Clinical trial NCT01576978: Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
Official title: Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LUMBAR BACK PAIN
PELVIC PAIN
PREGNANCY
Keywords: LUMBAR BACK pain
PELVIC PAIN
PREGNANCY
HATHA YOGA
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: 10 weeks
measure: confirmatory low back pain test
timeFrame: 10 weeks
measure: Confirmatory pelvic pain test
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universtity of Campinas
name: Roseny F Martins, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.