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Completed

NCT Number: NCT03904940

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

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.

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Key information

Conditions

Chronic Nonspecific Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04023-090, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Contact Insole

Device

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

Other names: Intervention foot orthoses group

Ethyl vinyl acetate flat insole

Device

Flat insole made of the same material ethyl vinyl acetate

Other names: Placebo insole, Ethyl vinyl acetate flat insole group

Primary outcomes

  1. Low back of pain intensity measured with Numeric Pain Rating Scale

    Time frame: Baseline, 45, 90 and 180 days

    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 outcomes

  1. Functional capacity measured with Oswestry Disability Index

    Time frame: Baseline, 45, 90 and 180 days

    Change in Oswestry Disability Index score. Ranging from 0 to 100 with higher values represent a worse outcome

  2. Functional capacity measured with Roland Morris Disability

    Time frame: Baseline, 45, 90 and 180 days

    Change in Roland Morris Disability score. Ranging from 0 to 24 with higher values represent a worse outcome

  3. Functional capacity measured with the 6-minute walk test

    Time frame: Baseline, 45, 90 and 180 days

    Change in 6-minute walk test. The amount of meters walked in 6 minutes.

  4. Functional capacity measured with the timed to up and go test

    Time frame: Baseline, 45, 90 and 180 days

    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.

  5. Quality of life measured with Short form-36 questionnaire

    Time frame: Baseline, 45, 90 and 180 days

    Change in Short form-36 questionnaire score. Ranging from 0 to 100 with higher scores showing a better outcome.

  6. Patient's global impression of recovery measured with a likert scale

    Time frame: 45, 90 and 180 days after baseline

    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.

  7. Amount Medication consumption

    Time frame: 45, 90 and 180 days after baseline

    Amount of paracetamol (500mg) consumed by patient between the evaluation times

  8. Foot pressure analysis using the AMCube FootWalk Pro program

    Time frame: baseline, 90 and 180 days after baseline

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: (LBP)

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2019
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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