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

NCT02398760 | Completed DMC

• 1 other identifier: UEPJMF-5402
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Low Back Pain; Clinical Instability; Motor Control Exercises; Clinical Tests

Outcome Measures

Primary Outcomes (2)

• Pain (Numerical Rating Scale (0-10)

  After Intervention (2 months), 6 months

• 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

Secondary Outcomes (6)

• Function (Patient Specific Functional Scale (0-10)

  After Intervention (2 months)

• Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)

  After Intervention (2 months)

• Depression (Beck Inventory (0-63)

  After Intervention (2 months)

• Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)

  After Intervention (2 months)

• Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)

  After Intervention (2 months)

Other Outcomes (4)

• Clinical Classification Scale (CCS)

  After Intervention (2 months)

• Thoracolumbar Dissociation Clinical Test (TDCT)

  After Intervention (2 months)

• Changes Thickness of abdominal muscles (Transversus Abdominis, Internal and External Oblique) Measured by Ultrasound Images

  After Intervention (2 months)

Study Arms (1)

Motor Control Exercises

EXPERIMENTAL

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

Other: Motor Control Exercises

Interventions

Motor Control Exercises 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.

Motor Control Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• cardiovascular and neurological pathologies
• serious pathology in the spine and pelvic.
• previous spinal surgery of at least 1 year before the trial period.
• classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP

Presidente Prudente, São Paulo, 957, Brazil

Location

Related Publications (6)

• 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

  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.

  PMID: 24853256 BACKGROUND

• 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.

  PMID: 16181938 BACKGROUND

• 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.

  PMID: 17033040 BACKGROUND

• 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.

  PMID: 23492976 BACKGROUND

• 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.

  PMID: 30822389 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruben FN Filho, PhD

  UNIVERSIDADE ESTADUAL PAULISTA JULIO DE MESQUITA FILHO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Student

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 26, 2015
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

BR (1)