Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000624583
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
14/05/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of resistance training on pain, well-being, and inflammation in chronic low back pain
Scientific title
Effects of resistance training on pain, well-being, and inflammation in chronic low back pain
Secondary ID [1] 311636 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 333078 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329766 329766 0 0
Physiotherapy
Musculoskeletal 330330 330330 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a 12-week supervised resistance training program. Across this time, they will attend two group-based (3-4 participants) 60-minute face-to-face resistance training sessions per week (24 total sessions), prescribed and supervised by a qualified physiotherapist from the research group. Before the start of the intervention, a physical assessment (health history; lower back assessment and blood pressure) will be conducted by the physiotherapist. Resistance training sessions will be individualised based on the participant’s muscle strength. After learning the correct technique of each exercise, muscle strength will be determined by a series of submaximal strength tests in week three to determine the required training intensity. Resistance training sessions will consist of a ten-minute general warm up, including dynamic exercises for the trunk, legs, and shoulders. After warm-up, participants will perform 3 sets and 8-12 repetitions of the following resistance exercises with a barbell and weights: squat (1), barbell row (2), deadlift (3), and bench press (4). The selection of exercises is based on a prior study with a similar population and was considered safe. The training intensity will initially be 50% of the maximal strength (adaptation phase) and will gradually increase by 10% every 3 weeks, which is informed by previous studies. Adherence to the resistance training sessions will be assessed by documenting the overall training session attendance, within-session training load completed and rate of perceived exertion (RPE) for each training session.
Intervention code [1] 328095 0
Treatment: Other
Comparator / control treatment
Participants will be asked to manage their low back pain as usual (e.g. GP management, over-the-counter pharmacotherapy). No intervention will be provided during the 12-week follow-up. Following completion of the study, participants will be offered a consultation with a qualified physiotherapist from the research group to conduct the same physical assessment (health history; lower back assessment and blood pressure) that the intervention group received to establish an individualised one-off home-based strength training program for the participant. The strength training program will be tailored to the participant's needs and abilities and will include whole-body exercises to improve back pain (e.g., planks, bridging, bird dog).
Control group
Active

Outcomes
Primary outcome [1] 337548 0
Pain intensity
Timepoint [1] 337548 0
Baseline, 6- and 12-week after intervention commencement
Primary outcome [2] 337550 0
Well-being (will be assessed as a composite outcome)
Timepoint [2] 337550 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [1] 432275 0
Disability
Timepoint [1] 432275 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [2] 432276 0
Sleep quality
Timepoint [2] 432276 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [3] 432277 0
Insomnia severity
Timepoint [3] 432277 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [4] 432278 0
Health-related quality of life
Timepoint [4] 432278 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [5] 432287 0
Habitual physical activity
Timepoint [5] 432287 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [6] 432291 0
Healthcare professional and treatment expectations (assessed as a composite outcome)
Timepoint [6] 432291 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [7] 432293 0
Activity specific beliefs
Timepoint [7] 432293 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [8] 432295 0
Kinesiophobia
Timepoint [8] 432295 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [9] 432297 0
Pain catastrophising
Timepoint [9] 432297 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [10] 432298 0
Pain self-efficacy
Timepoint [10] 432298 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [11] 432299 0
Social Support
Timepoint [11] 432299 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [12] 432300 0
Social cohesion
Timepoint [12] 432300 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [13] 432301 0
Social cohesion
Timepoint [13] 432301 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [14] 434208 0
Inflammation
Timepoint [14] 434208 0
Baseline and 12-week after intervention commencement
Secondary outcome [15] 434486 0
Recruitment
Timepoint [15] 434486 0
Upon conclusion of the study
Secondary outcome [16] 434487 0
Attrition
Timepoint [16] 434487 0
Upon conclusion of the study
Secondary outcome [17] 434488 0
Adherence
Timepoint [17] 434488 0
Upon conclusion of the study
Secondary outcome [18] 434489 0
Data collection
Timepoint [18] 434489 0
Upon conclusion of the study
Secondary outcome [19] 434490 0
Safety
Timepoint [19] 434490 0
Every session throughout the 12-week intervention
Secondary outcome [20] 434817 0
Cognitive function (Processing speed)
Timepoint [20] 434817 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [21] 434818 0
Cognitive function (Executive function)
Timepoint [21] 434818 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [22] 434819 0
Cognitive function (Psychomotor speed and visual tracking)
Timepoint [22] 434819 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [23] 434820 0
Cognitive function (Attention, working memory)
Timepoint [23] 434820 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [24] 434821 0
Cognitive function (Visuospatial orientation)
Timepoint [24] 434821 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [25] 434822 0
Cognitive function (Psychomotor speed, vigilant attention)
Timepoint [25] 434822 0
Baseline, 6- and 12-week after intervention commencement
Secondary outcome [26] 434823 0
Cognitive function (Working memory)
Timepoint [26] 434823 0
Baseline, 6- and 12-week after intervention commencement

