Aim:
This study aimed to assess the feasibility of a randomised controlled trial comparing a mobile app (combining pain education and clinical hypnosis) to a digital guideline-informed factsheet for people with chronic low back pain attending general practice.
Methods:
Adults (≥18 years of age) with non-specific chronic low back pain attending general practices in Australia were recruited using a pre-consultation digital tool. Eligible individuals were randomised to access an 8-week mobile app intervention (which included daily clinical hypnosis and pain education sessions) or a single webpage with a guideline-informed factsheet for managing low back pain. Feasibility outcomes included randomisation rates, recruitment rates, attrition rates and questionnaire completion rates both at baseline and 8-week follow-up.
Results:
Out of 1,431 individuals who expressed interest, 304 provided contact details, and 153 were eligible. Sixty participants were randomised to receive the mobile app (n=30) or the digital guideline-informed factsheet (n=30). Five participants on average were randomised each week during the 13-week study period. Recruitment and attrition were enhanced through email and phone contact with participants. Of the 60 participants randomised, 56 (93%) completed all post-treatment follow-up questionnaires at 8 weeks. Two participants formally withdrew from the study, and two participants were lost to follow-up. Participants were a mean (SD) 51.4 (13.4) years old, reporting a mean (SD) baseline pain intensity of 6.1 (2.0) on a 0 to 10 Numeric Rating Scale and a mean (SD) baseline disability of 9.8 (4.4) on the 0 to 24 Roland-Morris Disability Questionnaire.
Conclusion:
These findings indicate that conducting a trial in general Australian practices for chronic low back pain is feasible. Recruitment and attrition rates suggest it is achievable to enrol 720 participants over two years.