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Trial registered on ANZCTR


Registration number
ACTRN12618001263280
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
26/07/2018
Date last updated
18/03/2020
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TEXT4myBACK’ text message intervention to improve function in people with low back pain
Scientific title
TEXT4myBACK’ text message intervention to improve function in people with low back pain
Secondary ID [1] 294765 0
Nil Known
Universal Trial Number (UTN)
U1111-1217-6137
Trial acronym
TEXT 4 my BACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 307667 0
Condition category
Condition code
Musculoskeletal 306733 306733 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention will receive semi-personalised text messages providing advice, motivation and information to improve education, physical activity, sleep, mood, use or care and medication. 'Semi-personalised' relates to the use of the participants chosen contact name for the welcome to the study message, end of study thank you message and some of the advise, motivation and information messages were the character count allows for the addition of their name. This has been previously shown to increase the participants' engagement with the messages received. The messages will be further personalised based on the duration of symptoms, sleep issues, physical activity levels, reporting taking medication for the back pain at baseline, and having a sedentary job.

Participants will receive 4 text messages every week for 12 weeks. The messages will be sent on random days of the week, including weekends but excluding public holidays. The time of day the messages will be randomly selected from 4 slots: 9am, 12.30pm, 4 pm and 6 pm. Participants will be eligible to receive all messages regardless of content as they will be evidence-based and generic in nature. The content of the message will be selected using an algorithm derived from key domains of the study (physical activity, education, sleep, mood, use or care and medication). The text message delivery will be managed by the ‘TEXT me’ software program through the University of Sydney and is designed to be delivered one-way (to the participant only).

Participants will not be monitored for adherence to reading or opening the text messages, however, they will have the ability to reply to the messages with "STOP" if they wish to discontinue receiving the messages. The system is designed be one-way (to the participant only), however all return messages will be monitored for any return messages alluding to the participants health and safety.

Change in participant behaviour as a result of the messages will be based on the changes in the health outcome measures used (pain levels, patient specific function, physical and sedentary activity levels, quality of life and use of care).

This change was made prior to enrolment commencement.
Intervention code [1] 301066 0
Lifestyle
Comparator / control treatment
Participants randomised to the minimal intervention group will receive 3 text messages, one to welcome them to the trial, one to send them a link to online low back pain information material and one that will inform them that they will be contacted 3,6 and 12 months for the completion of the online outcome questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 305727 0
Patient-specific functional scale. This is a condition-specific measure used to quantify activity limitation and function in patients with musculoskeletal pain. The participant will be asked to identify three important activities that they are unable to do or are having difficulty with as a result of their LBP. They will rate each activity using a numerical rating scale of 0-10 (0 meaning unable to perform activity and 10 meaning able to perform activity to the same level as before the injury or/problem). This will take approximately 2 minutes to complete.
This is a validated measure that has not been specifically designed for the study.
Timepoint [1] 305727 0
All measures will be taken at baseline, 3 months (primary end-point), 6 months and 12 months after randomisation
Secondary outcome [1] 346288 0
Physical activity engagement (Active Australia Questionnaire).
Timepoint [1] 346288 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [2] 346289 0
Sedentary Behaviour (Sedentary Behaviour Questionnaire).
Timepoint [2] 346289 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [3] 346290 0
Participant’s global impression of change (Global Change).
Timepoint [3] 346290 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [4] 346292 0
Health related quality of life will be now measured with the EQ-5D-5L questionnaire. This is a validated questionnaire used to describe and value individual’s health. It assesses 5 components of quality of life: mobility, self-care, usual activities, pain and emotional health. It also rates the individuals perception of their overall health on a scale of 0 (worst health) to 100 (best health). It offers five response levels to each question (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems) and its clinical use has been recommended within musculoskeletal populations
Timepoint [4] 346292 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [5] 346293 0
Health care utilisation (via MBS/PBS and diary)
Timepoint [5] 346293 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [6] 377304 0
Average pain intensity during past week. This will be a self-reported measure using a single question to rate the participant’s average pain of the preceding 7 days. It uses a sliding scale 0-100 (0 meaning no pain and 100 meaning worst pain possible) and relies on the patient’s memory of the actual pain severity experienced. It is considered to be responsive to change, easy to understand and complete and will take less than a minute to complete
Timepoint [6] 377304 0
All measures will be taken at baseline, 3 months, 6 months and 12 months after randomisation.
Secondary outcome [7] 377305 0
Health Education Impact Questionnaire.
This is a validated online questionnaire to assess patients’ health literacy gaining a broad profile of patients’ education on health and self-management strategies. The questionnaire consists of 7 different domains, which have four to six questions each
Timepoint [7] 377305 0
Baseline, 3, 6 and 12 months
Secondary outcome [8] 380241 0
Smallest worthwhile change assessed as presented below along with a visual analogue scale will be presented, and it will range from 0 (unable to perform activities) to 30 (able to perform activities at the same level as before the current low back pain episode).

