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

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Total Contact Insole
Ethyl vinyl acetate flat insole
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring Orthotic Devices, Insoles, Quality of life, Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Total Contact Insole Group

Flat Insole group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Functional capacity measured with the 6-minute walk test
Change in 6-minute walk test. The amount of meters walked in 6 minutes.
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.
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.
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.
Amount Medication consumption
Amount of paracetamol (500mg) consumed by patient between the evaluation times
Foot pressure analysis using the AMCube FootWalk Pro program

Full Information

First Posted
April 3, 2019
Last Updated
April 4, 2019
Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT03904940
Brief Title
Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)
Acronym
(LBP)
Official Title
Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
April 6, 2019 (Anticipated)
Study Completion Date
October 6, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
Orthotic Devices, Insoles, Quality of life, Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total Contact Insole Group
Arm Type
Experimental
Arm Description
Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months.
Arm Title
Flat Insole group
Arm Type
Sham Comparator
Arm Description
Flat insole made the same material ethyl vinyl acetate, every 6 months.
Intervention Type
Device
Intervention Name(s)
Total Contact Insole
Other Intervention Name(s)
Intervention foot orthoses group
Intervention Description
Ethyl vinyl acetate insole shaped in the cast of the patient's foot.
Intervention Type
Device
Intervention Name(s)
Ethyl vinyl acetate flat insole
Other Intervention Name(s)
Placebo insole, Ethyl vinyl acetate flat insole group
Intervention Description
Flat insole made of the same material ethyl vinyl acetate
Primary Outcome Measure Information:
Title
Low back of pain intensity measured with Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline, 45, 90 and 180 days
Secondary Outcome Measure Information:
Title
Functional capacity measured with Oswestry Disability Index
Description
Change in Oswestry Disability Index score. Ranging from 0 to 100 with higher values represent a worse outcome
Time Frame
Baseline, 45, 90 and 180 days
Title
Functional capacity measured with Roland Morris Disability
Description
Change in Roland Morris Disability score. Ranging from 0 to 24 with higher values represent a worse outcome
Time Frame
Baseline, 45, 90 and 180 days
Title
Functional capacity measured with the 6-minute walk test
Description
Change in 6-minute walk test. The amount of meters walked in 6 minutes.
Time Frame
Baseline, 45, 90 and 180 days
Title
Functional capacity measured with the timed to up and go test
Description
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.
Time Frame
Baseline, 45, 90 and 180 days
Title
Quality of life measured with Short form-36 questionnaire
Description
Change in Short form-36 questionnaire score. Ranging from 0 to 100 with higher scores showing a better outcome.
Time Frame
Baseline, 45, 90 and 180 days
Title
Patient's global impression of recovery measured with a likert scale
Description
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.
Time Frame
45, 90 and 180 days after baseline
Title
Amount Medication consumption
Description
Amount of paracetamol (500mg) consumed by patient between the evaluation times
Time Frame
45, 90 and 180 days after baseline
Title
Foot pressure analysis using the AMCube FootWalk Pro program
Time Frame
baseline, 90 and 180 days after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eider Silva Lima, MsC
Phone
+551155764239
Email
eider_doutor@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eider Silva Lima, MsC

12. IPD Sharing Statement

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

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