Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000319572
Ethics application status
Approved
Date submitted
20/12/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
My Back Exercise App - A mobile application for people with chronic non-specific low back pain.
Scientific title
My Back Exercise App - An automated exercise intervention supported by educational notifications, a sleep program, and diet advice for people with chronic non-specific low back pain: Adaptive multi-arm multi-stage randomised controlled trial.
Secondary ID [1] 311162 0
Nil known
Universal Trial Number (UTN)
U1111-1301-6286
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain (LBP) 332327 0
Condition category
Condition code
Musculoskeletal 329037 329037 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 329038 329038 0 0
Physiotherapy
Public Health 329039 329039 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This multi-arm multi-stage trial will comprise five study arms, including one control group and four intervention groups. All participants will receive access to the “My Back Exercise” App, with specific access to different intervention components according to the participant’s allocation.
Recruitment and enrolment will commence at the same time for all study arms. After enrolment and completion of the 6-week intervention program by 1/3 of the estimated sample size, an interim analysis will be conducted. The outcome of the interim analysis will allow dropping intervention arms that are deemed futile, in accordance with pre-specified decision rules. There will be no introduction of new arms into the study. The overall duration of the study is one year after randomisation.

Study Arms:
- Intervention Group 1: Education + Notifications + Exercise.
- Intervention Group 2: Education + Notifications + Exercise + Sleep.
- Intervention Group 3: Education + Notifications + Exercise + Diet.
- Intervention Group 4: Education + Notifications + Exercise + Sleep + Diet.

Intervention Components:

Exercise Module:
- Content: A 6-week, automated, home-based, tailored exercise program, generated based on the participant’s self-reported functional level, as measured by a modified version of the Patient-Specific Functional Scale (PSFS). The exercise program will include up to three exercises and three additional options for swapping. Each week, three new exercises will replace previous ones. The dosage of the resistance training according to difficulty level was established based on the American College of Sports Medicine (ACSM) ) and the International Exercise Recommendations in Older Adults. A total of 8-12 repetitions will be recommended for isotonic exercises and 10-30 seconds hold for isometric exercises; three sets; three times a week; at an exercise intensity of 7-9 in all programs, as rated on the 11-point scale of Rating of Perceived Exertion (RPE). A graded approach to progression in intensity and complexity of the exercises will be adopted.
The content of the exercise module has been designed specifically for this study and includes strengthening and flexibility exercises. The exercises will involve bodyweight only, and some of them may require minimal equipment (e.g., a mat, chair, table, step, pillow, handrail or wall for support). Examples of strengthening exercises include planks, squats, lunges, push-ups, and curl-ups. Examples of flexibility exercises include trunk, hamstrings, piriformis, and quadriceps stretching.
- Frequency and Duration: Participants will be recommended to complete their exercise program at least three days per week across the 6-week exercise program, totalling 18 exercise sessions. There will be no distinction among intervention groups. Considering that the exercise program should be performed three times a week and each exercise session should take approximately 20 to 30 minutes, completing the exercise module should take approximately 60 to 90 minutes per week for 6 weeks.

Education Module:
- Content: A 6-week intervention containing written information, audio tracks, and links to online resources providing information about the nature of non-specific LBP, symptoms, evidence-based treatments, pain management, frequently asked questions about LBP, and guidance to assist participants in increasing their physical activity level. The content of the educational module has been designed specifically for this study and is complemented with links to additional, online, readily available resources (e.g., Australian Government - Health Direct, Australia Physiotherapy Association, Musculoskeletal Australia, and scientific references).
- Frequency and Duration: Every week, new content will be made available (i.e., unlocked) and participants will be recommended to complete the weekly content at their convenience. Completing the education module should take approximately 10 to 30 minutes per week for 6 weeks.

Sleep Module:
- Content: A 4-week tailored sleep education program containing written information, audio tracks, and links to online resources providing information about sleeping habits, sleep efficiency, how sleep and LBP are connected, and how to optimise sleep and improve overall well-being. Participants will be given hints, tips and personalised goals on how to improve their sleeping habits through relaxation training and stimulus control. The content of the sleep module has been designed specifically for this study with advice from researchers in the sleep field.
- Frequency and Duration: Once a week, participants will be asked to review sleep information and choose a goal for the week. This should take approximately 5 minutes. Once a day, participants will be sent a reminder to work on their goal. This should take approximately 2 to 10 minutes depending on the goal they choose. Completing the sleep module should take approximately 10 to 15 minutes per week for 4 weeks.