Self-management may include recommendations to remain active, read educational material or apply superficial heat. There is usually no cost involved in self-management and there is some time commitment depending on the time needed to read the information and follow the recommendations.

Based on your current score of [sum_function]/30 points, please place the slider below on the SMALLEST (lowest) function score you would need to reach at the end of this self-management intervention to consider it worthwhile.

* Please note that the SMALLEST (lowest) score should be equal or greater than your current score.
Timepoint [8] 380241 0
baseline
Secondary outcome [9] 380762 0
Feedback from participants from the intervention group
Timepoint [9] 380762 0
52 weeks

Eligibility
Key inclusion criteria
Aged 18 years or older.
• Have an episode of non-specific LBP of less than 12 weeks duration, with or without the presence of leg pain
• Have pain classed as ‘moderate’ or above in the pain scale of the SF-12
• Familiarity with the use and access to, a phone that can receive text messages
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of serious pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder)
• Current pregnancy
• Spinal surgery within the preceding 12 months
• Co-morbid health conditions that would prevent active participation in the physical activity programs (e.g. unstable angina, uncontrolled hypertension)
• Inadequate English to understand the text messages or complete outcome measures
• Any disorder/reason that may reduce capacity to understand and give informed
consent

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Sample size calculation was based on the between-group difference at the primary endpoint (3 months), on our primary outcome, i.e. patient-specific function scale (0-30 points). In our previous study of physical activity and exercises for LBP, the within-group change on physical function was normally distributed with a standard deviation of 7. A sample size of 152 per group (total of 304 participants) will achieve 90% power to detect an effect size of 0.4 SD on physical function, allowing for a loss to follow-up rate of 15% at 3 months.

All analyses will be blinded to group status and will be by intention-to-treat. Statistical significance will be defined as P<0.05 on the basis of a two-sided test. The primary outcome will be analysed using a Student T-test. Analysis adjusted for baseline scores and other demographic and clinical characteristics will also be performed using analysis of covariance models with the change from baseline as the dependent variable. A secondary analysis including data from all follow-ups and will be conducted using repeated measures with GEE (generalized estimating equations). The coefficient of the group x time interactions will provide estimates of treatment effects over time. The remaining outcome measures will also be regarded as secondary and analysed separately with log-binomial regression for dichotomous measures and linear regression analysis for continuous outcomes.

