Recruitment

Recruitment Status
Completed

Summary

Conditions
  • Lumbar Back Pain
  • Pelvic Pain
  • Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

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 w...

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.

Tracking Information

NCT #
NCT01576978
Collaborators
Not Provided
Investigators
Principal Investigator: Roseny F Martins, Msc Universtity of Campinas