Diet Module:
- Content: A 6-week intervention containing written information, audio tracks, and links to online resources providing information about the basics of nutrition, including food groups, ultra-processed foods, the impact of sugar on health, the role of antioxidants, and how to integrate suitable nutrition into the lifestyle and boost their overall well-being. Participants will be offered weekly tasks on how to read nutrition labels, make healthier food choices, and use food as a coping strategy to self-manage their chronic pain.
The content of the diet module has been designed specifically for this study and is complemented with links to additional, online, readily available resources (e.g., Australian Government - Eat for Health / Eating Well, NSW Government - Food Authority, and scientific references). The content is strictly educational, encouraging participants to adopt healthier eating habits. No recommendations will be made regarding specific diets, and no meal plans or recipes to follow will be provided.
- Frequency and Duration: Every week, new content will be made available (i.e., unlocked) and participants will be recommended to complete the weekly content at their convenience. Completing the diet module should take approximately 10 to 30 minutes per week for 6 weeks.

Automated Push Notifications:
- Content: Participants will receive lifestyle-based self-management push notifications providing encouragement, advice, and motivation, as well as information about LBP, and tips about exercise, physical activity, sleep, diet, mood, and use of care and medication. Each notification will be approximately 160 characters in length and will include the name of the App. The content of the push notifications has been adapted from a previous study (TEXT4myBACK; ACTRN12618001263280), where a bank of text messages was developed for people with LBP.
- Frequency and Duration: Participants will receive up to 4 notifications per week for 6 weeks in random time slots at 9 am, 12:30 pm, 4 pm, and 6 pm. There will be no distinction among intervention groups.

Strategies to Monitor Adherence:
To measure adherence to the exercise and sleep modules (which offer tailored content), participants will be prompted to complete a self-reported activity tracker within the My Back Exercise App. To measure adherence to the education and diet modules, participants will be prompted to complete an electronic logbook through REDCap weekly. Additionally, there will be a brief interview/survey by email or phone call at 6 and 9 months after randomisation to follow-up adherence and engagement with the app.
Adherence will be calculated for each study arm and the entire study considering the self-reported number of completed exercise sessions expressed as a proportion of the total prescribed exercise sessions. Adherence will be considered acceptable when participants complete at least 70% of their prescribed exercise program.
Intervention code [1] 327602 0
Treatment: Other
Intervention code [2] 327603 0
Rehabilitation
Intervention code [3] 327604 0
Lifestyle
Comparator / control treatment
Participants allocated to the control group will receive access to the My Back Exercise App, including only the Education Module.
Control group
Active

Outcomes
Primary outcome [1] 336851 0
Physical function
Timepoint [1] 336851 0
Baseline, 6, 12, and 52 weeks after randomisation.

The primary timepoint is 6 weeks after randomisation (i.e., immediate post-intervention), while the secondary timepoints are 12 and 52 weeks after randomisation.
Secondary outcome [1] 429870 0
Pain intensity - Average pain intensity in the last 24 hours
Timepoint [1] 429870 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [2] 429871 0
Pain frequency
Timepoint [2] 429871 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [3] 429872 0
Disability
Timepoint [3] 429872 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [4] 429873 0
Health-related quality of life
Timepoint [4] 429873 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [5] 429874 0
Exercise self-efficacy
Timepoint [5] 429874 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [6] 429875 0
Adherence to exercise recommendations
Timepoint [6] 429875 0
6 weeks after randomisation
Secondary outcome [7] 429876 0
Global perceived effect
Timepoint [7] 429876 0
6, 12, and 52 weeks after randomisation
Secondary outcome [8] 429877 0
Sleep quality
Timepoint [8] 429877 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [9] 429878 0
Health literacy level
Timepoint [9] 429878 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [10] 429879 0
Overall satisfaction
Timepoint [10] 429879 0
6 weeks after randomisation
Secondary outcome [11] 429880 0
Rate of completed follow-up
Timepoint [11] 429880 0
6, 12, and 52 weeks after randomisation
Secondary outcome [12] 429881 0
Recruitment rate
Timepoint [12] 429881 0
6 weeks after randomisation
Secondary outcome [13] 429882 0
Conversion rate
Timepoint [13] 429882 0
Baseline
Secondary outcome [14] 429883 0
Usefulness of the My Back Exercise App (overall)
Timepoint [14] 429883 0
6 and 52 weeks after randomisation
Secondary outcome [15] 429884 0
Frequency of the push notifications (intervention groups, only)
Timepoint [15] 429884 0
6 and 52 weeks after randomisation
Secondary outcome [16] 429886 0
Exercises importance
Timepoint [16] 429886 0
Baseline and 6 weeks after randomisation
Secondary outcome [17] 429887 0
Co-interventions use
Timepoint [17] 429887 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [18] 429888 0
Consumption of highly processed food
Timepoint [18] 429888 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [19] 429889 0
Impression of change
Timepoint [19] 429889 0
6, 12, and 52 weeks after randomisation
Secondary outcome [20] 429890 0
Adverse events
Timepoint [20] 429890 0
2, 4, 6, and 52 weeks after randomisation
Secondary outcome [21] 430746 0
Pain intensity - Average pain intensity in the preceding week
Timepoint [21] 430746 0
Baseline, 6, 12, and 52 weeks after randomisation
Secondary outcome [22] 430747 0
Usefulness of each module of the My Back Exercise App
Timepoint [22] 430747 0
6 and 52 weeks after randomisation

