Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000871145
Ethics application status
Approved
Date submitted
4/04/2019
Date registered
19/06/2019
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a novel pathway of care for common musculoskeletal conditions in primary care
Scientific title
Implementation of a novel clinical PAthway of CarE for common musculoskeletal conditions in primary care (PACE study): impact on physical and other health outcomes and costs
Secondary ID [1] 297372 0
National Health and Medical Research Council Project grant: APP1141377
Universal Trial Number (UTN)
Trial acronym
PACE-MSK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 311509 0
Neck pain 311510 0
Osteoarthritis of the Knee 311511 0
Whiplash 312296 0
Condition category
Condition code
Musculoskeletal 310142 310142 0 0
Other muscular and skeletal disorders
Musculoskeletal 310850 310850 0 0
Osteoarthritis
Public Health 310851 310851 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will initially undergo baseline assessment of risk for poor outcome using the Short Form Orebro Musculoskeletal Pain Questionnaire (SF-OMSQ) where scores >50 will indicate high risk of ongoing pain and disability. Participants will also complete the Keele STarT MSK Tool for comparison but it is the scores on the SF-OMSQ that will be used for risk-stratification.
At baseline, participants will complete baseline questionnaires that assess demographic factors, pain and disability and potential effect moderators including validated condition-specific disability measures (e.g., Oswestry Disability Questionnaire, Neck Disability Index, WOMAC).
Participants will then be randomised to usual care or the clinical pathway of care (PACE).
Clinical Pathway of Care (PACE). Participants randomised to PACE will receive matched care according to their risk of poor outcome.
Low risk: Once a participant’s risk of recovery is identified, those with a good prognosis (low risk) should do well with minimal care delivered by the participant's primary health care professional (e.g., general practitioner, physiotherapist, chiropractor or osteopath). Those stratified to low risk will receive minimal intervention (between 1-4 sessions of guideline-based care consisting of advice and exercises). Participants will also be directed to the custom-designed online musculoskeletal e-hub resource (MY PAIN HUB) which will have links to existing evidence informed guideline-based resources developed by the research team. The research assistants will contact participants by phone (1 week and 4-6 weeks post randomisation) and encourage them to access this site for information, advice, exercise pages and to watch the videos.
Information in MY PAIN HUB has been adapted from the most recent evidence-based guidelines for each condition. It is a one access portal bringing together all the resources to facilitate easy access and utilisation by primary health care professionals managing whiplash/neck pain, low back pain and or knee OA. In Australia, existing resources include the development and implementation of a website for whiplash (CI Rebbeck, CI Sterling, CI Cameron, AI Ritchie), for osteoarthritis (CI Simic, AI Bennell) and in the UK, low back pain (AI Foster). Each resource provides guideline-based information for first line care (such as provision of advice and simple exercises), recommendations on the appropriate use of musculoskeletal imaging, validated risk-stratification tools for clinicians, and recommendations on when referral for specialist care is required. Guideline based information for each condition is based on:
Knee OA: RACGP Guidelines for the management of knee and hip osteoarthritis; https://www.racgp.org.au/download/Documents/Guidelines/Musculoskeletal/guideline-for-the-management-of-knee-and-hip-oa-2nd-edition.pdf
Whiplash: State Insurance Regulatory Authority (SIRA) Whip Lash guidelines; https://www.sira.nsw.gov.au/resources-library/motor-accident-resources/publications/for-professionals/whiplash-resources/SIRA08104-Whiplash-Guidelines-1117-396479.pdf
Neck Pain: National Institute for Health and Care Excellence (NICE) Neck Pain guidelines; https://www.evidence.nhs.uk/search?q=NICE%20guidelines%20on%20treatment%20of%20neck%20pain
Back Pain: The Agency for Clinical Innovation (ACI) acute low back pain guidelines
https://www.aci.health.nsw.gov.au/resources/musculoskeletal/management-of-people-with-acute-low-back-pain/albp-model
www.mybackpain.org.au
E-health educational videos /webinars for primary health care professionals for each condition will be developed by the CI and AI team according to relevant expertise. The e-Health implementation process for the low risk group will be advised by AI Shaw (e-health Professor) and AI Foster who have completed similar strategies in the UK. Health professionals will be able to access these resources as required through the MY PAIN HUB.
Intervention for those at high risk.
Participants at high risk of poor outcome will be referred to a specialist musculoskeletal clinician within 4 weeks of randomisation.
Specialist Musculoskeletal Clinicians will be recruited by the chief investigators prior to study commencement. For the purposes of clarity in this study, a specialist is defined as a health care professional who have a higher degree or fellowship qualifications in musculoskeletal health or who have recognised expertise in the management of complex musculoskeletal conditions for example, those that have been independently appointed by workers’ compensation and motor vehicle injury insurance regulators to perform peer review, consultancy and dispute resolution services for complex musculoskeletal injuries and disorders). These specialist musculoskeletal clinicians most commonly are physiotherapists, but can also include psychologists, chiropractors and medical practitioners. Prior to the commencement of the trial, specialist musculoskeletal clinicians at each treatment site will be trained to implement the pathway of care in a 1-2-day advanced musculoskeletal workshop conducted by the CI’s. The content of each workshop will be developed by the CI and AI team who are currently world leaders in their relative areas.
The specialist musculoskeletal clinician will conduct a thorough assessment based on an individual participant's presentation and include examination of factors known to be associated with poor outcome (e.g., physical, pain-related and psychological factors) and then make one of three decisions:
1. Shared care: The specialist musculoskeletal clinician liaises with the primary health care professional on best management. Example scenarios include when the participant has
localised symptoms.
2. Specialist care: Up to 6 sessions of specialist-led care addressing the assessed impairments using a psychologically informed cognitive/ behavioural approach. This pathway will be chosen when the treating practitioner may be less confident in managing the participant's presentation or when presentation is more complex.
3. Referred care: For example, to a psychologist when scores on screening questionnaires for psychological factors (e.g., depression or post-traumatic stress) are above threshold levels, to a medical pain specialist when pain features are above threshold (e.g., clinical indication of pain sensitivity) or to an orthopaedic surgeon when advanced osteoarthritis is present.
Specialist musculoskeletal clinicians will be given guidance during their training about when to make these decisions.
Patient and health professional questionnaires and health professional interviews will be used to assess and monitor adherence to the intervention.
Intervention code [1] 313626 0
Diagnosis / Prognosis
Intervention code [2] 313628 0
Treatment: Other
Comparator / control treatment
Participants randomised to usual care will receive care regardless of their prognostic risk. Usual care will be provided by their nominated primary health care professional who will not be informed of the risk category, but will be sent a letter informing them of their patient’s involvement in the trial. Decisions regarding the number of treatment sessions, content of management (assessment and treatment), and referral to other professionals will depend on the clinical judgment of the primary health care professional. Health professional practice prescribed will be collected from their patients at all follow up time points. No attempt to change usual care of participants will be made.
Control group
Active

