Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention

NCT ID: NCT02398760

Last Updated: 2016-06-14

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-02-29

Brief Summary

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Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. However, even though the studies in this area have increased, questions of this nature remaining without an adequate answer, or with limited evidence. Therefore, the investigators propose to examine the ability of clinical tests, developed to assess alterations related to clinical lumbar instability, to identify subgroups of patients with non specific chronic low back pain that may have better outcomes after a motor control exercises intervention.

Detailed Description

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Changes relative to clinical instability are well established in individuals with non specific chronic low back pain. However, in this population, these changes vary widely, characterizing them as an heterogenous group. Motor Control Exercises (MCE) aims to improve the impaired coordination of deep and superficial muscles of the trunk, to reestablish the stability of the lumbar spine reducing the common alterations in this population, and are associated with reduction of pain and disability of patients with non specific chronic low back pain. To specific assessment of the changes found in this population, clinical tests are often used: in the assessment to identify motor control alterations; during intervention as parameter for treatment progress (e.g. to increase exercises difficulty); and after intervention, to ensure that there was normalization of the motor control. There are several clinical tests to assess changes relative to clinical instability, such as: Clinical Classification Scale (CCS) to assess abdominal muscles and the coordination between superficial and deep trunk muscles; Clinical Test of Thoracolumbar Dissociation (CTTD) to assess anterior/posterior tilt while maintain a constant position of thoracolumbar junction; and the Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET) used to detect structural lumbar instability.

Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motor Control Exercises

(Costa LOP et al. 2009; Hodges PW et al. 2009)

Group Type EXPERIMENTAL

Motor Control Exercises

Intervention Type OTHER

Subjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks.

Interventions

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Motor Control Exercises

Subjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* between 18 and 60 years.
* non specific chronic low back (pain for more than 3 months) with pain intensity of at least 3 points measured by pain numerical rating scale (0-10) and disability of at least 6 points in the 24-item Roland Morris Disability Questionnaire (0-24).
* classified as low or medium risk though StarT Back Screening Tool

Exclusion Criteria

* cardiovascular and neurological pathologies
* serious pathology in the spine and pelvic.
* previous spinal surgery of at least 1 year before the trial period.
* check-list with the red flags was performed to exclusion
* classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Crystian Bitencourt Soares de Oliveira

Msc Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruben FN Filho, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIVERSIDADE ESTADUAL PAULISTA JULIO DE MESQUITA FILHO

Locations

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Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP

Presidente Prudente, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Hodges PW, Ferreira PH, Ferreira ML. Lumbar spine: Treatment of instability and disorders of movement control. Magee DJ, Zachazewski JE, Quillen WS, editors. Pathology and Intervention in Musculoskeletal Rehabilitation. St. Louis: Saunders Elsevier. 2009;401

Reference Type BACKGROUND

Elgueta-Cancino E, Schabrun S, Danneels L, Hodges P. A clinical test of lumbopelvic control: development and reliability of a clinical test of dissociation of lumbopelvic and thoracolumbar motion. Man Ther. 2014 Oct;19(5):418-24. doi: 10.1016/j.math.2014.03.009. Epub 2014 Mar 30.

Reference Type BACKGROUND
PMID: 24853256 (View on PubMed)

Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.

Reference Type BACKGROUND
PMID: 16181938 (View on PubMed)

Kasai Y, Morishita K, Kawakita E, Kondo T, Uchida A. A new evaluation method for lumbar spinal instability: passive lumbar extension test. Phys Ther. 2006 Dec;86(12):1661-7. doi: 10.2522/ptj.20050281. Epub 2006 Oct 10.

Reference Type BACKGROUND
PMID: 17033040 (View on PubMed)

Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.

Reference Type BACKGROUND
PMID: 23492976 (View on PubMed)

Oliveira CB, Pinto RZ, Schabrun SM, Franco MR, Morelhao PK, Silva FG, Damato TM, Negrao Filho RF. Association Between Clinical Tests Related to Motor Control Dysfunction and Changes in Pain and Disability After Lumbar Stabilization Exercises in Individuals With Chronic Low Back Pain. Arch Phys Med Rehabil. 2019 Jul;100(7):1226-1233. doi: 10.1016/j.apmr.2019.01.019. Epub 2019 Feb 26.

Reference Type DERIVED
PMID: 30822389 (View on PubMed)

Other Identifiers

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UEPJMF-5402

Identifier Type: -

Identifier Source: org_study_id

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