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Efficacy of Exercises in Individuals With Non-specific Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03424278
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Military Fire Department of the Federal District
Information provided by (Responsible Party):
Wagner Rodrigues Martins, University of Brasilia

Brief Summary:
This is a randomized controlled trial project to analyze the effectiveness of lumbar motor control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk strength in individual with chronic low back pain. The project has two parallel arms and will be supervised by physiotherapists (motor control exercises) and physical education professionals (resistance training). The participants will be Militaries of the Military Fire Department of the Federal District who presents in the recruitment regular low back pain more than 3 months. The two groups will be supervised in12 weeks of exercises in the Physical Activity Center of Military Fire Department of the Federal District. Our hypotheses is that the resistance training effects wil be superior to motor control exercises only for trunk strength (isokinetic flexion and extension).

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Motor control exercises Other: Resistance training exercises Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: An assessor who don't now in which groups the participants has been allocated.
Primary Purpose: Treatment
Official Title: Efficacy of Motor Control Exercises and Resistance Training on Pain, Function, Kinesiophobia and Trunk Strength in Individuals With Non-specific Chronic Low Back Pain
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Motor Control Other: Motor control exercises
Motor control exercises for the deep trunk muscles in patients with chronic low back pain is based on evidence of motor control dysfunction, including delayed onset of activity in the transversus abdomens and internal oblique abdominal muscles and segmental hypertrophy of the lumbar multifidus muscle.

Experimental: Resistance Training Other: Resistance training exercises
A type of strength-building exercise program that requires the body muscle to exert a force against some form of resistance, such as weight, stretch bands, water, or immovable objects. Resistance exercise is a combination of static and dynamic contractions involving shortening and lengthening of skeletal muscles.




Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) [ Time Frame: One day ]
    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

  2. Roland-Morris Disability Questionnaire (RDQ) [ Time Frame: One day ]
    Questionnaires to measure and monitor changes in functional outcome in patients with LBP. The RDQ evaluates 24 activity limitations due to LBP, while the ODI consists of 10 items assessing the level of pain interference with physical activities.

  3. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: One day ]
    Measures the excessive, irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.


Secondary Outcome Measures :
  1. Trunk Muscle strength [ Time Frame: One day ]
    This outcome will be assessed by a isokinetic dynamometer. Today dynamometry routinely assesses muscle performance in healthy and symptomatic populations.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nonspecific chronic low back pain (defined as pain and discomfort) localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain of at least 3 months' duration.

Exclusion Criteria:

  • Spinal pathology (eg, tumor, infection, fracture, inflammatory disease), pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, and presence of any contraindication to exercise.

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): NCT03424278


Locations
Brazil
University of Brasilia
Brasilia, Distrito Federal, Brazil, 72220-900
Sponsors and Collaborators
University of Brasilia
Military Fire Department of the Federal District

Publications:
Responsible Party: Wagner Rodrigues Martins, Professor, University of Brasilia
ClinicalTrials.gov Identifier: NCT03424278     History of Changes
Other Study ID Numbers: PPGCR1
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wagner Rodrigues Martins, University of Brasilia:
Low back pain
Exercise

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms