Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001058561
Ethics application status
Approved
Date submitted
22/07/2024
Date registered
2/09/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
2/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial to Evaluate the effect of early multi-disciplinary care on chronicity of transport accident injuries
Scientific title
Pilot trial to evaluate the effect of Early multi-disciplinary care to reduce chronicity of transport accident injuries in adults with Musculoskeletal neck pain
Secondary ID [1] 312579 0
T114
Universal Trial Number (UTN)
U1111-1310-9989
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash 334503 0
Musculoskeletal neck pain 334838 0
Condition category
Condition code
Musculoskeletal 331117 331117 0 0
Other muscular and skeletal disorders
Injuries and Accidents 331437 331437 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be stratified to these pathways based on their clinical presentation and validated risk stratification tools.

Pathway 1 Telehealth Physiotherapy
Unlimited care for up to three months. Treatment may include;
a) Advice and education regarding whiplash injury, usual care guidlines, encouragement to stay gently active and gradually re-engage with usual activities.
b) Exercise prescription including moderate-intensity cardiovascular activities, motor control and resistance exercises in line with standard prescription guidelines.
c) Telehealth session duration will be based on the needs of the client, initial sessions will generallhy take 60 minutes, with follow up sessions taking between 10-30mins.
d) The health pathway can be delivered for up to 3-months, but some patients may feel like they are recovered or managing independently before this time and thus won't have to continue to attend telehealth sessions.
e) Training will be provided by the Chief Investigator in the delivery of Stress-Inoculation training and this will take 6-hours.
f) Training will be delivered prior to recruitment of the first trial participant AND will be delivered either via 1x 6-hour in-person session or 3 x 2-hour online sessions at the therapists preference.
g) Participant adherance with treatment will be monitored via verbal report during sessions and is not being reported on for this trial.
Referred to this pathway if:
1) They are “low-risk” according to WhipPredict and Orebro SF
a. i.e. NDI < 32%, aged < 35 years old.
Delivered by experienced physiotherapists specifically trained to deliver the project intervention. Key components:
1) Advice and education regarding their condition;
2) Goal setting and exploration of meaningful life activities;
3) Graded return to activity; and
4) Exercise prescription.

Pathway 2 Shared-care
Pathway 1 + up to 5 sessions of Face-to-Face Physiotherapy with a local provider.
Referred to this pathway if:
1) They have a preference for in-person care;
2) In-person assessment is warranted (e.g. signs of sensorimotor impairments); and/or
3) In-person treatment is warranted (e.g. recalcitrant movement restriction).
Treatment may include;
a) Usual, pragmatic physiotherapy care including advice and education, exercise prescription, manual therapy, use of external physical devices (e.g. taping), and judicious use of electrophysical agents.
b) Face to face sessions will be 30 minutes in lenght .
c) Examples exercises that may be prescribed during F2F sessions that are less easily prescibed during telehealth sessions include kineaesthetic awareness training using a laser headlamp.

Within this pathway, the care is shared between the face-to-face provider and the expert telehealth physiotherapist. This shared-care will involve collegial support, feedback and peer-review. Barriers to recovery and targets for intervention will be identified and discussed, and advice on current best-practice management will be provided. Liaison will also ensure that care is being delivered efficiently, without doubling up, and is aligned with the participants goals. Liaison will occur in writing and via telephone and/or videoconferencing engagements. There is no prescribed schedule of communication between the therapists, beyond the instruction that contact should be made for every trial participant and then pragmatically as they see fit.

