Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Contact Insole Group | Experimental | Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months. |
|
| Flat Insole group | Sham Comparator | Flat insole made the same material ethyl vinyl acetate, every 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Contact Insole | Device | Ethyl vinyl acetate insole shaped in the cast of the patient's foot. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Sao Paulo | São Paulo | São Paulo | 04023-090 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ethyl vinyl acetate flat insole | Device | Flat insole made of the same material ethyl vinyl acetate |
|
|
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 |