Reliability of Function Tests for People With Back Pain.
Primary Purpose
Low Back Pain, Adult
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
6-minute walk test
10 meters walk test
30 Second Sit to Stand Test
Sponsored by
About this trial
This is an interventional screening trial for Low Back Pain focused on measuring Musculoskeletal disease, Stress test, Reproducibility, Gait Speed
Eligibility Criteria
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.
Sites / Locations
- Santa Catarina Federal University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional Tests
Arm Description
Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
Outcomes
Primary Outcome Measures
Distance traveled in meters.
Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.
Secondary Outcome Measures
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.
Functional Incapacity
Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
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
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.
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.
Full Information
NCT ID
NCT03645616
First Posted
August 20, 2018
Last Updated
December 12, 2018
Sponsor
Alessandro Haupenthal
Collaborators
Santa Catarina Federal University
1. Study Identification
Unique Protocol Identification Number
NCT03645616
Brief Title
Reliability of Function Tests for People With Back Pain.
Official Title
Reliability of Functional Tests for Individuals With Chronic Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alessandro Haupenthal
Collaborators
Santa Catarina Federal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Adult
Keywords
Musculoskeletal disease, Stress test, Reproducibility, Gait Speed
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All data were color coded to guarantee that the investigator who processed the data was blinded to the conditions.
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Tests
Arm Type
Experimental
Arm Description
Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
Intervention Type
Diagnostic Test
Intervention Name(s)
6-minute walk test
Intervention Description
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
Intervention Name(s)
10 meters walk test
Intervention Description
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
Intervention Name(s)
30 Second Sit to Stand Test
Intervention Description
At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.
Primary Outcome Measure Information:
Title
Distance traveled in meters.
Description
Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.
Time Frame
The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
5 minutes
Title
Functional Incapacity
Description
Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
Time Frame
10 minutes
Title
Physical activity level
Description
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
Time Frame
10 minutes
Title
Gait Speed
Description
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.
Time Frame
5 minutes
Title
Functional lower extremity strength
Description
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.
Time Frame
30 seconds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline L Ballico, Student
Organizational Affiliation
Santa Catarina Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Catarina Federal University
City
Araranguá
State/Province
Santa Catarina
ZIP/Postal Code
88.905-120
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16550448
Citation
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.
Results Reference
background
PubMed Identifier
12091180
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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
background
Citation
Britto RR, Sousa LAP. Teste de caminhada de seis minutos- Uma normatização brasileira. Fisioterapia em Movimento 19(4):49-54, 2006.
Results Reference
background
PubMed Identifier
28192793
Citation
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.
Results Reference
background
PubMed Identifier
12900694
Citation
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.
Results Reference
background
PubMed Identifier
9817683
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. doi: 10.1164/ajrccm.158.5.9710086. Erratum In: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393.
Results Reference
background
PubMed Identifier
27330520
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.
Results Reference
background
PubMed Identifier
15864670
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. doi: 10.1007/s00586-004-0825-y. Epub 2005 Apr 29.
Results Reference
background
Learn more about this trial
Reliability of Function Tests for People With Back Pain.
We'll reach out to this number within 24 hrs