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.

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, ≥18years of age, and non-specific low back pain lasting for ≥1month.

INTERVENTIONS: The 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 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 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.

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.