Outcomes
Primary outcome [1] 319043 0
The primary outcome measure is physical health (as measured by the physical component subscale of the SF12 i.e., the SF12-PCS).
Timepoint [1] 319043 0
The primary outcome (SF12-PCS) will be measured at 12 months.
Secondary outcome [1] 366787 0
Pain Self Efficacy Questionnaire,
A validated and widely used tool to assess the confidence people with pain have in performing activities while in pain. Assessment of self-efficacy was chosen as an outcome of interest because the intervention chosen aims to enhance confidence to self-manage regardless of symptoms after 3 months. Pain self-efficacy has significantly improved in other trials of musculoskeletal pain.
Timepoint [1] 366787 0
3, 6, 12 months post intervention
Secondary outcome [2] 369631 0
Low Back pain disability will be measured with the validated Oswestry Disability Index (ODI) for low back pain,
Timepoint [2] 369631 0
3,6,12 Months
Secondary outcome [3] 369632 0
Neck pain disability will be measured with the validated Neck Disability Index (NDI) for neck pain,
Timepoint [3] 369632 0
3,6,12 months
Secondary outcome [4] 369633 0
We will use the physical function subscale of the WOMAC.
Timepoint [4] 369633 0
3,6,12 months
Secondary outcome [5] 369634 0
Generic health and disability will be measured with the validated World Health Organization disability assessment schedule II short form (WHODASII)
Timepoint [5] 369634 0
3,6,12 months
Secondary outcome [6] 371457 0
Patient depression, anxiety and tension/stress will be measured using the validated depression anxiety stress scale (DASS-21)
Timepoint [6] 371457 0
3, 6, 12 months
Secondary outcome [7] 371458 0
Patients thoughts and feelings about their pain will be measured using the validated pain catastrophising scale (PCS)
.
Timepoint [7] 371458 0
3, 6, 12 months

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they are within 4 weeks of seeking care (or are planning to seek care) for their symptoms and are proficient in written and spoken English. Participants with LBP must fulfil criteria for non-specific LBP with/ without associated leg symptoms, and be aged over 18-years. Participants with neck pain or WAD must fulfil criteria for non-specific neck pain and/or grade I-III WAD and be aged over 18-years. Inclusion criteria for participants with knee OA will be confirmed using the National Institute for Health and Clinical Excellence (NICE) criteria (at least 45-years old, experience activity-related joint pain, and have either no morning joint-related stiffness or morning stiffness lasting <30 minutes). Participants at all stages of knee OA who have experienced pain for longer than 3-months will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology (e.g. metastatic disease of the spine)
Confirmed fracture or dislocation at time of injury (WAD IV).
Extreme depression defined as at risk of self-harm (answering yes to Item 9 of the Patient Health Questionaire-9 (PHQ-9)).
Above average health according to the SF12 (>80/100 on the transformed score)
Knee OA patients excluded if they have undergone or are scheduled for joint replacement surgery.

