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

Sponsor
University of Brasilia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03424278
Collaborator
Military Fire Department of the Federal District (Other)
60
1
2
23
2.6

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Motor control exercises
  • Other: Resistance training exercises
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel randomized controlled trial.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
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Numerical Rating Scale (NRS) [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) [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) [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 [One day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Brasilia Brasilia Distrito Federal Brazil 72220-900

Sponsors and Collaborators

  • University of Brasilia
  • Military Fire Department of the Federal District

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wagner Rodrigues Martins, Professor, University of Brasilia
ClinicalTrials.gov Identifier:
NCT03424278
Other Study ID Numbers:
  • PPGCR1
First Posted:
Feb 6, 2018
Last Update Posted:
Jan 13, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Professor, University of Brasilia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2021