Baseline demographic data and the distribution of the smallest worthwhile change (SWC) of participants of both groups will be presented by central tendency and variability. Missing data or drop-outs will not be included in the analyses and data from the sample will not be imputed, as they would not represent individualised values.
Age, symptom duration, pain intensity, presence of leg pain, function, and health literacy were identified a priori as potential predictors of the SWC. Multivariate linear regression analyses will be used to quantify the associations between the magnitude of the SWC and predictors; and 95% confidence intervals will be calculated to assess precision of the results.
The percentage of participants meeting the SWC will be calculated for both groups at 12 weeks by dividing the number of participants who achieved the SWC by the total of participants with a SWC score from the group. The odds ratio and the 95% confidence interval will be calculated for each group as well as for the difference between groups. In addition, the number needed to treat (NNT) with self-management intervention so that one participant achieves the SWC will also be calculated (NNT = 1/ % participants from Intervention Group achieving the SWC - % participants from Control Group achieving the SWC). Furthermore, multivariate linear regression analyses will be used to quantify the associations between achieving the SWC and the 95% confidence intervals will be calculated to assess certainty of the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 23477 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 299369 0
Charities/Societies/Foundations
Name [1] 299369 0
Musculoskeletal Australia
Address [1] 299369 0
263 Kooyong Rd, Elsternwick VIC 3185
Country [1] 299369 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Institute of Bone and Joint Research,
Level 10, The Kolling Institute,
Royal North Shore Hospital,
Reserve Road
St Leonards, NSW 2065,
Australia
Country
Australia
Secondary sponsor category [1] 298651 0
None
Name [1] 298651 0
Address [1] 298651 0
Country [1] 298651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300274 0
Northern Sydney Local Health District Human Ethics Committee
Ethics committee address [1] 300274 0
NSLHD Research Office,
Level 13 Kolling Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Ethics committee country [1] 300274 0
Australia
Date submitted for ethics approval [1] 300274 0
18/11/2019
Approval date [1] 300274 0
Ethics approval number [1] 300274 0
Ethics committee name [2] 301064 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 301064 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065?
Ethics committee country [2] 301064 0
Australia
Date submitted for ethics approval [2] 301064 0
01/10/2018
Approval date [2] 301064 0
Ethics approval number [2] 301064 0
Ethics committee name [3] 304827 0
Northern Sydney Local Health District Human Ethics Committee
Ethics committee address [3] 304827 0
NSLHD Research Office,
Level 13 Kolling Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Ethics committee country [3] 304827 0
Australia
Date submitted for ethics approval [3] 304827 0
22/01/2019
Approval date [3] 304827 0
01/04/2019
Ethics approval number [3] 304827 0
RESP/19/005

Summary
Brief summary
The aim of the study is to examine the effect of lifestyle-focused program delivered by text message on function in people with non-persistent low back pain.

304 people will be recruited to the study and randomly assigned to receive either the text message intervention or minimal intervention.

Those assigned to receive the text messages will receive semi-personalised text messages providing advice, motivation and information to improve education, physical activity, sleep, mood, use or care and medication. Participants will receive 4 text messages every week for 12 weeks. Messages will be sent on randomly selected days and at one of 4 randomly selected time slots. Participants will be eligible to receive certain messages depending on whether they have acute low back pain, sleep issues, are more than moderately active, report taking medication for their low back pain at baseline and have a sedentary job.

Health related data will be collected from all participants via online surveys following recruitment, 3 months, 6 months and 12 months after recruitment. The health data collected will be those that are recommended by the key groups in this field of research:
The Outcome Measures in Rheumatology Clinical Trials group (OMERACT)
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).

These will include measures of pain, functional status, patient reported impression of change, generic quality of life, levels of activity, health literacy and health care use and costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83118 0
Prof Manuela Ferreira
Address 83118 0
Institute of Bone and Joint Research,
The Kolling Institute and Department of Rheumatology,
University of Sydney,
Royal North Shore Hospital, Reserve Road,
St Leonards NSW 2065,
Country 83118 0
Australia
Phone 83118 0
+61 2 94631897
Fax 83118 0
Email 83118 0
manuela.ferreira@sydney.edu.au
Contact person for public queries
Name 83119 0
Miss Joanna Prior
Address 83119 0
Institute of Bone and Joint Research and Department of Rheumatology
Level 10, The Kolling Building,
University of Sydney,
Royal North Shore Hospital, Reserve Road,
St Leonards NSW 2065, Australia
Country 83119 0
Australia
Phone 83119 0
+61 2 9926 4261
Fax 83119 0
Email 83119 0
joanna.prior@sydney.edu.au
Contact person for scientific queries
Name 83120 0
Prof Manuela Ferreira
Address 83120 0
Institute of Bone and Joint Research and Department of Rheumatology
Level 10, The Kolling Building,
University of Sydney,
Royal North Shore Hospital, Reserve Road,
St Leonards NSW 2065, Australia
Country 83120 0
Australia
Phone 83120 0
+61 2 94631897
Fax 83120 0
Email 83120 0
manuela.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
No
What supporting documents are/will be available?
No other documents available
Summary results
No Results