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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motor Control Exercises
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low Back Pain, Clinical Instability, Motor Control Exercises, Clinical Tests

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Motor Control Exercises

Arm Description

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

Outcomes

Primary Outcome Measures

Pain (Numerical Rating Scale (0-10)
Disability (measured by 24-item Roland Morris Disability Questionnaire)
Disability will be measured by 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Function (Patient Specific Functional Scale (0-10)
Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)
11-point Global Perceived Effect Scale (-5-+5)
Depression (Beck Inventory (0-63)
Beck Inventory (0-63)
Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)
Tampa Scale for Kinesiophobia (17-68)
Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)
Fear Avoidance Beliefs Questionnaire (0-66)
Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)

Full Information

First Posted
March 19, 2015
Last Updated
June 12, 2016
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02398760
Brief Title
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention
Official Title
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low Back Pain, Clinical Instability, Motor Control Exercises, Clinical Tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Control Exercises
Arm Type
Experimental
Arm Description
(Costa LOP et al. 2009; Hodges PW et al. 2009)
Intervention Type
Other
Intervention Name(s)
Motor Control Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain (Numerical Rating Scale (0-10)
Time Frame
After Intervention (2 months), 6 months
Title
Disability (measured by 24-item Roland Morris Disability Questionnaire)
Description
Disability will be measured by 24-item Roland Morris Disability Questionnaire
Time Frame
After Intervention (2 months), 6 months
Secondary Outcome Measure Information:
Title
Function (Patient Specific Functional Scale (0-10)
Time Frame
After Intervention (2 months)
Title
Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)
Description
11-point Global Perceived Effect Scale (-5-+5)
Time Frame
After Intervention (2 months)
Title
Depression (Beck Inventory (0-63)
Description
Beck Inventory (0-63)
Time Frame
After Intervention (2 months)
Title
Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)
Description
Tampa Scale for Kinesiophobia (17-68)
Time Frame
After Intervention (2 months)
Title
Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)
Description
Fear Avoidance Beliefs Questionnaire (0-66)
Time Frame
After Intervention (2 months)
Title
Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Description
Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Time Frame
After Intervention (2 months)
Other Pre-specified Outcome Measures:
Title
Clinical Classification Scale (CCS)
Description
To assess abdominal muscles coordination (0-10)
Time Frame
After Intervention (2 months)
Title
Thoracolumbar Dissociation Clinical Test (TDCT)
Description
To assess thoracolumbar dissociation (0-10)
Time Frame
After Intervention (2 months)
Title
Changes Thickness of abdominal muscles (Transversus Abdominis, Internal and External Oblique) Measured by Ultrasound Images
Description
Measured by Ultrasound Images made with a 7.5-MHz linear transducer (Siemens, Sonoline Sienna, Issaquah, WA, USA)
Time Frame
After Intervention (2 months)
Title
Structural Lumbar Instability (Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)
Description
Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)
Time Frame
After Intervention (2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben FN Filho, PhD
Organizational Affiliation
UNIVERSIDADE ESTADUAL PAULISTA JULIO DE MESQUITA FILHO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP
City
Presidente Prudente
State/Province
SP
ZIP/Postal Code
957
Country
Brazil

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
PubMed Identifier
24853256
Citation
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.
Results Reference
background
PubMed Identifier
16181938
Citation
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.
Results Reference
background
PubMed Identifier
17033040
Citation
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.
Results Reference
background
PubMed Identifier
23492976
Citation
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.
Results Reference
background
PubMed Identifier
30822389
Citation
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.
Results Reference
derived

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

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