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Completed

NCT Number: NCT03645616

Reliability of Function Tests for People With Back Pain.

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.

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Key information

Conditions

Low Back Pain Adult Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Catarina Federal University

Araranguá, Santa Catarina, 88.905-120, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

6-minute walk test

Diagnostic 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.

10 meters walk test

Diagnostic 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.

30 Second Sit to Stand Test

Diagnostic Test

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

Primary outcomes

  1. Distance traveled in meters.

    Time frame: 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 outcomes

  1. Pain intensity

    Time frame: 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.

  2. Functional Incapacity

    Time frame: 10 minutes

    Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.

  3. Physical activity level

    Time frame: 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

  4. Gait Speed

    Time frame: 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.

  5. Functional lower extremity strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alessandro Haupenthal

Other

Collaborators

  • Santa Catarina Federal University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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