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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Nonspecific Low Back Pain
• Intervention / Treatment: Device: Total Contact Insole; Device: Ethyl vinyl acetate flat insole

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023-090
      • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total Contact Insole Group; Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months.	Device: Total Contact Insole; Ethyl vinyl acetate insole shaped in the cast of the patient's foot.; Other Names: Intervention foot orthoses group
Sham Comparator: Flat Insole group; Flat insole made the same material ethyl vinyl acetate, every 6 months.	Device: Ethyl vinyl acetate flat insole; Flat insole made of the same material ethyl vinyl acetate; Other Names: Placebo insole; Ethyl vinyl acetate flat insole group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back of pain intensity measured with Numeric Pain Rating Scale	It will be measured by the Brazilian version of the Numeric Pain Rating Scale 10 cm. The Numeric Pain Rating Scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last week. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.	Baseline, 45, 90 and 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity measured with Oswestry Disability Index	Change in Oswestry Disability Index score. Ranging from 0 to 100 with higher values represent a worse outcome	Baseline, 45, 90 and 180 days
Functional capacity measured with Roland Morris Disability	Change in Roland Morris Disability score. Ranging from 0 to 24 with higher values represent a worse outcome	Baseline, 45, 90 and 180 days
Functional capacity measured with the 6-minute walk test	Change in 6-minute walk test. The amount of meters walked in 6 minutes.	Baseline, 45, 90 and 180 days
Functional capacity measured with the timed to up and go test	Change in timed to up and go test. Amount of time that the patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	Baseline, 45, 90 and 180 days
Quality of life measured with Short form-36 questionnaire	Change in Short form-36 questionnaire score. Ranging from 0 to 100 with higher scores showing a better outcome.	Baseline, 45, 90 and 180 days
Patient's global impression of recovery measured with a likert scale	The Likert scale. The patients answered the question 'After starting the use the insoles, how do you think your low back is?' with one of the following statements: much worse, a little worse, unchanged, a little better, much better.	45, 90 and 180 days after baseline
Amount Medication consumption	Amount of paracetamol (500mg) consumed by patient between the evaluation times	45, 90 and 180 days after baseline
Foot pressure analysis using the AMCube FootWalk Pro program		baseline, 90 and 180 days after baseline

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2019
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Function; Insoles; Orthotic Devices
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Federal University Sao Paulo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No