LUMBAR BACK PAINNCT01576978
Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
A study testing hatha yoga in people with LUMBAR BACK PAIN and PELVIC PAIN, run by University of Campinas, Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- LUMBAR BACK PAIN, PELVIC PAIN, PREGNANCY
- What is being tested?
- hatha yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.
Who cannot join
- Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic
About this study
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 .
Read the 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.
- Conditions
- LUMBAR BACK PAIN, PELVIC PAIN, PREGNANCY
- Being tested
- hatha yoga
- Keywords
- LUMBAR BACK pain, PELVIC PAIN, PREGNANCY, HATHA YOGA
- Medical subject headings
- Low Back Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hatha yogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: hatha yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LUMBAR BACK PAINStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roseny Flávia Martins, University of Campinas, Brazil
- Investigators
- Roseny F Martins, Msc, Principal investigator, Universtity of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576978
- Sponsor's protocol ID
- w7tgp7jt
- Status last verified
- Apr 2012
- First submitted
- 24 Feb 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23506189
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hatha Yoga Exercises in Pelvic and Lumbar Back Pain in Pregnant Woman
- ClinicalTrials.gov ID
- NCT01576978
- Acronym / sponsor ID
- w7tgp7jt
- Conditions
- LUMBAR BACK PAIN, PELVIC PAIN, PREGNANCY
- Keywords
- LUMBAR BACK pain, PELVIC PAIN, PREGNANCY, HATHA YOGA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postural orientations | Active comparator | Behavioral: hatha yogaThe 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. |
| hatha yoga exercises | Active comparator | Behavioral: hatha yogaThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks.
Key exclusion criteria (1 listed)
- Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hatha yogaThe 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. | Behavioural | hatha yoga exercises, postural orientations |
Primary outcome
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Derived from this study: PubMed 23506189Martins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roseny F Martins, Msc principal investigator
Universtity of Campinas
Questions about this trial
What is this clinical trial studying?
A study testing hatha yoga in people with LUMBAR BACK PAIN and PELVIC PAIN, run by University of Campinas, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (VAS) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01576978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.