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Clinical Trials/NCT02969785
NCT02969785
Completed
N/A

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

Universidade Norte do Paraná1 site in 1 country32 target enrollmentSeptember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Athletic Injury
Sponsor
Universidade Norte do Paraná
Enrollment
32
Locations
1
Primary Endpoint
Eletromyography measurement
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Universidade Norte do Paraná
Responsible Party
Principal Investigator
Principal Investigator

Rubens Alexandre da Silva Jr

Professor

Universidade Norte do Paraná

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Force platform measurement(Change from baseline muscular activation at 8 weeks)

Study Sites (1)

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