NCT01576978

Brief Summary

The aim of this study is to identify evaluate the effectiveness of stretching exercises of Hatha Yoga method in pregnant women with back pain and posterior pelvic City Paulínia. -There will be a randomized clinical trial with 60 pregnant women with these symptoms. They will be randomly divided into 2 groups. The group A will perform the exercises of Hatha Yoga for ten weeks, once a week group B postural follow the guidelines recommended for the treatment of these pains, for ten weeks. Will be used as a technique for evaluating the Visual Analogue Scale to measure pain intensity and confirmation tests of the lumbar and posterior pelvic pain in order to differentiate them. A descriptive statistical analysis of univariate and bivariate distributions will be made through frequency and graphical representation. The association between the variables will be tested by statistical tests: \[chi-square (X ²)\], Fisher's exact test, Student's t test or Mann-Whitney, \[Student's t test to compare means\], ANOVA for the analysis of effects between the groups. \[The significance level is predetermined to 5%\]. The data will be analyzed in EPI-INFO 2000. SAS 9.0 and from the database created .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

February 24, 2012

Last Update Submit

April 11, 2012

Conditions

Keywords

LUMBAR BACK painPELVIC PAINPREGNANCYHATHA YOGA

Outcome Measures

Primary Outcomes (3)

  • Pain Visual Analog Scale (VAS)

    Ratings of pain intensity according to the pregnant woman. Checking the initial interview, the beginning and end of each session of Yoga. The scale will be presented to the patient with a drawing where you see three little faces on a graphic scale, rating pain in ascending order, with a score of zero to ten (Olsen, NOLAN, Kori, 1992)

    10 weeks

  • confirmatory low back pain test

    The therapist will ask the mother to stand with feet together, the woman held the bending bending the trunk forward until the time you start bending the legs. It is positive if patient reported back pain and reported pain with palpation of the musculature of this area and in moving the trunk in a circle.

    10 weeks

  • Confirmatory pelvic pain test

    The therapist will place the pregnant woman lying supine, ask for a leg flexion and extension of the other on the floor. The femoral leg will be bent in the vertical and the physiotherapist push towards the ground, simultaneously stabilizing the pelvis. It is positive when the patient to recognize the pain .Low back pain, Trunk Flexion the therapist will ask the mother to stand with feet together, the woman held the bending bending the trunk forward until the time you start bending the legs. It is positive if patient reported pain in the deep gluteal area and turnning night on the bed.

    10 weeks

Study Arms (2)

postural orientations

ACTIVE COMPARATOR

The group of postural orientations receive a pamphlet containing information about the sitting, standing and lying postures to be performed at home for 10 weeks.The marking of the note pain will be before and after 10 weeks.

Behavioral: hatha yoga

hatha yoga exercises

ACTIVE COMPARATOR

The allocates women will participate in the Hatha yoga class for 10 weeks. At first in class, the women will make a note of pain according to VAS. Class Moments: heating ten minutes, forty minutes postures of stretching and strengthening exercises and breathing exercises, ten minutes of relaxation and meditation. Marking note of pain after practice.

Behavioral: hatha yoga

Interventions

hatha yogaBEHAVIORAL

The women's group of Yoga will participate in ten week sessions of Yoga once a week for an hour. The sessions will be taught by instructor of Hatha Yoga. For the intervention were chosen 37 postures, three breathing exercises. The sessions were divided into three stages: quieting the mind , breathing rate and the heating of the main joints, postures and breathing exercises, meditation and relaxation. At the beginning and end of each session, we evaluated the pain intensity.Pregnant women in the control group Postural orientations will receive a booklet containing guidelines postural figures and explanatory text on some possible changes in the curvatures of the spine during pregnancy suggestions for positioning of the spine for daily activities, lying postures, sitting and standing. After ten weeks the two groups will be scheduled for the final collection of data.

hatha yoga exercisespostural orientations

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.

You may not qualify if:

  • Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Martins RF, Pinto e Silva JL. Treatment of pregnancy-related lumbar and pelvic girdle pain by the yoga method: a randomized controlled study. J Altern Complement Med. 2014 Jan;20(1):24-31. doi: 10.1089/acm.2012.0715. Epub 2013 Mar 18.

MeSH Terms

Conditions

Low Back PainPelvic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roseny F Martins, Msc

    Universtity of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator (student)

Study Record Dates

First Submitted

February 24, 2012

First Posted

April 13, 2012

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04