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

Abstract

ObjectivesTo 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. DesignAssessor blinded RCT with 3 and 6-week follow-ups. SettingAn outpatient clinic. ParticipantsPrimary eligibility criteria were: a directional preference of lumbar extension, ≥18years of age, and non-specific low back pain lasting for ≥1month. InterventionsThe MDT group undertook extension exercises (10reps/3hour) 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 measuresThe 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. ResultsTwenty-two participants were included for 20 months (a recruitment rate of 1.1 patient/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 3.7set/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. ConclusionsData indicated a promising method for the full RCT, but a rationale for the full RCT was not justified.Clinical Trial Registration number: UMIN000018380.