Background: Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted.
Objective: To assesses the feasibility and acceptability of procedures for TOPS: Trial Of Prevention Strategies for low back pain.
Design: Randomised controlled pilot trial.
Methods: This is a trial of an 8 week, physiotherapist-led group exercise and education program for preventing recurrence of low back pain (LBP) in those recently recovered from LBP. We assessed the feasibility of recruitment and data-collection procedures, acceptability of the trial interventions and loss-to-follow up.
Results: The feasibility of recruitment, acceptability of the intervention and feasibility of physical activity data-collection procedures were all below anticipated levels. We enrolled 12 participants over 44 weeks, the adherence rate for the intervention group was 63% and valid physical activity data were obtained for 67% of the measurements. Follow-up methods for collection of LBP recurrence were successful with this information able to be collected for 100% of participants.
Conclusion: In response to the pilot, modifications were made to the main trial protocol. We will increase recruitment by relaxing inclusion criteria and expanding recruitment sites to include workplaces, community centres and via social media. We will facilitate compliance by expanding treatment sites to provide more options for participants to access the program and we will limit missing data by checking the validity of baseline physical activity measures prior to enrolment.
Trial registration: The study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: ACTRN12614000706673).
Keywords: Exercise; Low back pain; Physiotherapy; Pilot trial; Prevention.
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