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

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ClinicalTrials.gov Identifier: NCT03904940
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Anamaria Jones, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Chronic Nonspecific Low Back Pain Device: Total Contact Insole Device: Ethyl vinyl acetate flat insole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : April 6, 2019
Estimated Study Completion Date : October 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904940


Locations
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Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04023-090
Contact: Eider Silva Lima, MsC    +551155764239    eider_doutor@hotmail.com   
Principal Investigator: Eider Silva Lima, MsC         
Sponsors and Collaborators
Federal University of São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Responsible Party: Anamaria Jones, Head of Rheumatology Rehabilitation Section - Rheumatology Division, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03904940     History of Changes
Other Study ID Numbers: Federal University Sao Paulo
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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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
Keywords provided by Anamaria Jones, Federal University of São Paulo:
Orthotic Devices
Insoles
Quality of life
Function
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms