|Study title: Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial
Authors: Cambron J, Dexheimer J, Duarte M, Freels S.
Authorâs Affiliations: Department of Research, National University of Health Sciences, Lombard, IL, USA; School of Public Health, Division of Epidemiology and Biostatistics, University of Illinois, Chicago, IL, USA.
Publication information: Archives of Physical Medicine and Rehabilitation 2017; 98(9): 1752-62.
Research done in the podiatric field has shown the use of foot orthoses is effective for the relief of low-back pain and that back pain may be related to a disruption in the kinetic chain. The authors suggest that foot dysfunction, therefore, should be considered as a potential contributing factor when treating patients with LBP and dysfunction.
The objective of this study was to investigate the effectiveness of Foot Levelers shoe orthotics with and without chiropractic treatment for chronic low back pain, compared with no treatment.
Six hundred eighty-two people were screened by telephone, with 416 of them found to be eligible. Of those, 290 appeared for the baseline visit and 225 were randomized to a group.
Compliance with the interventions was as follows:
- 86.7 per cent of the shoe orthotic plus chiropractic group participants were compliant with chiropractic care and 96.8 per cent were compliant with orthotic use. 92.5 per cent of the shoe orthotic subjects were compliant with orthotic use.
- Average LBP was significantly decreased after six weeks in all three groups, as follows:
- less than one-point improvement in the waitlist group,
- 1.9-point improvement in the shoe orthotic only group, and
- 2.3-point improvement in the shoe orthotic plus chiropractic group.
ODI disability scores improved significantly in both intervention groups:
- less than 1-point improvement (not significant) in the waitlist group,
- 2.3-point improvement in the shoe orthotic only group, and
- 4.3-point improvement in the shoe orthotic plus chiropractic group.
When chiropractic care was added to the orthotic treatment, outcomes were better than with orthotic care alone, being statistically significant for ODI (P = 0.0278) but not for average pain (P = 0.3431).
Changes between groups that were observed early in the study were not significantly different at later time points for either outcome.
Minimal clinically important difference scores in this study were set at a minimum 30 per cent change from baseline. While the three groups were significantly different at six weeks, the greatest changes were in the shoe orthotic plus chiropractic group where 70 per cent of the subjects experienced a decrease in pain and 56 per cent a decrease in disability from baseline. For comparison, subjects in the shoe orthotic only group experienced 58 per cent and 38 per cent decreases, respectively, and only 22 per cent and 20 per cent in the waitlist group.
Prescription shoe orthotics resulted in significantly improved back pain and function compared with no treatment at six weeks and the addition of chiropractic care resulted in higher improvements in function. However, the differences between groups at 12 weeks and beyond were not significant.
This study provides practitioners with preliminary evidence that prescription shoe orthotics may be effective in the treatment of patients with CLBP.
These results should be confirmed by additional studies that attempt to control for some limitations that were present; for instance, blinding of the researchers and/or including a sham orthotic group.
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