Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001012662
Ethics application status
Approved
Date submitted
1/09/2023
Date registered
19/09/2023
Date last updated
25/08/2024
Date data sharing statement initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain during and after different swim strokes in people with chronic low back pain
Scientific title
Pain during and after different swim strokes in people with chronic low back pain: a crossover study design
Secondary ID [1] 309885 0
None
Universal Trial Number (UTN)
U1111-1295-7960
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 330862 0
Condition category
Condition code
Musculoskeletal 327661 327661 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will compare the pain experience of three different swimming styles (freestyle, breaststroke and backstroke) in participants with chronic low back pain. Each participant will complete one swimming session, including 3 sets of 100m swimming (one for freestyle, breaststroke and backstroke) in a random order, totalling to 300m of swimming. Each session will be supervised one on one by a physiotherapist, and will be completed in a public pool that is under lifeguard supervision.
While swimming, participants will be allowed short rest breaks after ever 25m, if required. Participants will complete a 10-minute break between each swim stroke, and a 50m walking warm up before commencing each swim stroke. This will be completed in a one-off session in a lifeguard supervised indoor heated 25m pool.
Notes will be taken to record any deviations from the prescribed swimming strokes, for example if a participant fails to complete 100m of a specific swim stroke.
Intervention code [1] 326591 0
Treatment: Other
Comparator / control treatment
Patient acts as their own control. Each swim stroke (e.g. freestyle, breaststroke and backstroke) will be compared to each other.
Control group
Active

Outcomes
Primary outcome [1] 335466 0
Average pain experienced during each swimming exposure, assessed using the numerical pain rating scale (0-10).
Timepoint [1] 335466 0
Collected immediately after each swimming stroke trial.
Primary outcome [2] 336045 0
Worst pain experienced during each swimming exposure, assessed using the numerical pain rating scale (0-10).
Timepoint [2] 336045 0
Collected immediately after each swimming stroke trial.
Secondary outcome [1] 424740 0
Standing pain (0-10, Numeric Pain Rating Scale).
Timepoint [1] 424740 0
Collected immediately after each swimming stroke trial.
Secondary outcome [2] 424741 0
Pain with active movement of the low back in direction of aggravating movement (0-10, Numeric Pain Rating Scale). This is the movement that was assessed to produce an increase of at least 1/10 pain during screening. The direction of the movement will be recorded. If multiple movements produced pain we will select in the following order: flexion first, extension second and rotation third.
Timepoint [2] 424741 0
Collected immediately after each swimming stroke trial.
Secondary outcome [3] 424742 0
Physiological response (Average heart rate in last 50m).
Timepoint [3] 424742 0
Collected during each swimming trial using the Polar OH1 Heart rate monitor.
Secondary outcome [4] 424743 0
Exertion measure (Borg RPE, 6-20) during the swimming exposure.
Timepoint [4] 424743 0
Collected immediately after each swimming stroke trial.
Secondary outcome [5] 424745 0
Self-rated swim stroke preference (freestyle, breaststroke or backstroke). Collected using a study-specific questionnaire.
Timepoint [5] 424745 0
Collected after completing all three swimming trials.
Secondary outcome [6] 426617 0
Peak sagittal axis acceleration at the thorax in the last 50m.
Timepoint [6] 426617 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the thoracic region during each swimming trial.
Secondary outcome [7] 426618 0
Peak frontal axis acceleration at the thorax in the last 50m.
Timepoint [7] 426618 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the thoracic region during each swimming trial.
Secondary outcome [8] 426619 0
Peak longitudinal axis acceleration at the thorax in the last 50m.
Timepoint [8] 426619 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the thoracic region during each swimming trial.
Secondary outcome [9] 426620 0
Peak sagittal axis acceleration at the sacrum in the last 50m.
Timepoint [9] 426620 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the sacral region during each swimming trial.
Secondary outcome [10] 426621 0
Peak frontal axis acceleration at the sacrum in the last 50m.
Timepoint [10] 426621 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the sacral region during each swimming trial.
Secondary outcome [11] 426622 0
Peak longitudinal axis acceleration at the sacrum in the last 50m.
Timepoint [11] 426622 0
Collected using the Blue Trident Inertial Measurement Unit, attached to the sacral region during each swimming trial.

