Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000263594
Ethics application status
Approved
Date submitted
9/02/2024
Date registered
15/03/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and acceptability of a swimming and education program for low back pain
Scientific title
Effectiveness and acceptability of a swimming and education program for adults with chronic low back pain: a randomised controlled trial
Secondary ID [1] 311171 0
Nil
Universal Trial Number (UTN)
U1111-1301-7166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 332348 0
Condition category
Condition code
Musculoskeletal 329058 329058 0 0
Other muscular and skeletal disorders
Public Health 329715 329715 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Swimming and education program for low back pain
Procedures:
A total of four physiotherapy sessions will be completed over telehealth. The initial session will last approximately 45 minutes. The three follow up sessions will be approximately 20 minutes each, occurring at approximately 1 week, 3 weeks, and 7 weeks after the first consultation.
In the initial session the participant will be introduced to the swimming program and education on low back pain. The swimming program intensity, frequency and duration will be based on the participant’s current swimming ability and fitness and a general goal to achieve 3 swimming sessions of 30-45 minutes per week by the 8th week. There are no limitations on the minimum or maximum dosage. The final dose will be agreed upon between the participants and the physiotherapist.
The following three telehealth sessions will be used to help progress the swimming program, overcome barriers and provide education on a modern understanding of low back pain.
Access to a local swimming pool will be provided to the participants, free of cost.
Health coaching will be provided to assist participants with identifying and overcoming barriers to completing the program.
Who provides:
A physiotherapist with a minimum 2 years of clinical experience and who has training in health coaching.
Tailoring:
The swimming program will be tailored to participant goals, current swimming capacity and participant preferences.
Adherence:
Adherence to the participant's swimming program will be assessed at each physiotherapy session and health coaching techniques will be used to identify barriers and facilitate adherence to the program.
A written diary will be used to record swimming progress.
Intervention code [1] 327619 0
Treatment: Other
Comparator / control treatment
Name: Back pain education
Materials:
Back pain education delivered over telehealth during one initial session, and a second optional session for participants who request it. The education will be based on the Australian Low Back Pain Clinical Care Standards for a modern understanding of low back pain. The following 3 key messages will be emphasised: Pain is an alarm for the body (and does not always equal harm); the back is made for movement; flare-ups are common and the best management is keeping moving.
Participants in the control group will be renumerated for their time with e-gift vouchers valued at $15 per follow-up survey.
Procedures:
An initial telehealth session of approximately 15 minutes, straight after randomization, where the education will be provided.
A second follow up telehealth session will be available to participants 2 weeks after baseline, if they indicate that they require it.
Who provides:
A physiotherapist with a minimum 2 years of clinical experience
Tailoring:
The education will be tailored to each participant, based on their current understanding and beliefs about back pain. The information will be provided in a conversational environment, where participants will be able to discuss how the education applies to their own lives.
Adherence:
The number of participants who request a second education telehealth session will be counted.
Control group
Active

