Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000649516
Ethics application status
Approved
Date submitted
8/05/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating physical and psychological care for low back pain
Scientific title
A feasibility study for integrating physical and digital psychological pain management education for persistent low back pain in adults receiving chiropractic or physiotherapy primary care
Secondary ID [1] 312105 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 333740 0
chronic pain 333741 0
Condition category
Condition code
Musculoskeletal 330426 330426 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 330427 330427 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this research project is to determine the feasibility of recruitment of patients with persistent low back pain (LBP) from physiotherapy and chiropractic practices around Australia, who are willing to participate in a psychologically informed eHealth pain management program (known as the Pain Course), in addition to usual care from their musculoskeletal (MSK) clinician.

Australian based registered MSK clinicians in private practice will be recruited into the study.

MSK clinicians will identify and invite eligible patients with persistent LBP to enrol in the Pain Course in addition to providing their usual care. The type, frequency, and duration of MSK care will be recorded.

Participants will engage with the Pain Course in parallel with seeing the MSK clinician. The free, publicly available course comprises 5 core modules, plus additional resources, which are delivered over 8 weeks, with optional phone, email, and private messaging support from a qualified mental health professional (e.g., psychologist, nurse, counsellor).

The lessons provide essential information and teach practical self-management skills to help you do the following:

Understand chronic pain and how it differs from acute pain
Recognise the cycle of symptoms involved in pain, anxiety and depression
Break the cycle of symptoms
Recognise and challenge unhelpful thoughts and beliefs
Recognise and manage physical symptoms of pain, anxiety and depression
Manage levels of day-to-day physical activity safely and confidently, despite pain
Continue to manage your pain and emotional wellbeing once the course has finished

The course can be accessed from the comfort of a person’s home, without the need to attend a physical clinic, using any internet-connected device via email. Adherence to the course is regularly monitored through individual completion of the modules and access to the secure site. Modules are self-paced and time to complete can vary depending on the participant. For a detail description of the course please visit (https://www.mindspot.org.au/treatment/our-courses/pain-course/).

Patients are then followed up 4 months after recruitment and asked to complete a questionnaire regarding pain, psychological function and treatment satisfaction with the Pain Course, in addition to their usual MSK care. Usual MSK care may encompasses manual therapy, exercise therapy, and/or soft tissue therapy.

In addition to the above, MSK clinicians and eligible patients who have enrolled in the study will be sent an email with a separate Participant Information and Consent Form (PCIF) outlining an interview sub-study. Interested participants will reply to the email and be contacted shortly afterwards to arrange a one-on-one semi-structured interview lasting approximately 30 minutes, via Zoom or Teams. The purpose-designed interview guide asks participants about their views and experiences about the addition of the Pain Course and usual care from MSK clinicians. The research team will conduct the interviews.
Intervention code [1] 328546 0
Treatment: Other
Intervention code [2] 328547 0
Rehabilitation
Comparator / control treatment
Participants' demographic, pain, and psychological measures will be compared to those who were recruited by MSK clinicians and do not enroll in the Pain Course.
Control group
Active

Outcomes
Primary outcome [1] 338177 0
recruitment feasibility of patients with persistent LBP from physiotherapy and chiropractic practices around Australian to participate in an eHealth pain management program.
Timepoint [1] 338177 0
Upon conclusion of the study
Secondary outcome [1] 434811 0
The acceptability of the addition of the eHealth pain management program to usual care by determining the barriers and facilitators from both MSK clinicians’ and patients’ perspectives.
Timepoint [1] 434811 0
6 months after completion of recruitment.
Secondary outcome [2] 434813 0
Pain interference
Timepoint [2] 434813 0
Baseline and 4 months post-baseline
Secondary outcome [3] 435071 0
Depression
Timepoint [3] 435071 0
Baseline and 4 months post-baseline
Secondary outcome [4] 435072 0
Anxiety
Timepoint [4] 435072 0
Baseline and 4 months post-baseline
Secondary outcome [5] 435073 0
Pain Intensity
Timepoint [5] 435073 0
Baseline and 4 months post baseline
Secondary outcome [6] 435074 0
Pain self-efficacy
Timepoint [6] 435074 0
Baseline and 4 months post baseline
Secondary outcome [7] 435075 0
Pain Catastrophizing
Timepoint [7] 435075 0
Baseline and 4 months post baseline
Secondary outcome [8] 435076 0
Health service utilization
Timepoint [8] 435076 0
Baseline and 4 months post baseline
Secondary outcome [9] 435077 0
Pain Course satisfaction
Timepoint [9] 435077 0
Baseline and 4 months post baseline

Eligibility
Key inclusion criteria
MSK clinician inclusion criteria:
Registered chiropractors or physiotherapists in private practice who see patients with persistent LBP.

