Effectiveness of rocker sole shoes in the management of chronic low back pain : A randomised clinical trial
Study Design. Multi-centre, assessor-blind, randomised, clinical trial.Objective. To compare the effectiveness of rocker sole footwear to traditional flat sole footwear as part of the management for people with low back pain (LBP).Summary of Background Data. Over the past decade, persistent advertising has claimed that footwear constructed with a rocker sole will reduce LBP. However, there is no robust evidence to support these claims.Methods. 115 people with chronic LBP were randomised to wear a rocker sole shoe or a flat sole shoe for a minimum of two hours each day while standing and walking. Primary outcome was the Roland Morris Disability Questionnaire (RMDQ). In addition, participants attended an exercise and education programme once a week for four weeks and wore their assigned shoes during these sessions. Participants were assessed without knowledge of group allocation pre-randomisation, and at six weeks, six months and one year (main outcome point). Analysis was by intention-to-treat.Results. At 12 months, data from 44/58 (77·2%) of the rocker sole group and 49/57 (84·5%) of the flat sole group was available for analysis. In the rocker sole group, mean reduction in RMDQ was -3.1 (95% C.I -4.5 to -1.6) and in the flat sole group -4.4 (95% C.I -5.8 to -3.1) (a greater negative value represents a greater reduction in disability). At six months, more people wearing flat shoes compared to rocker shoes demonstrated a minimal clinically important improvement in disability (53.2% and 31.1% respectively, p = 0.03). Between-group differences were not significant for RMDQ or any secondary outcomes (e.g. pain) at any time. People reporting pain when standing and walking at baseline (n = 59) reported a greater reduction in RMDQ at 12 months in the flat sole group (-4.4 (95% C.I -6.0 to -2.8), n = 29)) than the rocker sole group (-2.0 (95% C.I -3.6 to -0.4), n = 30)) (p <0.05).Conclusions. Rocker sole shoes appear to be no more beneficial than flat sole shoes in affecting disability and pain outcomes in people with CLBP. Flat shoes are more beneficial for LBP aggravated by standing or walking.