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

August 12, 2023 updated by: Wagner Rodrigues Martins, University of Brasilia

Efficacy of Motor Control Exercises and Resistance Training on Pain, Function, Kinesiophobia and Trunk Strength in Individuals With Non-specific Chronic Low Back Pain

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 72220-900
        • University of Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
One day
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.
One day
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.
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

Military Fire Department of the Federal District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Actual)

February 10, 2017

Study Completion (Estimated)

November 10, 2017

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPGCR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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