Eligibility
Key inclusion criteria
(a) adult (aged 18-55 years), (b) has non-specific (no known specific pathology) chronic (12 weeks or longer) low back pain (pain located between the costal margin and above the inferior gluteal folds, with or without leg pain).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) history of spinal surgery, spine trauma (e.g. fracture or car accident), cauda equina symptoms, known structural scoliosis, symptomatic radiculopathy, inflammatory spondyloarthropathies, or non-musculoskeletal causes of low back pain (LBP) (e.g. infection), (b) inability to communicate in English, (c) pregnancy, lactating or <1 year postnatal, (d) any absolute contraindication for exercise training, (e) participation in resistance training or sport that involves resistance training in the last three months (>1 session per month), (f) experienced an injury in the last six weeks.

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)
A team member without contact with participants will obtain and employ the randomisation schedule (creating sequentially numbered, opaque, sealed envelopes).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned (1:1) using block randomisation with random block lengths (between 2 and 6 per block) and stratification for sex to either intervention or control group. The randomisation schedule will be developed using the online software application for randomising participants (https://www.sealedenvelope.com/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Stata (v17, StataCorp, College Station, Texas, United States of America) will be used for all statistical analyses. Normality of the distribution will be assessed by generating histograms and quantile-quantile plots of residuals. Within-group and between-group changes by time on well-being, inflammation and pain intensity will be examined using linear mixed models with random effects, adjusting for variability within participants. A restricted maximum likelihood fit, providing unbiased estimates and an intention-to-treat approach will be applied. An alpha level of 0.05 will be set for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315959 0
University
Name [1] 315959 0
Deakin University
Country [1] 315959 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318105 0
None
Name [1] 318105 0
Address [1] 318105 0
Country [1] 318105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314786 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314786 0
https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
Ethics committee country [1] 314786 0
Australia
Date submitted for ethics approval [1] 314786 0
12/02/2024
Approval date [1] 314786 0
04/03/2024
Ethics approval number [1] 314786 0
2024-044

Summary
Brief summary
A 12-week parallel-group randomised controlled trial examining the effects of a supervised resistance training on pain intensity, well-being, and inflammation compared to usual care in adults with chronic non-specific low back pain will be conducted. It is hypothesised that 12 weeks of resistance training will improve pain intensity, well-being and inflammation compared to usual care in adults with chronic non-specific low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132726 0
A/Prof Luana Main
Address 132726 0
Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
Country 132726 0
Australia
Phone 132726 0
+61 392445030
Fax 132726 0
Email 132726 0
luana.main@deakin.edu.au
Contact person for public queries
Name 132727 0
Luana Main
Address 132727 0
Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
Country 132727 0
Australia
Phone 132727 0
+61 392445030
Fax 132727 0
Email 132727 0
luana.main@deakin.edu.au
Contact person for scientific queries
Name 132728 0
Luana Main
Address 132728 0
Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, 3125 Burwood, Victoria
Country 132728 0
Australia
Phone 132728 0
+61 392445030
Fax 132728 0
Email 132728 0
luana.main@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after deidentification.
When will data be available (start and end dates)?
Immediately after publication. No end date.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (luana.main@deakin.edu.au).


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.