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)
The randomisation schedule will be prepared by the NHMRC clinical trial centre randomisaiton service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will complete the SF-ÖMSPQ and be stratified into low risk (scores <50), or high risk (scores =50) of poor outcome. Risk status and MSK condition (low back pain, neck pain/WAD, knee osteoarthritis), will factor in randomisation to PACE or usual care. The randomisation process will be managed by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre at The University of Sydney to achieve balance overall with respect to risk subgroup and MSK condition
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation was initially based on the SF12-PCS and the most conservative estimate of the clinically important difference in physical health for the included MSK conditions (low back pain; mean change 3.18, SD 7.7). Originally, the sample size was inflated fourfold to allow for subgroup analysis by condition (low back pain, neck pain/WAD, knee osteoarthritis). Because of the impact of COVID-19 on recruitment and the trial budget, we recalculated the sample size using the actual SD from the baseline data of the first 220 participants (SD=8.5). Thus, a sample size of 304 is required (n=152 PACE, n=152 usual care) to achieve 90% power to reject the null hypothesis of equal means, if the population mean difference between the two trial arms is 3.18 (SD=8.5); significance level (alpha 5%), effect size overall between trial arms of 0.37 using a two-sided two-sample equal-variance t-test. For sufficient power to conduct sub-group analysis of the high risk subgroup (high risk PACE vs high risk usual care, assuming ~40% of participants are high risk), a total sample size of 716 is required. This assumes superiority only in the high risk group, and allows for a 15% lost to follow-up, hence 179 participants in each subgroup are required (i.e., 179 in each of the low and high risk subgroups, in PACE and usual care).

We will use intention-to-treat analyses, whereby all participants will be included in their randomised treatment groups regardless of their post-randomisation behaviour. Analyses will be conducted by a statistician blinded to treatment group, with two-sided hypothesis tests.

A detailed statistical analysis plan will be made publicly available prior to the commencement of data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2020
Actual
20/03/2020
Date of last participant enrolment
Anticipated
16/10/2023
Actual
Date of last data collection
Anticipated
16/10/2023
Actual
Sample size
Target
716
Accrual to date
716
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 13141 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13143 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 13144 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 13154 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 13489 0
St John of God Hospital, Midland - Midland
Recruitment hospital [6] 13882 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 25683 0
2050 - Camperdown
Recruitment postcode(s) [2] 25685 0
2065 - St Leonards
Recruitment postcode(s) [3] 25686 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 25696 0
3084 - Heidelberg
Recruitment postcode(s) [5] 26108 0
6056 - Midland
Recruitment postcode(s) [6] 26654 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301939 0
Government body
Name [1] 301939 0
National health and Medical Research Council
Country [1] 301939 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Cumberland Campus
75 East St. Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 301696 0
University
Name [1] 301696 0
Curtin University
Address [1] 301696 0
Kent Street
Bentley
WA 6102
Country [1] 301696 0
Australia
Secondary sponsor category [2] 302291 0
University
Name [2] 302291 0
The University of Queensland
Address [2] 302291 0
RECOVER Injury Research Centre
288 Herston Rd
Brisbane City
QLD 4029
Country [2] 302291 0
Australia
Secondary sponsor category [3] 302292 0
University
Name [3] 302292 0
The University of Melbourne
Address [3] 302292 0
Grattan Street
Parkville
Vic, 3010
Country [3] 302292 0
Australia
Other collaborator category [1] 280540 0
Individual
Name [1] 280540 0
Dr Milena Simic
Address [1] 280540 0
The University of Sydney
Cumberland Campus
75 East Street
Lidcombe
NSW 2141
Country [1] 280540 0
Australia
Other collaborator category [2] 280543 0
Individual
Name [2] 280543 0
Dr Darren Beales
Address [2] 280543 0
Curtin University
Kent Street
Bentley
WA 6102
Country [2] 280543 0
Australia
Other collaborator category [3] 280545 0
Individual
Name [3] 280545 0
Associate Professor Paulo Ferreira
Address [3] 280545 0
The University of Sydney
Camperdown
NSW 2006
Country [3] 280545 0
Australia
Other collaborator category [4] 280546 0
Individual
Name [4] 280546 0
Professor Ian Cameron
Address [4] 280546 0
Sydney Medical School Northern,
Faculty of Medicine
University of Sydney
Camperdown
NSW 2006
Country [4] 280546 0
Australia
Other collaborator category [5] 280547 0
Individual
Name [5] 280547 0
Professor Michele Sterling
Address [5] 280547 0
Faculty of Health and Behavioural Sciences,
The University of Queensland
Level 7, UQ Oral Health Centre,
288 Herston Road, Herston
QLD 4006
Country [5] 280547 0
Australia
Other collaborator category [6] 280548 0
Individual
Name [6] 280548 0
Professor Michael Nicholas
Address [6] 280548 0
Pain Management Research Institute, Northern Clinical School
Kolling Institute of Medical Research
Royal North Shore Hospital,
Pacific Hwy, St Leonards
NSW 2065, Australia
Country [6] 280548 0
Australia
Other collaborator category [7] 280549 0
Individual
Name [7] 280549 0
Professor Lyndal Trevena
Address [7] 280549 0
School of Public Health
University of Sydney
Camperdown
NSW 2006
Country [7] 280549 0
Australia
Other collaborator category [8] 280550 0
Individual
Name [8] 280550 0
Professor Luke Connolly
Address [8] 280550 0
Centre for the Business and Economics of Health
Faculty of Business, Economics and Law
University of Queensland
St Lucia,
Queensland 4072
Country [8] 280550 0
Australia
Other collaborator category [9] 280551 0
Individual
Name [9] 280551 0
Professor Kathryn Refshauge
Address [9] 280551 0
Faculty of Health Sciences
The University of Sydney.
NSW 2006
Country [9] 280551 0
Australia
Other collaborator category [10] 280552 0
Individual
Name [10] 280552 0
Dr Kerrie Evans
Address [10] 280552 0
Faculty of Health Sciences
The University of Sydney.
NSW 2006
Country [10] 280552 0
Australia
Other collaborator category [11] 280553 0
Individual
Name [11] 280553 0
Professor Kim Bennell
Address [11] 280553 0
The University of Melbourne
Grattan Street
Parkville
Victoria 3010
Country [11] 280553 0
Australia
Other collaborator category [12] 280727 0
Individual
Name [12] 280727 0
Sarah Schwartz
Address [12] 280727 0
The University of Melbourne
Centre for Health, Exercise and Sports Medicine | Department of Physiotherapy
Level 7, Alan Gilbert Building
161 Barry Street
Parkville
Victoria 3010

