Reliability of Function Tests for People With Back Pain.

Not Applicable

Completed

• Conditions: Adult; Low Back Pain
• Interventions: Diagnostic Test: 6-minute walk test; Diagnostic Test: 10 meters walk test; Diagnostic Test: 30 Second Sit to Stand Test

• Registration Number: NCT03645616
• Lead Sponsor: Alessandro Haupenthal

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2018-10-25
• Study Completion: 2018-11-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Tests	6-minute walk test	Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
Functional Tests	30 Second Sit to Stand Test	Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
Functional Tests	10 meters walk test	Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Functional Incapacity	10 minutes	Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
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.

Trial Locations

Locations (1)

Santa Catarina Federal University; 🇧🇷 Araranguá, Santa Catarina, Brazil