Eligibility
Key inclusion criteria
i. Aged 18 years or older.
ii. Report an episode of non-specific LBP of at least 12 weeks duration, with or without leg pain. LBP is defined as pain on the posterior aspect of the body from the lower margin of the twelfth ribs to the lower gluteal folds, with or without referred pain in one or both lower limbs (74). Non-specific LBP is defined as LBP without a diagnosis of a specific cause, and the absence of serious spinal pathology or indicators of potentially serious conditions using ‘red’ flags.
iii. Had the low back pain diagnosed by a healthcare practitioner within the last 24 months.
iv. Have a smartphone or tablet with an Internet connection.
v. Have independent mobility and eyesight to see the app content and exercise independently and safely.
vi. Have a sufficient understanding of English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Known or suspected serious spinal pathology (e.g., fracture, inflammatory disorder); specific diagnosis of LBP (e.g., sciatica, spinal stenosis grade 3 to 4); self-reported radicular symptoms (e.g., reflex changes, motor loss).
ii. Spinal surgery in the past 12 months.
iii. LBP caused by involvement in a road traffic crash in the last 12 months or currently receiving ongoing litigation.
iv. Fibromyalgia or systemic/inflammatory condition(s) that are not controlled (e.g., systemic lupus erythematosus, multiple sclerosis).
v. Co-morbid health condition(s) diagnosed by a medical practitioner that would prevent participation in physical activity or exercise programs (e.g., chronic heart conditions).
vi. Fail pre-exercise screening, where participants must declare they have medical clearance to participate in an unsupervised home exercise program.
vii. Regular use of mobility aids.

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)
To conceal allocation, the randomisation schedule will be generated via a computer, password-protected software by a researcher not involved in participant recruitment scheduling or assessment. The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware when this decision is made, to which group the participant will be allocated. Participants will be notified of their allocation via email from an unblinded research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation will be prepared in permuted blocks of sizes 10 to 15. The randomisation schedule will be generated via a computer, password-protected software by a researcher not involved in participant recruitment scheduling or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Multi-arm multi-stage design (adaptive)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted following the intention-to-treat principle. Baseline characteristics will be summarised by arm using descriptive statistics and reported with measures of frequency (proportion), mean, standard deviation (SD) and 95% confidence interval (95% CI). Differences in dichotomous variables will be expressed as risk difference (RD) and number needed to treat (NNT) or number needed to harm (NNH) with 95% CI. Continuous variables will be summarised and reported with mean and SD in case of a Gaussian (normal) distribution or as the median and interquartile range (IQR) in case of a skewed distribution.
At the interim and final analysis, differences in outcome data between each intervention arm and the control group will be analysed using the Student’s t-test in the case of a Gaussian (normal) distribution. Otherwise, the non-parametric Mann-Whitney U test will be used after correcting for baseline differences, if required. Changes in health-related quality of life scores will be analysed using the Wilcoxon test. The Cox proportional hazards regression modelling will be used to adjust for potential confounding factors. For all analyses, statistical significance will be indicated by a p-value < 0.05.
We plan to run a hypothesis-generating (exploratory) subgroup analysis considering diet and sleep. We will run interaction models to compare the effectiveness of the sleep module in people with low and high scores on the PSQI, as well as the diet module in people with low and high scores on the sQ-HPF.

