NCT03645616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

August 20, 2018

Last Update Submit

December 12, 2018

Conditions

Low Back PainAdult

Keywords

Musculoskeletal diseaseStress testReproducibilityGait Speed

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain intensity

    5 minutes

  • Functional Incapacity

    10 minutes

  • Physical activity level

    10 minutes

  • Gait Speed

    5 minutes

  • Functional lower extremity strength

    30 seconds.

Study Arms (1)

Functional Tests

EXPERIMENTAL

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

Diagnostic Test: 6-minute walk testDiagnostic Test: 10 meters walk testDiagnostic Test: 30 Second Sit to Stand Test

Interventions

6-minute walk testDIAGNOSTIC_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.

Functional Tests
10 meters walk testDIAGNOSTIC_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.

Functional Tests
30 Second Sit to Stand TestDIAGNOSTIC_TEST

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

Functional Tests

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes aged 20 to 65 years and low back pain for more than 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Catarina Federal University

Araranguá, Santa Catarina, 88.905-120, Brazil

Location

Related 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(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

    PMID: 16550448BACKGROUND

  • 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.

    PMID: 12091180BACKGROUND

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

    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.

    PMID: 28192793BACKGROUND

  • 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.

    PMID: 12900694BACKGROUND

  • 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.

    PMID: 9817683BACKGROUND

  • 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.

    PMID: 27330520BACKGROUND

  • 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.

    PMID: 15864670BACKGROUND

MeSH Terms

Conditions

Low Back PainMusculoskeletal Diseases

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aline L Ballico, Student

    Santa Catarina Federal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All data were color coded to guarantee that the investigator who processed the data was blinded to the conditions.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 24, 2018

Study Start

June 1, 2018

Primary Completion

October 25, 2018

Study Completion

November 13, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)