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Influence of an Exercise for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain.

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ClinicalTrials.gov Identifier: NCT02056197
Recruitment Status : Unknown
Verified January 2014 by Paulo Roberto Garcia Lucareli, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Paulo Roberto Garcia Lucareli, University of Nove de Julho

Brief Summary:

Motor control exercises have demonstrated a good option for recovery from chronic low back pain. The purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface.

We hypothesized the unstable group will present pain reduction and functional improvement.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Placebo Other: Stable surface exercises Other: Unstable surface exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of an Exercise Program for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain: Single-blind, Randomized Controlled Clinical Trial.
Study Start Date : May 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Shortwave 30 minutes.
Other: Placebo
Shortwave

Active Comparator: Stable
Stable surface exercises
Other: Stable surface exercises
Stable surface exercises

Experimental: Unstable
Unstable surface exercises
Other: Unstable surface exercises



Primary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-specific low back pain
  • Sedentary
  • Previous low back pain last 6 months

Exclusion Criteria:

  • Traumatic, inflammatory, infectious or tumours etiology
  • Positive neurological findings (leg pain)
  • Pregnancy
  • Previous spine or lower limb surgery
  • Contraindicated for short-waves aplication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056197


Contacts
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Contact: André S Bley, MS +5511995216393

Locations
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Brazil
Universidade Nove de Julho Recruiting
São Paulo, Brazil, 02117-020
Contact: André S Bley, MS    +5511995216393    andrebley@uninove.br   
Principal Investigator: Paulo RG Lucareli, PhD         
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Study Chair: Paulo RG Lucareli, PhD University of Nove de Julho
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Responsible Party: Paulo Roberto Garcia Lucareli, Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02056197    
Other Study ID Numbers: PL002
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms