Catharine Siân MacRae1, Jeremy S Lewis, Adam P Shortland, Matthew C Morrissey, Duncan Critchley. 1. *Therapy Department, Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom †Department of Allied Health Professions, School of Health and Social Work, University of Hertfordshire, Hatfield, United Kingdom; ‡Musculoskeletal Services, Central London Community Healthcare NHS Trust, London, United Kingdom; §Therapy Department, St George's Hospital NHS Trust, London, United Kingdom; ¶Imaging Sciences and Biomedical Engineering, King's College London, London, United Kingdom; ‖One Small Step Gait Laboratory, Guy's and St Thomas' NHS Foundation Trust, King's Health Partners, London, United Kingdom; **Department of Physical Therapy, University of St Augustine for Health Sciences, Austin, TX; ††Faculty of Health Sciences, University of Ljubljana, Slovenia; and ‡‡Division of Health and Social Care Research, School of Medicine, King's College London, London, United Kingdom.
Abstract
STUDY DESIGN: Multicenter, assessor-blind, randomized, 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: During 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:One hundred fifteen people with chronic LBP were randomized to wear rocker sole shoes or flat sole shoes for a minimum of 2 hours each day while standing and walking. Primary outcome was the Roland Morris Disability Questionnaire (RMDQ). In addition, participants attended an exercise and education program once a week for 4 weeks and wore their assigned shoes during these sessions. Participants were assessed without their knowledge of group allocation prerandomization, and at 6 weeks, 6 months, and 1 year (main outcome point). Analysis was by intention-to-treat method. RESULTS: At 12 months, data from 44 of 58 (77.2%) of the rocker sole group and 49 of 57 (84.5%) of the flat sole group were available for analysis. In the rocker sole group, mean reduction in RMDQ was -3.1 (95% CI [confidence interval], -4.5 to -1.6), and in the flat sole group, it was -4.4 (95% CI, -5.8 to -3.1) (a greater negative value represents a greater reduction in disability). At 6 months, more people wearing flat shoes compared with those wearing 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% CI, -6.0 to -2.8], n = 29) than the rocker sole group (-2.0 [95% CI, -3.6 to -0.4], n = 30) (P < 0.05). CONCLUSION:Rocker sole shoes seem to be no more beneficial than flat sole shoes in affecting disability and pain outcomes in people with chronic LBP. Flat shoes are more beneficial for LBP aggravated by standing or walking. LEVEL OF EVIDENCE: N/A.
RCT Entities:
STUDY DESIGN: Multicenter, assessor-blind, randomized, 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: During 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: One hundred fifteen people with chronic LBP were randomized to wear rocker sole shoes or flat sole shoes for a minimum of 2 hours each day while standing and walking. Primary outcome was the Roland Morris Disability Questionnaire (RMDQ). In addition, participants attended an exercise and education program once a week for 4 weeks and wore their assigned shoes during these sessions. Participants were assessed without their knowledge of group allocation prerandomization, and at 6 weeks, 6 months, and 1 year (main outcome point). Analysis was by intention-to-treat method. RESULTS: At 12 months, data from 44 of 58 (77.2%) of the rocker sole group and 49 of 57 (84.5%) of the flat sole group were available for analysis. In the rocker sole group, mean reduction in RMDQ was -3.1 (95% CI [confidence interval], -4.5 to -1.6), and in the flat sole group, it was -4.4 (95% CI, -5.8 to -3.1) (a greater negative value represents a greater reduction in disability). At 6 months, more people wearing flat shoes compared with those wearing 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% CI, -6.0 to -2.8], n = 29) than the rocker sole group (-2.0 [95% CI, -3.6 to -0.4], n = 30) (P < 0.05). CONCLUSION: Rocker sole shoes seem to be no more beneficial than flat sole shoes in affecting disability and pain outcomes in people with chronic LBP. Flat shoes are more beneficial for LBP aggravated by standing or walking. LEVEL OF EVIDENCE: N/A.
Authors: Hylton B Menz; Maria Auhl; Jade M Tan; Pazit Levinger; Edward Roddy; Shannon E Munteanu Journal: Arthritis Care Res (Hoboken) Date: 2016-05 Impact factor: 4.794