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

NCT ID: NCT03904940

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-06
• Study Completion Date: 2023-12-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total Contact Insole Group

Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months.

Group Type: EXPERIMENTAL

Total Contact Insole

Intervention Type: DEVICE

Ethyl vinyl acetate insole shaped in the cast of the patient's foot.

Flat Insole group

Flat insole made the same material ethyl vinyl acetate, every 6 months.

Group Type: SHAM_COMPARATOR

Ethyl vinyl acetate flat insole

Intervention Type: DEVICE

Flat insole made of the same material ethyl vinyl acetate

Interventions

Total Contact Insole

Ethyl vinyl acetate insole shaped in the cast of the patient's foot.

Intervention Type: DEVICE

Ethyl vinyl acetate flat insole

Flat insole made of the same material ethyl vinyl acetate

Intervention Type: DEVICE

Other Intervention Names

Intervention foot orthoses group; Placebo insole; Ethyl vinyl acetate flat insole group

Eligibility Criteria

Inclusion Criteria

• Low back pain for more than 3 months, with numeric pain scale between 3 - 8 cm;
• Over 18 years;
• No distinction of sex;
• Understand Portuguese well enough to be able to fill in the questionnaires;
• Agree to participate of the study and sign the informed consent form.

Exclusion Criteria

• Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
• Litigation;
• Fibromyalgia;
• Other symptomatic musculoskeletal diseases in lower limbs;
• Symptomatic diseases of the central and peripheral nervous system;
• Diabetes Mellitus;
• Rigid deformities on foot;
• Use of insoles in the last three months;
• Medical or physiotherapeutic treatment for low back pain or any problem in lower limbs in the last three months;
• People who had changed physical activity or undergone physical therapy in the previous 3 months;
• Pregnancy;
• Difference of lower limbs greater than 2 cm
• Less than 6 months after lumbar spine, lower limb or abdomen surgery
• Previous spinal surgery;
• Previous spinal infiltration for pain relief in the last 3 months;
• Serious scoliosis;
• Allergy to the material of the insole.
• Planned travel in the next 12 weeks;
• Geographic inaccessibility.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Anamaria Jones

Head of Rheumatology Rehabilitation Section - Rheumatology Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Federal University Sao Paulo

Identifier Type: -

Identifier Source: org_study_id