Interim Analysis:
The interim analysis will be conducted after enrolment and completion of the 6-week intervention program by 1/3 of the estimated sample size. Whether and how the trial will continue will be determined by the outcome of the interim analysis, which will allow for dropping intervention arms that are deemed futile, in accordance with the following pre-specified decision rules considering the primary endpoint (i.e., change in mean PSFS score from baseline to six weeks after randomisation):
1) If the change in an intervention arm is no more than 0.5 points greater than the control group, this intervention arm will be dropped. Under this rule, all four intervention arms may be dropped, and the trial terminated. This decision rule was established based on previous adaptive trials investigating conservative interventions in the field of musculoskeletal health.
2) If the change in one intervention arm is more than 4 points higher than the other, the worst-performing intervention arm will be dropped. This decision rule was established considering the smallest worthwhile effect on disability, reported in previous studies as a 15% incremental improvement beyond the natural recovery. Natural recovery, in turn, is considered a 30% improvement from baseline. Based on a previous study (EMPoweR; ACTRN12618001494224), a 45% improvement from baseline would correspond to a 5.4-point between-group difference. For this study, this effect size was downgraded to 4 points due to the nature and duration of the intervention (i.e., a 6-week digital intervention with no face-to-face interaction).

There will be no introduction of new arms into the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315417 0
University
Name [1] 315417 0
The University of Sydney
Country [1] 315417 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown NSW 2050, Australia.
Country
Australia
Secondary sponsor category [1] 317484 0
None
Name [1] 317484 0
Address [1] 317484 0
Country [1] 317484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314332 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314332 0
The University of Sydney, Western Avenue, Camperdown NSW 2050, Australia.
Ethics committee country [1] 314332 0
Australia
Date submitted for ethics approval [1] 314332 0
28/08/2023
Approval date [1] 314332 0
27/11/2023
Ethics approval number [1] 314332 0
2023/772

Summary
Brief summary
A single-blind, superiority randomised controlled trial encompassing an adaptive multi-arm multi-stage design will be conducted to determine whether the My Back Exercise App is effective for improving self-reported physical function when compared to an app-based standard LBP education for people with chronic non-specific LBP at six weeks after randomisation. Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to either the control group receiving education alone or one of four intervention arms (1: education, notifications, and exercise modules; 2: education, notifications, exercise, and sleep modules; 3: education, notifications, exercise, and diet modules; and 4: education, notifications, exercise, sleep, and diet modules) through the app. The study consists of two stages with the possibility of dropping arms for futility using pre-specified decision rules at the end of the first stage. A total of 370 participants aged 18 years or older, with chronic non-specific LBP, will be recruited Australia-wide from the general community. The primary endpoint will be self-reported physical function, measured by the Patient-Specific Functional Scale (PSFS), at 6 weeks post-randomisation (i.e., immediate post-intervention). If shown to be effective, the My Back Exercise app will be an innovative digital health solution that could facilitate self-management of LBP at scale and in a timely and convenient manner.
Trial website
Trial related presentations / publications
.
Public notes

Contacts
Principal investigator
Name 131214 0
Prof Paulo Ferreira
Address 131214 0
Level 7, Susan Wakil Health Building (D18), The University of Sydney, Western Avenue, Camperdown NSW 2050, Australia.
Country 131214 0
Australia
Phone 131214 0
+61 2 8627 7062
Fax 131214 0
Email 131214 0
paulo.ferreira@sydney.edu.au
Contact person for public queries
Name 131215 0
Mrs Anelise Moreti Cabral Silveira
Address 131215 0
Level 7, Susan Wakil Health Building (D18), The University of Sydney, Western Avenue, Camperdown NSW 2050, Australia.
Country 131215 0
Australia
Phone 131215 0
+61 450 175 572
Fax 131215 0
Email 131215 0
amor0266@uni.sydney.edu.au
Contact person for scientific queries
Name 131216 0
Prof Paulo Ferreira
Address 131216 0
Level 7, Susan Wakil Health Building (D18), The University of Sydney, Western Avenue, Camperdown NSW 2050, Australia.
Country 131216 0
Australia
Phone 131216 0
+61 2 8627 7062
Fax 131216 0
Email 131216 0
paulo.ferreira@sydney.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


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.