Chronic Nonspecific Low Back Pain Clinical Trial
Official title:
Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
Non-specific low back pain is a common condition. Insoles are one of the many treatment form for chronic nonspecific LBP. The investigators hypothesized the contact total insole group will present pain reduction and functional improvement. The aim of this study is to assess the effectiveness of contact total insole for people with nonspecific chronic low back pain and the impact of this insole on function, quality of life, load distribution in the plantar region, gait variables and satisfaction with insole use.
A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Eighty-four patients with nonspecific chronic low back pain will be randomly into a study group and control group. One week following the baseline evaluation, the study group will receive a contact total insole made of ethyl vinyl acetate and the control group will receive a flat insole made of the same material, color and density. The groups will be evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters will be employed: low back pain numerical pain scale; functional capacity (Oswestry and roland morris questionnaire, six minute walk test and timed to up and go test); quality of life (Short Form-36) and foot pressure analysis using the AMCube FootWalk Pro program. ;
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