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Reliability of Function Tests for People With Back Pain.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03645616
Enrollment
33
Registered
2018-08-24
Start date
2018-06-01
Completion date
2018-11-13
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Adult

Keywords

Musculoskeletal disease, Stress test, Reproducibility, Gait Speed

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.

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.

Interventions

DIAGNOSTIC_TEST6-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_TEST10 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_TEST30 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.

Sponsors

Santa Catarina Federal University
CollaboratorOTHER
Alessandro Haupenthal
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Masking description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Pain intensity5 minutesMeasured 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 Incapacity10 minutesMeasured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
Physical activity level10 minutesThe 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 Speed5 minutesMeasured 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 strength30 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026