No increase in 6-week treatment effect of Mechanical Diagnosis and Therapy with the use of the LUMBOback in people with non-acute non-specific low back pain and a directional preference of extension: a pilot randomized controlled trial.

Objectives: To pilot the methods for a randomized controlled trial (RCT) to investigate whether the treatment effect of Mechanical Diagnosis and Therapy (MDT) is enhanced with the LUMOback. Design: Assessor blinded RCT with 3 and 6-week follow-ups. Setting: An outpatient clinic. Participants: Primary eligibility criteria were: a directional preference of lumbar extension, ≥18 years of age, and non-specific low back pain lasting for ≥1 month. ACCEPTED MANUSCRIPT 2 Interventions: The MDT group undertook extension exercises (10 reps/3h) and postural correction using a lumbar roll at home. The MDT+LUMOback group also wore the LUMOback daily, providing a vibration alert in a slouched posture. Main outcome measures: The Global Rating of Change Scale (GRCS) (0-6), recruitment rate per month, treatment sessions, compliance rate of wearing the LUMOback, participants’ adherence with treatment, dropout rate and the stage of the MDT program at six weeks. Results: Twenty-two participants were included for 20 months (a recruitment rate of 1.1 patients/month). Dropout rate was 9%. The mean (SD) of the GRCS of the MDT and MDT+LUMOback groups were 4.7 (0.8) and 4.7 (0.5) at the 3-week follow-up and were both 4.9 (0.5) at the 6-week follow-up. The patients undertook a mean of 6.7 sessions for six weeks and exercises with mean of 3.7 set/day in each group. The mean compliance rate of wearing the LUMOback was 88%. Nobody was discharged from the intervention with full recovery within six weeks. Conclusions: Data indicated a promising method for the full RCT, but a rationale for the full RCT was not justified. Clinical Trial Registration number: UMIN000018380 Contribution of paper  It was the ultimate aim to investigate if the treatment effect of Mechanical Diagnosis and Therapy (MDT) could be enhanced with the use of real-time feedback with the LUMOback in patients with a directional preference of lumbar extension.  Regarding the methodology to achieve that aim, recruitment of participants in multiple centers was considered necessary, because of the low recruitment rate in the current study. ACCEPTED MANUSCRIPT 3  However, further investigation in a multi-center trial using the current methods is not justified due to the lack of difference in the treatment effect of MDT within six weeks, with or without the use of the LUMOback for assisting postural correction. Keywords: back pain; exercise therapy; lumbosacral region; manipulative therapies; posture; proprioceptive feedback