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Clinical Trials/NCT03645616
NCT03645616CompletedNot Applicable

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

Alessandro Haupenthal2 sites in 1 country33 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
33
Locations
2
Primary Endpoint
Distance traveled in meters.

Study Overview

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 Design

Study Type
Interventional
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 Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Functional Tests

Experimental

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

Intervention: 6-minute walk test (Diagnostic Test)

Functional Tests

Experimental

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

Intervention: 10 meters walk test (Diagnostic Test)

Functional Tests

Experimental

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

Intervention: 30 Second Sit to Stand Test (Diagnostic Test)

Outcomes

Primary Outcomes

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

  • Gait Speed(5 minutes)
  • Functional lower extremity strength(30 seconds.)
  • Pain intensity(5 minutes)
  • Functional Incapacity(10 minutes)
  • Physical activity level(10 minutes)

Investigators

Sponsor
Alessandro Haupenthal
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Alessandro Haupenthal

Principal Investigator

Universidade Federal de Santa Catarina

Study Sites (2)

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