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

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motor control exercises
Resistance training exercises
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Exercise

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Motor Control

Resistance Training

Arm Description

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS)
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'.
Roland-Morris Disability Questionnaire (RDQ)
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.
Tampa Scale for Kinesiophobia (TSK)
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

Trunk Muscle strength
This outcome will be assessed by a isokinetic dynamometer. Today dynamometry routinely assesses muscle performance in healthy and symptomatic populations.

Full Information

First Posted
January 31, 2018
Last Updated
August 12, 2023
Sponsor
University of Brasilia
Collaborators
Military Fire Department of the Federal District
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1. Study Identification

Unique Protocol Identification Number
NCT03424278
Brief Title
Efficacy of Exercises in Individuals With Non-specific Chronic Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The participants recruitment was to difficult
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
Military Fire Department of the Federal District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
An assessor who don't now in which groups the participants has been allocated.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Control
Arm Type
Active Comparator
Arm Title
Resistance Training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Motor control exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance training exercises
Intervention Description
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 Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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'.
Time Frame
One day
Title
Roland-Morris Disability Questionnaire (RDQ)
Description
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.
Time Frame
One day
Title
Tampa Scale for Kinesiophobia (TSK)
Description
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.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Trunk Muscle strength
Description
This outcome will be assessed by a isokinetic dynamometer. Today dynamometry routinely assesses muscle performance in healthy and symptomatic populations.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
72220-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27128390
Citation
Saragiotto BT, Maher CG, Yamato TP, Costa LOP, Costa LCM, Ostelo RWJG, Macedo LG. Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review. Spine (Phila Pa 1976). 2016 Aug 15;41(16):1284-1295. doi: 10.1097/BRS.0000000000001645.
Results Reference
background
PubMed Identifier
26742533
Citation
Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
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
25931693
Citation
Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015 Mar;27(3):619-22. doi: 10.1589/jpts.27.619. Epub 2015 Mar 31.
Results Reference
background
PubMed Identifier
25452128
Citation
Steele J, Bruce-Low S, Smith D. A review of the clinical value of isolated lumbar extension resistance training for chronic low back pain. PM R. 2015 Feb;7(2):169-87. doi: 10.1016/j.pmrj.2014.10.009. Epub 2014 Oct 29.
Results Reference
background
PubMed Identifier
21791457
Citation
Kristensen J, Franklyn-Miller A. Resistance training in musculoskeletal rehabilitation: a systematic review. Br J Sports Med. 2012 Aug;46(10):719-26. doi: 10.1136/bjsm.2010.079376. Epub 2011 Jul 26.
Results Reference
background

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

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