The effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain: a pilot randomised controlled trial

This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan. The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.