A pilot factorial randomised cohort trial of manual therapy or acupuncture for low back pain

Background Randomised control clinical trials of acupuncture have been hampered by the challenges of assessing it as a complex intervention. Controlling for and separating placebo effects whilst identifying its efficacy as a treatment can be difficult [1]. The comparison of acupuncture to other complex interventions has been recommended to assess the effectiveness of acupuncture against other interventions [2]. The objective of this pilot trial is to investigate the feasibility of undertaking a novel randomised cohort design study with a nested factorial RCT, investigating acupuncture alone versus manual therapy alone versus a combination of acupuncture and manual therapy versus usual care. The pilot will investigate recruitment rates to allow for planning a full-scale trial, identify any compliance issues and strategies for reducing these in a full-scale trial and assess patient’s acceptance and therapist delivery of combined therapies for the treatment of their LBP.