Reliability of Function Tests for People With Back Pain.

Sponsor

Alessandro Haupenthal (Other)

Overall Status

Completed

CT.gov ID

NCT03645616

Collaborator

Santa Catarina Federal University (Other)

Enrollment

Location

Arm

5.4

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Adult	Diagnostic Test: 6-minute walk test Diagnostic Test: 10 meters walk test Diagnostic Test: 30 Second Sit to Stand Test	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

All data were color coded to guarantee that the investigator who processed the data was blinded to the conditions.

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Oct 25, 2018

Actual Study Completion Date :

Nov 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Functional Tests Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.	Diagnostic Test: 6-minute walk test 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. Diagnostic Test: 10 meters walk test 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. Diagnostic Test: 30 Second Sit to Stand Test At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.

Arm

Intervention/Treatment

Experimental: Functional Tests

Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.

Diagnostic Test: 6-minute walk test

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.

Diagnostic Test: 10 meters walk test

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.

Diagnostic Test: 30 Second Sit to Stand Test

At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity [5 minutes]
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.
Functional Incapacity [10 minutes]
Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
Physical activity level [10 minutes]
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
Gait Speed [5 minutes]
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.
Functional lower extremity strength [30 seconds.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.