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Low Back PainNCT03645616

Reliability of Function Tests for People With Back Pain.

A study testing 6-minute walk test, 10 meters walk test and 30 Second Sit to Stand Test in people with Low Back Pain and Adult, run by Alessandro Haupenthal at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Low Back Pain, Adult
What is being tested?
6-minute walk test, 10 meters walk test and 30 Second Sit to Stand Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteBrazil
Study dates
1 Jun 2018to 13 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Santa Catarina Federal University

    Araranguá, Santa Catarina, 88.905-120

Other trials in Brazil

About this study

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

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.

Read the 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.

Conditions
Low Back Pain, Adult
Being tested
6-minute walk test, 10 meters walk test, 30 Second Sit to Stand Test
Keywords
Musculoskeletal disease, Stress test, Reproducibility, Gait Speed
Medical subject headings
Low Back Pain, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT03645616
Study groupRoleWhat they receive
Functional TestsExperimentalParticipants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: 10 meters walk test; Diagnostic Test: 30 Second Sit to Stand Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance traveled in meters.

    Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.

    Measured: The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest

Secondary outcomes (5)

  1. 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.

    Measured: 5 minutes

  2. Functional Incapacity

    Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.

    Measured: 10 minutes

  3. 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

    Measured: 10 minutes

  4. 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.

    Measured: 5 minutes

  5. 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.

    Measured: 30 seconds.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start1 Jun 2018
  3. Primary completion25 Oct 2018
  4. Study completion13 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645616
Sponsor's protocol ID
2.537.100
Status last verified
Dec 2018
First submitted
20 Aug 2018
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16550448

  • 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.

    PubMed 12091180

  • 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.

    PubMed 28192793

  • 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.

    PubMed 12900694

  • 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.

    PubMed 9817683

  • 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.

    PubMed 27330520

  • 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.

    PubMed 15864670

Questions about this trial

What is this clinical trial studying?

A study testing 6-minute walk test, 10 meters walk test and 30 Second Sit to Stand Test in people with Low Back Pain and Adult, run by Alessandro Haupenthal at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645616, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.

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Clinical Trial NCT03645616 | AzTrials