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Reliability of Function Tests for People With Back Pain.

NCT ID: NCT03645616

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-11-13

Brief Summary

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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

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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.

Conditions

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Low Back Pain Adult

Keywords

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Musculoskeletal disease Stress test Reproducibility Gait Speed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

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Functional Tests

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

Group Type EXPERIMENTAL

6-minute walk test

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Catarina Federal University

OTHER

Sponsor Role collaborator

Alessandro Haupenthal

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Haupenthal

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aline L Ballico, Student

Role: PRINCIPAL_INVESTIGATOR

Santa Catarina Federal University

Locations

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Santa Catarina Federal University

Araranguá, Santa Catarina, Brazil

Site Status

Countries

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Brazil

References

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Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

Reference Type BACKGROUND
PMID: 16550448 (View on PubMed)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type BACKGROUND
PMID: 12091180 (View on PubMed)

Britto RR, Sousa LAP. Teste de caminhada de seis minutos- Uma normatização brasileira. Fisioterapia em Movimento 19(4):49-54, 2006.

Reference Type BACKGROUND

Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.

Reference Type BACKGROUND
PMID: 28192793 (View on PubMed)

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.

Reference Type BACKGROUND
PMID: 9817683 (View on PubMed)

Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.

Reference Type BACKGROUND
PMID: 27330520 (View on PubMed)

Lamoth CJ, Meijer OG, Daffertshofer A, Wuisman PI, Beek PJ. Effects of chronic low back pain on trunk coordination and back muscle activity during walking: changes in motor control. Eur Spine J. 2006 Jan;15(1):23-40. doi: 10.1007/s00586-004-0825-y. Epub 2005 Apr 29.

Reference Type BACKGROUND
PMID: 15864670 (View on PubMed)

Other Identifiers

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2.537.100

Identifier Type: -

Identifier Source: org_study_id