Eligibility
Key inclusion criteria
Adult participants will need to meet the following criteria:
A current episode of non-specific low back pain, lasting at least 3 months, with or without leg pain.
Experiencing at least some disability due to low back pain (defined as “a little bit” and above on an adapted item 22 of the SF-36).
A minimum of 2/10 average pain in the last 7 days on the Numeric Pain Rating Scale.
Experiences an increase of low back pain (>1 point on NPRS) with active lumbar flexion, extension, or rotation.
Able to confidently swim 100 m using freestyle, breaststroke, and backstroke. This can include taking short breaks after 25 meters if required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they meet the following:
Have been diagnosed with a medical condition that could impact their ability to exercise safely unless they have been cleared to exercise by their General Practitioner.
Have a serious spinal pathology such as cancer, fracture, or infection.
Are pregnant.
Insufficient English to comprehend study questions and instructions.
Presence of radicular pain (dermatomal pain extending below the knee, which is more intense than the low back pain) or radiculopathy (loss of power, sensation, or reflexes in the lower extremity)

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)
Participants will be randomly allocated to one of 6 different sequences for their experimental testing session using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software will randomise participants to 1 of 6 sequences. The sequences will be generate using a balance Latin square technique which creates 6 independent orders of freestyle, backstroke, and breaststroke. The person generating the sequence will not be involved in randomising patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 30 was determined to provide 80% power to detect a standardised mean difference of 0.25 in pain response during swimming (primary outcome) between the different strokes.
Primary and secondary outcomes will be compared across strokes (freestyle, breaststroke, and backstroke) using a mixed model that includes a fixed effect of stroke type and a random effect of participant. Baseline pain will be considered as a covariate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2023
Actual
11/10/2023
Date of last participant enrolment
Anticipated
15/12/2023
Actual
23/02/2024
Date of last data collection
Anticipated
19/01/2024
Actual
23/02/2024
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40941 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 314069 0
University
Name [1] 314069 0
Macquarie University
Country [1] 314069 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 316765 0
None
Name [1] 316765 0
Address [1] 316765 0
Country [1] 316765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313209 0
Macquarie University Human Research Ethics Committee (medical sciences)
Ethics committee address [1] 313209 0
Ethics committee country [1] 313209 0
Australia
Date submitted for ethics approval [1] 313209 0
16/06/2023
Approval date [1] 313209 0
17/08/2023
Ethics approval number [1] 313209 0
520231544152335

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

Contacts
Principal investigator
Name 127346 0
Prof Mark Hancock
Address 127346 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 127346 0
Australia
Phone 127346 0
+61 2 98506622
Fax 127346 0
Email 127346 0
[email protected]
Contact person for public queries
Name 127347 0
Mark Hancock
Address 127347 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 127347 0
Australia
Phone 127347 0
+61 2 98506622
Fax 127347 0
Email 127347 0
[email protected]
Contact person for scientific queries
Name 127348 0
Mark Hancock
Address 127348 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 127348 0
Australia
Phone 127348 0
+61 2 98506622
Fax 127348 0
Email 127348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data for all outcome measures will be available as de-identified data.
Meta-data will accompany this data set.
When will data be available (start and end dates)?
Data will be available after the results have been disseminated in a peer-reviewed journal. This is anticipated to be around August 2024. There is no end date.
Available to whom?
Access to this data will be conditional on approval from Professor Mark Hancock and ethical approval is provided. Professor Mark Hancock will be contactable at the following address and email:
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
[email protected]
Available for what types of analyses?
Any purpose, as long as the data is deemed suitable to answer a specific research question and ethical approval is provided.
How or where can data be obtained?
Data will be available on the Macquarie Research Data Repository.
Queries concerning the IPD may be directed to Professor Mark Hancock, who will be contactable at the following address and email:
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
[email protected]


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.