Patient participant inclusion criteria:
[1] experienced LBP pain for more than 6 months, [2] are classified as high risk on using the STarT Back tool (i.e., experience mental health difficulties associated with their LBP), [3] are 18 years of age and older, [4] have regular access to a computer and the internet, [5] able to read and understand English, [6] are not at acute risk of suicide, [7] not already receiving psychological treatment for their pain from a psychologist, [8] not experiencing pain as a result of serious pathology and [9] seeking musculoskeletal care from a chiropractor or physiotherapist either privately or via third party insurance schemes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with acute or sub-acute low back pain
Patients who do not exhibit mental health difficulties associated with their persistent pain
below 18 years

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)
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
Statistical methods / analysis
Descriptive statistics will be utilised to explore characteristics of MSK clinicians utilising the Pain Course service for their patients.

Descriptive statistics and service use history will be utilised to explore characteristics of patients with persistent LBP utilising the Pain Course and compared to those who were referred to the service but did not apply or enrol into the Pain Course.
Generalised estimation equation modelling technique will assess change in outcomes (RMDQ, Pain interference, GAD-7, PHQ-9, PCS, and PSEQ) via an average group effect over time, while accounting for within subject variance. This will be for the patients with persistent LBP who were recruited by MSK clinicians and enrolled in the Pain Course. This is an uncontrolled feasibility study, therefore statements of effectiveness for this model of care are limited, however this will provide preliminary data regarding symptom change over time. Time points used for this are at recruitment and 4 months follow-up.

Interview audio will be recorded via Teams or Zoom and transcribed verbatim (word-for-word), and analysed thematically using Framework Methods. Thematic analysis allows for the identification of recurring ideas (or patterns of meaning) in participant responses, whilst the use of framework methods will help to identify links within and between participant responses based on pre-existing characteristics of interest. For Clinicians we will focus on professional background, length of time in clinical practice, and number of patients referred to the Pain Course. For patients we will utilize level of engagement with the Pain Course, course/duration of LBP, age and CALD backgrounds.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316463 0
Charities/Societies/Foundations
Name [1] 316463 0
Australian Chiropractors Education & Research Foundation
Country [1] 316463 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Country
Australia
Secondary sponsor category [1] 318636 0
University
Name [1] 318636 0
Macquarie University
Address [1] 318636 0
Country [1] 318636 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315252 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315252 0
https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
Ethics committee country [1] 315252 0
Australia
Date submitted for ethics approval [1] 315252 0
19/02/2024
Approval date [1] 315252 0
04/04/2024
Ethics approval number [1] 315252 0
520241676756133
Ethics committee name [2] 315306 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [2] 315306 0
https://www.cqu.edu.au/research/ethics-integrity
Ethics committee country [2] 315306 0
Australia
Date submitted for ethics approval [2] 315306 0
01/05/2024
Approval date [2] 315306 0
10/05/2024
Ethics approval number [2] 315306 0
0000024916

Summary
Brief summary
We propose to test a promising model of care for individuals with persistent LBP that provides immediate access to a psychologically based and internet-delivered pain management intervention in addition to usual care from physiotherapists and chiropractors. While the current study is dedicated to determining feasibility and acceptability of this model of care, we do hypothesise that this approach will broadly be sustainable, scalable, enhance clinical outcomes, economically efficient, improve access to healthcare resources, and increase the capacity of the health system to deliver multi-disciplinary care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134138 0
Dr David Mcnaughton
Address 134138 0
Central Queensland University, 160 Ann Street, Brisbane, QLD 4000
Country 134138 0
Australia
Phone 134138 0
+61 4 22142299
Fax 134138 0
Email 134138 0
d.mcnauhgton@cqu.edu.au
Contact person for public queries
Name 134139 0
David McNaughton
Address 134139 0
Central Queensland University, 160 Ann Street, Brisbane, QLD 4000
Country 134139 0
Australia
Phone 134139 0
+61 422142299
Fax 134139 0
Email 134139 0
d.mcnaughton@cqu.edu.au
Contact person for scientific queries
Name 134140 0
David McNaughton
Address 134140 0
Central Queensland University, 160 Ann Street, Brisbane, QLD 4000
Country 134140 0
Australia
Phone 134140 0
+61 422142299
Fax 134140 0
Email 134140 0
d.mcnaughton@cqu.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


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
No additional documents have been identified.