Outcomes
Primary outcome [1] 336862 0
Function related to back pain
Timepoint [1] 336862 0
8 weeks after randomisation
Secondary outcome [1] 429920 0
Function related to back pain
Timepoint [1] 429920 0
Baseline, and 3 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [2] 429921 0
Function related to back pain
Timepoint [2] 429921 0
Baseline, 3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [3] 429922 0
Physical activity
Timepoint [3] 429922 0
Baseline, 8 weeks and 26 weeks after randomisation
Secondary outcome [4] 429943 0
Low back pain
Timepoint [4] 429943 0
Baseline, 3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [5] 429944 0
Analgesic use
Timepoint [5] 429944 0
Baseline, 13 weeks and 26 weeks after randomisation
Secondary outcome [6] 429945 0
Healthcare services used for low back pain
Timepoint [6] 429945 0
Baseline, and 13 weeks and 26 weeks after randomisation
Secondary outcome [7] 429946 0
Pain self-efficacy
Timepoint [7] 429946 0
Baseline, and 3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [8] 429947 0
Fear-avoidance beliefs
Timepoint [8] 429947 0
Baseline, and 3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [9] 429948 0
Patient-perceived global improvement
Timepoint [9] 429948 0
3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [10] 429949 0
Adverse events (for example, flare up of low back pain, shoulder pain, other injury from exercising or medical events)
Timepoint [10] 429949 0
3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [11] 429983 0
Swimming completed during the intervention period
Timepoint [11] 429983 0
8 weeks and 26 weeks after randomisation
Secondary outcome [12] 429984 0
Adherence to swimming program (intervention group only)
Timepoint [12] 429984 0
3 weeks, 8 weeks, 13 weeks and 26 weeks after randomisation
Secondary outcome [13] 429985 0
Patient satisfaction with treatment
Timepoint [13] 429985 0
8 weeks and 26 weeks after randomisation
Secondary outcome [14] 429986 0
Participant intention to continue swimming
Timepoint [14] 429986 0
26 weeks after randomisation

Eligibility
Key inclusion criteria
Adult participants will need to fulfil the following:
A current episode of non-specific low back pain, lasting at least 12 weeks, 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 3/10 average pain in the last 7 days on the Numeric Pain Rating Scale.
Able to swim 25 metres and report confidence in water competency (as defined by The Red Cross Water Competency).
Willing and able to complete a swimming program.
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/swim 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 or given birth in the last 3 months.
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).
Currently achieving more than 150 min of moderate or vigorous intensity physical activity weekly (across a minimum of 3 days/week).
Participation in regular swimming (not including hydrotherapy) in the last 12 months (completing >2 sessions per month, more than 50m at a time).
Currently experiencing a musculoskeletal condition of the lower or upper limb that would limit their ability to swim.
Insufficient English to comprehend study questions and instructions.

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 either the treatment group of control (education) group using the REDCap randomisation module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer generated by a researcher not involved in the recruitment or follow-up and uploaded into REDCap to maintain allocation concealment. Randomisation will use randomly permuted blocks of 4 and 6 and stratified by Rolland Morris Disability Questionnaire results (above and below 7/24) and swimming history (On average, how many days have you swum per month in the last year? (swimming classified as at least 100m) 0/1 or more).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will follow intention-to-treat principles. Repeated-measures linear mixed models will be used to assess the effect of treatment on pain-related physical activity limitation across all time points (3, 8, 13 and 26 weeks), with the primary comparison between groups at 8 weeks. All continuous secondary outcomes will be evaluated using equivalent linear mixed models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
4/04/2024
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
29/01/2026
Actual
Sample size
Target
74
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315427 0
University
Name [1] 315427 0
Macquarie University
Country [1] 315427 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 317494 0
None
Name [1] 317494 0
Address [1] 317494 0
Country [1] 317494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314340 0
Macquarie University Human Research Ethics Committee (medical sciences)
Ethics committee address [1] 314340 0
Ethics committee country [1] 314340 0
Australia
Date submitted for ethics approval [1] 314340 0
20/11/2023
Approval date [1] 314340 0
18/01/2024
Ethics approval number [1] 314340 0
520231643354541

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

Contacts
Principal investigator
Name 131242 0
Prof Mark Hancock
Address 131242 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 131242 0
Australia
Phone 131242 0
+61 2 98506622
Fax 131242 0
Email 131242 0
[email protected]
Contact person for public queries
Name 131243 0
Mark Hancock
Address 131243 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 131243 0
Australia
Phone 131243 0
+61 2 98506622
Fax 131243 0
Email 131243 0
[email protected]
Contact person for scientific queries
Name 131244 0
Mark Hancock
Address 131244 0
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
Country 131244 0
Australia
Phone 131244 0
+61 2 98506622
Fax 131244 0
Email 131244 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 December 2025. 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.