MedTrace Logo

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

NCT03904940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Chronic Nonspecific Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-06
Primary Completion
2023-12-06
Completion
2023-12-06

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904940 on ClinicalTrials.gov