Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain (PCMALBP)

May 8, 2023 updated by: Rubens Alexandre da Silva Jr, Universidade Norte do Paraná

An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Athletes Chronic With Low Back Pain: A Feasibility and Clinical Trial Study

The relevance of this study is given by the feasibility to assess the effect of an intervention program based on the postural control and trunk neuromuscular activity, comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes with low back pain. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed. This is the first study to compare two intervention methods using the main biological outcomes related to trunk neuromuscular function.

Study Overview

Detailed Description

For this study, a proposal of a 8-week intervention program will be carried out with lumbar stabilization exercises and back strengthening exercises, in 32 athletes with chronic low back, recruited by convenience and voluntaries from the community local and sports centers. Before intervention, all participantes will be evaluated by: electromoyography during back endurance and strength tests, balance performance, physical capacity, and by clinical outcomes such as pain, disability and psychological factors. All baseline testing and evaluation will be performed by a blinded evaluator to the study intervention. Afterwards, the participants will be randomized in two groups by a blinded evaluator (people not enroled to study): G1: exercises for lumbar stabilization; and G2: strengthening exercises. The intervention will follow 8 weeks, with 50 minutes of duration each session of therapy including measurement of blood pressure, heart rate and the Visual Analogue Scale (VAS) before and after each session, and the perception of exercise intensity monitored by Borg Scale. Within this proposal, the exercise sessions will performed twice a week. The intervention will follow the CONSORT recommendations for randomized controlled trials. The intervention will start in: G1 (n=16, motor control group), which will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource; while G2 (n=16, strength group) will perform back endurance progressive and resisted exercises on a Roman chair. The participants will not be blind to the study due to the characteristic of the exercises that often reflect to the improvement of the symptoms. In case of eventual losses, the intention-to-treat method will be used for the analyses. After the intervention, all groups will be invited to come back to the laboratory to proceed the same evaluation from baseline (trunk activation during exercises, balance, and clinical outcomes). For the analysis two-way ANOVA with repeated measures will be performed to compare the effects of the intervention (two groups) and times (baseline vs. end 8-weeks measurement) and the effects of interaction (Groups x Times). The size effect also will be computed to determine the rate of the changes observed.

Study Type

Interventional

Enrollment (Actual)

32

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 Contact

  • Name: Rubens da Silva, PhD
  • Phone Number: 011 55 43 3371-9848
  • Email: rubens@unopar.br

Study Locations

    • Paraná
      • Londrina, Paraná, Brazil, 86041-120
        • Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • chronic low back pain at least for three months, in a unique or multiple episodes.
  • low back pain of unknown origin and mechanical nature.
  • athletes must be train or play five times in a week.
  • athletes must be participate in some official competition.

Exclusion Criteria:

  • previous surgery (locomotor appareil).
  • discal herniation diagnosis.
  • nerve root entrapment.
  • spondylolisis.
  • spondylolisthesis;
  • lumbar stenosis.
  • hip cartilage damage.
  • labral injury,
  • piriformis syndrome.
  • neurological disease.
  • no current treatment in Physiotherapy or Pilates or Manual Therapy.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G1: exercises for lumbar stabilization
Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
Other Names:
  • therapeutic exercises
Active Comparator: G2: back strengthening exercises
Back strengthening exercises. The Group 2 (G2) will perform therapy including strengthning of back muscles on a Roman chair machine for flexion and extension of trunk with load progression from training volume for endurance and strength gains.
Specific back exercises. The Group 2 (G2) will perform therapy including back strengthing exercise on a Roman chair machine to perform flexion and extension of trunk with load progressive training.
Other Names:
  • Back resistive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eletromyography measurement
Time Frame: Change from baseline muscular activation at 8 weeks
EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) and Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back activation during strength maximal protocol and endurance dynamic test.
Change from baseline muscular activation at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force platform measurement
Time Frame: Change from baseline muscular activation at 8 weeks
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
Change from baseline muscular activation at 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogic Scale
Time Frame: Change from baseline muscular activation at 8 weeks
Pain measurement using Short Version of Pain Questionnaire McGill (score 0 to 78; while higher score is determined by poor condition related to pain) and Visual Analogue Scale for pain intensity (score of 0 to 10 intensity; being 10 of poor score for VAS).
Change from baseline muscular activation at 8 weeks
Disability questionnaire
Time Frame: Change from baseline muscular activation at 8 weeks
Disability measurement using Oswestry questionnaire.
Change from baseline muscular activation at 8 weeks
Fear-avoidance questionnaire
Time Frame: Change from baseline muscular activation at 8 weeks
Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.
Change from baseline muscular activation at 8 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Rubens da Silva, PhD, Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

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.

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)

September 1, 2017

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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