Pathway 3 Multidisciplinary care
Pathway 1 + Pathway 2 + up to 6, 1-hour sessions of Psychology delivered by a registered in-house Psychologist.in-house Axis Psychologist.
Referred to this pathway if at high-risk of delayed recovery:
1) Whip Predict: aged over 35-years-old, NDI score >40%, Posttraumatic Diagnostic Scale score >6
2) Orebro SF scores of >50/100).
Treatment sessions will involve
The Psychology intervention will provide Stress Inoculation Training (SIT) and include the following core components:
1) Understanding stress and pain, and abdominal breathing;
2) Muscle relaxation and body scanning;
3) Problem-solving;
4) Coping Statements;
5) Applying Stress Inoculation Training (SIT) to the real world; and
6) Coping skills maintenance.
Intervention code [1] 329099 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338879 0
Neck pain related disability
Timepoint [1] 338879 0
12-weeks post-intervention commencement
Secondary outcome [1] 437779 0
Acceptability
Timepoint [1] 437779 0
Once off via focus group at a point 12-weeks + post-intervention commencing

Eligibility
Key inclusion criteria
• Adults aged 18-65 years old;
• Musculoskeletal neck pain related to road traffic accident of < 2 months duration; and
• Proficient in English and not requiring translator for appointments.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• A known or suspected serious medical pathology (e.g., metastatic disease, uncontrolled cardiovascular diseases);
• Confirmed fracture or dislocation at time of injury (WAD grade 4);
• Fracture or injuries to other body regions; and
• Serious psychological/psychiatric disorders (e.g. severe depression/ schizophrenia).

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participan ts will be stratified into one of the three intervention pathways based on their clinical presentation and a validated risk stratification tool, i.e WhipPredict.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed-methods pilot study using a single arm pre-post design. There will be two phases;
1) Pilot and evaluation
a. A quantitative evaluation of the potential effectiveness of the stratified care rehabilitation program by assessing the impact on health outcomes pre- to post-intervention.
b. As this is a small single arm pilot study to test feasibility, there is no comparison group and will not be sufficiently powered to detect clinically relevant differences in the health outcome measures. For these reasons, only potential effectiveness can be evaluated. This is in accordance with the recommendations from the Consolidated Standards of Reporting Trials (CONSORT) for the development of pilot and feasibility studies.
2) Qualitative analysis of acceptability and feasibility via invited focus groups.
a. This study will adopt a qualitative research method, utilising principles of interpretive description within an interpretivist paradigm, which is applicable to qualitative inquiry across health professions when a study aims to capture the subjective experience of a population and intends to use this knowledge to inform practice. Data analysis will generally adhere to the thematic analysis approach advocated by Braun and Clarke (2020). The consolidated criteria for reporting qualitative research checklist (COREQ-32) will be used to ensure explicit and comprehensive reporting.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317009 0
Government body
Name [1] 317009 0
Transport Accident Commission
Country [1] 317009 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Axis Rehab
Address
Country
Australia
Secondary sponsor category [1] 319259 0
None
Name [1] 319259 0
Address [1] 319259 0
Country [1] 319259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315767 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 315767 0
Ethics committee country [1] 315767 0
Australia
Date submitted for ethics approval [1] 315767 0
20/08/2024
Approval date [1] 315767 0
23/08/2024
Ethics approval number [1] 315767 0
2024/HE001014

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

Contacts
Principal investigator
Name 135726 0
Prof Michele Sterling
Address 135726 0
RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road HERSTON QLD 4029 Australia
Country 135726 0
Australia
Phone 135726 0
+61733464793
Fax 135726 0
Email 135726 0
[email protected]
Contact person for public queries
Name 135727 0
Nick Kendrick
Address 135727 0
Axis Rehab, Ground Floor, 280 Adelaide Street, Brisbane, QLD, 4001
Country 135727 0
Australia
Phone 135727 0
+61732999441
Fax 135727 0
Email 135727 0
[email protected]
Contact person for scientific queries
Name 135728 0
Nick Kendrick
Address 135728 0
Axis Rehab, Ground Floor, 280 Adelaide Street, Brisbane, QLD, 4001
Country 135728 0
Australia
Phone 135728 0
+61732299221
Fax 135728 0
Email 135728 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
To maintain strict privacy of trial participants and because this would be beyond the scope of consent being sought.


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.