NCT03904940

Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)

Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Nonspecific Low Back Pain

Interventions

Type	Name	Description
DEVICE	Total Contact Insole	Ethyl vinyl acetate insole shaped in the cast of the patient's foot.
DEVICE	Ethyl vinyl acetate flat insole	Flat insole made of the same material ethyl vinyl acetate

Timeline

• Start date: 2019-07-06
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2019-04-05
• Last updated: 2024-03-13

Locations

1 site across 1 country: Brazil