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Trial registered on ANZCTR


Registration number
ACTRN12625000044426p
Ethics application status
Submitted, not yet approved
Date submitted
5/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Taking the plunge. Combined education and learning to swim for low back pain
Scientific title
Taking the plunge. Combined education and learning to swim for adults with persistent low back pain
Secondary ID [1] 313315 0
RSH/6802
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 335668 0
Condition category
Condition code
Musculoskeletal 332227 332227 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 332448 332448 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Brief educational messages provided to participants. These are readily available video / online resources (reference list below):

1. 'Tame the Beast: It’s Time to Rethink Persistent Pain" is designed to educate viewers on the neuroscience behind persistent pain, encouraging a shift in mindset about pain as a brain-based experience. It highlights concepts like neuroplasticity, emotional influence, and the brain's role in pain perception to empower viewers in managing chronic pain.

2. "Understanding Pain in Less than 5 Minutes" explains how pain works and the factors that influence it, while offering strategies to manage pain more effectively. It is aimed at helping individuals, especially parents and healthcare providers, to better understand pain and improve patient outcomes.

These videos were assessed and considered of ‘high user engagement’ (1) and are freely available for the public and knowingly focus on simplified explanations and engaging formats like animations, thus making made complex topics accessible and engaging.

References:
1. Heathcote LC, Pate JW, Park AL, Leake HB, Moseley GL, Kronman CA, et al. Pain neuroscience education on YouTube. PeerJ. 2019;7:e6603.


- Participants will be asked to watch both videos prior to commencing the learn to swim program
- learn to swim program comprising 8 weeks, 2 x week for 30 minutes duration
- learn to swim supervised and taught by a qualified learnt to swim teacher or accredited swimming coach
- lesson contents include but not limited to:
* Water Familiarization
* Breath Control and Submersion
* Floating and Buoyancy
* Kicking and Arm Movements
* Body Position and Streamlining
* Stroke Development
* Basic Safety and Survival Skills
* Gradual Distance Swimming
- lessons will be conducted at approved urban and regional aquatic centers face-to-face
- people with back pain may be either in a group or individual session, depending on participant and instructor time and availability.
- instructor will take note of and document participant attendance.
Intervention code [1] 329891 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339801 0
Recruitment
Timepoint [1] 339801 0
Tracked continuously throughout the recruitment period, e.g. scheduled to occur once every week, starting from the initiation of the intervention, and will continue weekly for a total of twelve weeks after the intervention (recruitment) begins.
Primary outcome [2] 339802 0
Retention
Timepoint [2] 339802 0
At the end of study period (8 weeks)
Primary outcome [3] 339803 0
Participant acceptability to the intervention.
Timepoint [3] 339803 0
End of study e.g., 8 weeks.
Secondary outcome [1] 441410 0
Fear avoidance behaviour
Timepoint [1] 441410 0
Baseline and 3 months post intervention commencement
Secondary outcome [2] 441411 0
Physical activity
Timepoint [2] 441411 0
Baseline and 3 months post intervention commencement
Secondary outcome [3] 441413 0
Pain
Timepoint [3] 441413 0
Baseline and 3 months post intervention commencement
Secondary outcome [4] 441414 0
Disability
Timepoint [4] 441414 0
Baseline and 3 months post intervention commencement
Secondary outcome [5] 441415 0
Pain self-efficacy
Timepoint [5] 441415 0
Baseline and 3 months post intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Adults aged 18 years +
2. Persistent low back pain (LBP) >12 weeks
3. Pain intensity >2/10 (numerical pain rating scale (NPRS)
4. Desire to learn to swim
5. Able to complete pain education program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Inability to comprehend written English
2. Recent lumbar spine surgery
3. Signs and symptoms indicative of serious pathology causing LBP (bowel or bladder dysfunction, change in sensation in the perineal region, worsening pain at night, recent fevers/illness, or recent worsening of neurological symptoms in the lower legs, i.e., pins and needles, numbness, sensory loss, muscle weakness).

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary aim of this feasibility study is to assess the practicality of conducting a full-scale trial rather than to draw definitive statistical conclusions. Descriptive statistics (e.g., means, medians, proportions) will be used to summarize key feasibility outcomes, including recruitment rates, retention rates, and adherence to the intervention. Simple inferential statistics (e.g., confidence intervals) may be applied where appropriate to assess variability and guide sample size calculations for future studies. The sample size for this study is based on feasibility considerations rather than statistical power, ensuring sufficient representation to explore logistical challenges and refine study protocols.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317761 0
University
Name [1] 317761 0
CQUniversity
Country [1] 317761 0
Australia
Primary sponsor type
University
Name
CQUniversity
Address
Country
Australia
Secondary sponsor category [1] 320082 0
None
Name [1] 320082 0
Address [1] 320082 0
Country [1] 320082 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316454 0
CQ University's Human Research Ethics Committee
Ethics committee address [1] 316454 0
Ethics committee country [1] 316454 0
Australia
Date submitted for ethics approval [1] 316454 0
30/11/2024
Approval date [1] 316454 0
Ethics approval number [1] 316454 0

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

Contacts
Principal investigator
Name 137938 0
Dr Matthew Fernandez
Address 137938 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 137938 0
Australia
Phone 137938 0
+61 07 3023 4279
Fax 137938 0
Email 137938 0
m.fernandez@cqu.edu.au
Contact person for public queries
Name 137939 0
Matthew Fernandez
Address 137939 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 137939 0
Australia
Phone 137939 0
+61 07 3023 4279
Fax 137939 0
Email 137939 0
m.fernandez@cqu.edu.au
Contact person for scientific queries
Name 137940 0
Matthew Fernandez
Address 137940 0
CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
Country 137940 0
Australia
Phone 137940 0
+61 07 3023 4279
Fax 137940 0
Email 137940 0
m.fernandez@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
Feasibility trials like this one proposed will have a small sample size and focus on determining whether a study design is workable, rather than providing robust conclusions about efficacy. Thus, the benefits of IPD sharing will be limited in this context.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24314Study protocol    Protocol 388720-(Uploaded-16-12-2024-16-39-54)-CQU Ethics Protocol.docx



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.