An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain
Condition: Pregnancy Complications; Low Back Pain
MeSH terms: Pregnancy Complications; Back Pain; Low Back Pain
Study type: Interventional

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).
    

Intervention name(s): Specific exercises for lumbar stabilization; Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): 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.; The Group 2 (G2) will perform conventional therapy including stretching of lower limbs and trunk, with passive stretching of hamstrings; gluteus maximus; piriform; paraspinals; lumbar square; latissimus dorsi; scalene; trapezius.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pregnant; Low Back Pain; Postural Control