collaboration with the patient, and will be listed in the My Back My Plan Booklet for all members of the health care team to review.
3. Tailored education: Person-centred education, tailored to each patient, regarding their diagnosis, prognosis and the nature of their back pain will be a cornerstone of the program and integrated throughout treatment. Where indicated by psychosocial assessment, education to address unhelpful thoughts and beliefs may be a significant component of treatment. Information in the My Back My Plan Booklet has been designed to support and tailor patient education.
4. Advice about returning to daily activities and work: Patients will be encouraged to gradually return to usual daily activities and work following appropriate rest. This advice will be carefully tailored to the physical requirements of each patient’s usual role and activity level.
5. Individualised physical activity program: Physical activity will be central to the MBMP program. The physiotherapist and GP will prescribe activities and exercises to improve function, reduce fear of movement / re-injury and achieve goals set in collaboration with the patient. Each patient’s physical activity program will be listed in the My Back My Plan Booklet, aided by photographs of exercises and a chart of individualised daily activities.
6. Analgesic medication advice: GPs will discuss the role of analgesic medication in the patients’ recovery plan, with dosing and time-frames established if medications are recommended.
7. Imaging advice: The role of imaging for managing back pain will be discussed with the patient, based on the principle that most patients with common back pain will not require imaging. The My Back My Plan Booklet is designed to help explain the limitations and potential harms of imaging.
Intervention code [1] 313533 0
Treatment: Other
Intervention code [2] 313546 0
Lifestyle
Intervention code [3] 313547 0
Rehabilitation
Comparator / control treatment
N/A as single cohort design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318907 0
Patient-rated acceptability of the program will be assessed using a questionnaire specifically designed for this study.
Timepoint [1] 318907 0
Outcomes will be collected at 1 and 3 months after commencing treatment, by online survey or questionnaire specifically designed for this study.
Primary outcome [2] 318908 0
Clinician-rated feasibility of the program
Timepoint [2] 318908 0
Outcomes will be collected at 1 and 3 months after commencing treatment, by online survey or questionnaire specifically designed for this study.
Secondary outcome [1] 366376 0
Patient reported pain intensity using 0-10 Numerical Rating scale
Timepoint [1] 366376 0
Outcomes will be collected at 1 and 3 months after commencing treatment, by online survey or questionnaire.
Secondary outcome [2] 366377 0
Patient reported global perceived recovery using 11-point Global Back Recovery Scale
Timepoint [2] 366377 0
Outcomes will be collected at 1 and 3 months after commencing treatment, by online survey or questionnaire
Secondary outcome [3] 366378 0
Patient reported pain interference with function using Brief Pain Inventory questionnaire
Timepoint [3] 366378 0
Outcomes will be collected at 1 and 3 months after commencing treatment, by online survey or questionnaire.

Eligibility
Key inclusion criteria
Participants are eligible for this study if they are 18 years or older and have experienced a new onset of low back pain within the past 12 weeks, with or without leg pain and sought care at MQ Health. Participants need to be able to read and understand English to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be eligible if their back pain is due to a serious or specific spinal condition (e.g. fracture, tumour, infection) that requires specialised treatment or if they have previously experienced an episode of low back pain in the last 6 months.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study is a feasibility and acceptability testing of the MBMP program. Consecutive patients will be invited to participate.
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics (IBM SPSS) will be used to analyse and describe clinicians’ ratings of feasibility and patient’s ratings of acceptability and their clinical outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13027 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 25513 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 25514 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 301821 0
University
Name [1] 301821 0
Macquarie University Research Training Program (RTP) full-time scholarship
Country [1] 301821 0
Australia
Primary sponsor type
Individual
Name
Professor Julia Hush
Address
Ground Floor, Department of Health Professions
75 Talavera Rd
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 302103 0
None
Name [1] 302103 0
Address [1] 302103 0
Country [1] 302103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302525 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 302525 0
Macquarie University
NSW, 2109, Australia
Ethics committee country [1] 302525 0
Australia
Date submitted for ethics approval [1] 302525 0
08/11/2018
Approval date [1] 302525 0
08/03/2019
Ethics approval number [1] 302525 0
5201938387497
Ethics committee name [2] 302920 0
MQ Health Clinical Research Executive
Ethics committee address [2] 302920 0
MQ Health and Faculty of Medicine and Health Sciences
Level 3, 75 Talavera Road, Macquarie Park NSW 2113
Ethics committee country [2] 302920 0
Australia
Date submitted for ethics approval [2] 302920 0
05/11/2018
Approval date [2] 302920 0
11/03/2019
Ethics approval number [2] 302920 0
MQCRG2018053

Summary
Brief summary
This project addresses the highest cause of years lived with a disability in Australia: low back pain (LBP). The aim of this project is to conduct a feasibility and acceptability study of a personalised primary care program for acute LBP.

The MBMP program is designed to be a low cost, high value primary care program for acute LBP. It is based on the following principles: (1) Clinicians and patients collaboratively develop a person-centered, individualised treatment plan that addresses identified biopsychosocial contributors to their LBP; (2) Three treatment streams will be available, based on psychosocial screening and clinician-identified factors; (3) All patients receive integrated multidisciplinary care with a GP and a physiotherapist, with psychological therapy added as indicated; (4) Patients will be taught skills to self-manage their LBP and prevent recurrences; (5) A novel patient booklet will facilitate integrated care. The results will inform review of how integration of health care and clinical pathways can optimise primary care for LBP.

The project’s outcomes will be initially translated into clinical practice at MQ Health clinics for this phase 1 trial. Results from this feasibility trial will inform iterative review of the MBMP program, prior to multi-site testing in a fully-powered randomised controlled trial for which we will seek external funding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90518 0
Prof Julia Hush
Address 90518 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Room G813, 75 Talavera Road
Macquarie University, NSW 2109, Australia
Country 90518 0
Australia
Phone 90518 0
+61 298506621
Fax 90518 0
Email 90518 0
[email protected]
Contact person for public queries
Name 90519 0
Ms Malene Ahern
Address 90519 0
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie University, NSW 2109
Country 90519 0
Australia
Phone 90519 0
+61 298502798
Fax 90519 0
Email 90519 0
[email protected]
Contact person for scientific queries
Name 90520 0
Ms Malene Ahern
Address 90520 0
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie University, NSW 2109
Country 90520 0
Australia
Phone 90520 0
+61 298502798
Fax 90520 0
Email 90520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseMy Back My Plan is a feasible and acceptable individualised program for acute low back pain in primary care.2022https://dx.doi.org/10.1071/PY21207
N.B. These documents automatically identified may not have been verified by the study sponsor.