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

Chronic Low Back Pain Clinical Trial

Official title:

Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398760
• Other study ID #: UEPJMF-5402
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: June 12, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP	Presidente Prudente	SP

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Byström 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. — View 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. — View 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. — View 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

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. Epub 2006 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Classification Scale (CCS)	To assess abdominal muscles coordination (0-10)	After Intervention (2 months)	No
Other	Thoracolumbar Dissociation Clinical Test (TDCT)	To assess thoracolumbar dissociation (0-10)	After Intervention (2 months)	No
Other	Changes Thickness of abdominal muscles (Transversus Abdominis, Internal and External Oblique) Measured by Ultrasound Images	Measured by Ultrasound Images made with a 7.5-MHz linear transducer (Siemens, Sonoline Sienna, Issaquah, WA, USA)	After Intervention (2 months)	No
Other	Structural Lumbar Instability (Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)	Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET)	After Intervention (2 months)	No
Primary	Pain (Numerical Rating Scale (0-10)		After Intervention (2 months), 6 months	No
Primary	Disability (measured by 24-item Roland Morris Disability Questionnaire)	Disability will be measured by 24-item Roland Morris Disability Questionnaire	After Intervention (2 months), 6 months	No
Secondary	Function (Patient Specific Functional Scale (0-10)		After Intervention (2 months)	No
Secondary	Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)	11-point Global Perceived Effect Scale (-5-+5)	After Intervention (2 months)	No
Secondary	Depression (Beck Inventory (0-63)	Beck Inventory (0-63)	After Intervention (2 months)	No
Secondary	Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)	Tampa Scale for Kinesiophobia (17-68)	After Intervention (2 months)	No
Secondary	Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)	Fear Avoidance Beliefs Questionnaire (0-66)	After Intervention (2 months)	No
Secondary	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)	After Intervention (2 months)	No