Reliability of Function Tests for People With Back Pain.

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645616
• Other study ID #: 2.537.100
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: December 2018
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 13, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• Back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Santa Catarina Federal University	Araranguá	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Alessandro Haupenthal	Santa Catarina Federal University

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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:S192-300. — View Citation

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

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

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. Review. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View Citation

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. — View Citation

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. Erratum in: J Chiropr Med. 2017 Dec;16(4):346. — View Citation

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. Epub 2005 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance traveled in meters.	Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.	The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest
Secondary	Pain intensity	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.	5 minutes
Secondary	Functional Incapacity	Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.	10 minutes
Secondary	Physical activity level	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	10 minutes
Secondary	Gait Speed	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 minutes
Secondary	Functional lower extremity strength	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.	30 seconds.