Skip to main content
OpenTrials
Completed

NCT Number: NCT02933086

An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Pregnant With Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Londrina, Paraná, 86041-120, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria were:

  • Have between 19-29 weeks of pregnancy;
  • Have performed prenatal clinical monitoring;
  • Have chronic low back pain (> 3 months) without irradiation for knees.
  • Not being under medication or physical therapy treatment for low back pain in the last three months;
  • To be able to perform physical activity consistent to the pregnancy;
  • To present normal conditions of responsiveness, cognition and speaking;
  • To be voluntary.

The exclusion criteria were:

  • Signs or symptoms of other pathology including coexisting pathology, a recent history (within 3 months) of surgery in the locomotor system;
  • Respiratory, neurological or cardiovascular diseases.
  • Several musculoskeletal disorders.
  • Limitations for physical exercise.
  • Allergic reaction to adhesive tape,

Treatment and study plan

Specific exercises for lumbar stabilization

Other

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.

Conventional Therapy

Other

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.

Primary outcomes

  1. Eletromyography measurement

    Time frame: Change from baseline muscular activation at 6 weeks

    Level of muscular activaity of trunk from eletromyography surface processing.

Secondary outcomes

  1. Force platform measurement

    Time frame: Change from baseline balance performance at 6 weeks

    Force platform measurement during balance performance using centre of pressure measures to assess balance performance.

Other outcomes

  1. Visual Analogic Scale

    Time frame: Change from baseline pain intensity at 6 weeks.

    Pain measurement using Short Version of Pain Questionnaire Mc Gill and Visual Analogue Scale (VAS).

  2. Disability questionnaire

    Time frame: Change from baseline disability status at 6 weeks.

    Disability measurement using Roland Morris questionnaire.

  3. Fear-avoidance questionnaire

    Time frame: Change from baseline Fear-avoidance status at 6 weeks.

    Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.

Sponsors and collaborators

Lead sponsor

Universidade Norte do Paraná

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Oct 14, 2016
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.