None listed
Conditions
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.
Interventions
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 bee
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed