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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- Amount Medication consumption [ Time Frame: 45, 90 and 180 days after baseline ]Amount of paracetamol (500mg) consumed by patient between the evaluation times
- Foot pressure analysis using the AMCube FootWalk Pro program [ Time Frame: baseline, 90 and 180 days after baseline ]
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
|Universidade Federal de Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 04023-090|
|Contact: Eider Silva Lima, MsC +551155764239 email@example.com|
|Principal Investigator: Eider Silva Lima, MsC|