- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576978
Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES
General Purpose Identify the percentage of pregnant women with spinal postural pains in antenatal services in the city of Paulinia and evaluate the effectiveness of the Classical Yoga exercises for the lumbar and posterior pelvic pains in the group of women who will do the exercises, as well as developments pain intensity in patients with and without exercise.
Specific Objectives
- Identify the percentage of pregnant women with postural pains in the spine.
- Measure the intensity of pain and at the beginning and end of intervention in both groups.
- Measure the intensity of pain and at the beginning and end of each exercise session.
- To compare the evolution of pain - lower back and posterior pelvic pain - in the group with and without exercise.
- To compare the evolution of pain - lower back and posterior pelvic pain - in the group with Yoga exercises.
ASSUMPTIONS
- Half of pregnant women report symptoms of postural pains in the spine.
- A significantly higher percentage of pregnant women who will do the Yoga exercises during pregnancy report improvement in pain intensity - low back and / or posterior pelvic pain - compared with the control group.
- A significantly higher percentage of pregnant women present pain intensity increased at the beginning compared to the end of the session.
- A significantly higher percentage of pregnant women report a decrease in intensity of back pain and posterior pelvic pain when compared to the control group.
- A significantly higher percentage of pregnant women report improvement in low back pain over the posterior pelvic pain in the group with Yoga exercises.
SUBJECTS AND METHODS:
Design Identification of the percentage of pregnant women with postural pains in the spine in health units and clinical trial, prospective, randomized and controlled.
Sample Size To calculate the sample size was calculated as the average change in pain intensity referred to the global active stretching group at the end of the first and eighth week of treatment. The mean and standard deviation of the intensity of pain at the end of the first week was 4.88 SD 3.056 and at the end of the eighth week 0.85 SD 1.875 (Martins & PINTO E SILVA, 2005 b) The assumption is that the effect of treatment with yoga is similar to that found with the global active stretching.
Considering a significance level of 5%, a test power of 80%, based on the mean difference reported and adopting the paired t-test, the smallest sample size required is n = 7 women in each group.
However, for purposes of research and publication is suggested to adopt an "n" greater than 30 women per group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.
Exclusion Criteria:
- Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: postural orientations
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.
|
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.
|
Active Comparator: hatha yoga exercises
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Visual Analog Scale (VAS)
Time Frame: 10 weeks
|
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
Time Frame: 10 weeks
|
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
Time Frame: 10 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roseny F Martins, Msc, Universtity of Campinas
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- w7tgp7jt
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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