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Clinical Trials/NCT02933086
NCT02933086
Completed
N/A

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

Universidade Norte do Paraná1 site in 1 country20 target enrollmentNovember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy Complications
Sponsor
Universidade Norte do Paraná
Enrollment
20
Locations
1
Primary Endpoint
Eletromyography measurement
Status
Completed
Last Updated
7 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 functionality and trunk neuromuscular activity and postural control in pregnant women 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 segment function.

Detailed Description

For this study, a proposal of a 6-week intervention program will be carried out with lumbar stabilization exercises and clinical orientations, on 20 low back pregnant patients recruited by convenience and voluntaries from the community. Before intervention, all participantes will be evaluated by: electromoyography during three exercises, balance, and 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: conventional therapy. The intervention will follow six 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 be twice a week, lasting 40 minutes each, and followed by 10 minutes of theoretical orientation. The intervention will follow the CONSORT recommendations for randomized controlled trials. The intervention will start in: G1 (n=10), which will perform therapy with specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource; while G2 (n=10, control group) will perform conventional therapy including stretching of lower limbs and trunk. 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 three 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 6-weeks measurement)the effects of interaction (Groups x Times).

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Universidade Norte do Paraná
Responsible Party
Principal Investigator
Principal Investigator

Rubens Alexandre da Silva Jr

Titular professor

Universidade Norte do Paraná

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Eletromyography measurement

Time Frame: Change from baseline muscular activation at 6 weeks

Level of muscular activaity of trunk from eletromyography surface processing.

Secondary Outcomes

  • Force platform measurement(Change from baseline balance performance at 6 weeks)

Study Sites (1)

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