Reliability of Function Tests for People With Back Pain.

Study Overview
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Brief Summary
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Back pain is often accompanied by changes in function. The performance of individuals with their backs on their wills may become more functional. It is believed that the test will present good to excellent reliability in individuals with chronic back pain. From this, it can be used in the clinic to verify the functional capacity of these individuals.

Detailed Description
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This study will be performed to verify the reliability of the functional tests for individuals with back pain. A study in which individuals with back pain will be assessed on the first day and after the interval of seven days. They should perform the 6-minute walk test and answer some questionnaires such as the Roland Morris - disability questionnaire, the IPAQ - physical activity level questionnaire and Numeric Rating Scale, after the tests will be performed Timed 10-Meter Walk Test and 30 Second Sit to Stand Test. To avoid a random error, a minimum sample size of 30 participants is required. For statistical analysis, Shapiro-Wilk test will be used for data normalization and the reliability between measurements will be calculated through do Intraclass Correlation Coefficients, standard error of measurement and Minimal Detectable Change. There were no studies in the literature and recorded in the Clinical Trials that evaluated the reliability of these tests for individuals with chronic low back pain.

Official Title
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Reliability of Functional Tests for Individuals With Chronic Low Back Pain.

Conditions
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Low Back Pain, Adult

Intervention / Treatment
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* Diagnostic Test: 6-minute walk test
* Diagnostic Test: 10 meters walk test
* Diagnostic Test: 30 Second Sit to Stand Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes aged 20 to 65 years and low back pain for more than 3 months. Exclusion Criteria: Acute pain of back pain that disables the performance of the tests. Pregnancy. Neoplasms. Known heart, lung or metabolic diseases. Hypotension (BP < 90 x 60 mmHg) or stage II hypertension (BP > 140 x 90 mmHg), medicated or not. Fall or faint in the previous two months. Have not undergone any spinal surgery. Have not had neuromuscular impairment in the last three months and who need help to follow the instructions.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Tests<br>Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test. | Diagnostic Test: 6-minute walk test<br>* First day: Participants undertook 6-minute walk test. There was a 30-minute interval between the first and second test, when the patient was asked to rest. During the resting period, they respond a pain intensity, functional capacity and physical activity level questionnaire. Second day: the participants repeated the test and questionnaires.<br>Diagnostic Test: 10 meters walk test<br>* First day: After the second 6-minute walk test the participants perform the 10-meter walk test, the test must be performed three times with a 30-second interval, at the end the average test velocity. Second day: the participants repeated the test.<br>Diagnostic Test: 30 Second Sit to Stand Test<br>* At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance traveled in meters. | Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes. | The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Measured through the Numerical Rating Scale, being considered an improvement of pain, the reduction of 2,5 points in the NRS. Evaluated at the beginning and after the tests. | 5 minutes | 
| Functional Incapacity | Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points. | 10 minutes | 
| Physical activity level | The scores obtained through the International Physical Activity Questionnaire (IPAQ) are obtained through the minutes of activities performed per week, classifying the individual as very active, active, irregularly active and sedentary | 10 minutes | 
| Gait Speed | Measured through the 10 meters walk test that measures walking speed in meters per second for a short period. Individual walks without assistance 10 meters (32.8 feet) and the time is measured for the intermediate 6 meters (19.7 feet) to allow for acceleration and deceleration. | 5 minutes | 
| Functional lower extremity strength | Measured through the 30 Second Sit to Stand Test, which evaluates the functional limb strength with the number of sit and stand repetitions for 30 seconds. | 30 seconds. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal disease, Stress test, Reproducibility, Gait Speed