Country [12] 280727 0
Australia
Other collaborator category [13] 280728 0
Individual
Name [13] 280728 0
Sarah Robins
Address [13] 280728 0
RECOVER Injury Research Centre
288 Herston Rd
Brisbane City
QLD 4029
Country [13] 280728 0
Australia
Other collaborator category [14] 280729 0
Individual
Name [14] 280729 0
Eileen Boyle
Address [14] 280729 0
Curtin University
Kent Street
Bentley
WA 6102
Country [14] 280729 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302621 0
University of Sydney, Human research and Research Integrity and Ethics
Ethics committee address [1] 302621 0
Ethics committee country [1] 302621 0
Australia
Date submitted for ethics approval [1] 302621 0
05/12/2018
Approval date [1] 302621 0
21/03/2019
Ethics approval number [1] 302621 0
2018/926

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

Contacts
Principal investigator
Name 90850 0
Dr Trudy Rebbeck
Address 90850 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital
75 East Street Lidcombe
The University of Sydney
NSW 2141
Country 90850 0
Australia
Phone 90850 0
+61411100600
Fax 90850 0
Email 90850 0
trudy.rebbeck@sydney.edu.au
Contact person for public queries
Name 90851 0
Trudy Rebbeck
Address 90851 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital:
75 East Street Lidcombe
The University of Sydney
NSW | 2141
Country 90851 0
Australia
Phone 90851 0
+61411100600
Fax 90851 0
Email 90851 0
trudy.rebbeck@sydney.edu.au
Contact person for scientific queries
Name 90852 0
Trudy Rebbeck
Address 90852 0
The University of Sydney
Faculty of Health Sciences, Discipline of Physiotherapy:
John Walsh Centre for Rehabilitation Research, Kolling Institute, Royal North Shore Hospital:
75 East Street Lidcombe
The University of Sydney
NSW | 2141
Country 90852 0
Australia
Phone 90852 0
+61411100600
Fax 90852 0
Email 90852 0
trudy.rebbeck@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study will aggregate data prior to report and publication


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20673Ethical approval    376948-(Uploaded-02-11-2021-13-53-58)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20673Ethical approval    376948-(Uploaded-02-11-2021-13-53-58)-Study-related document.pdf
23730Ethical approval   

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: Protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial).2021https://dx.doi.org/10.1136/bmjopen-2021-057705
N.B. These documents automatically identified may not have been verified by the study sponsor.