Low Back PainNCT00883428
Prevalence of Low Back and Pelvic Pain in Pregnant Women
An observational study of Low Back Pain and Pelvic Pain, run by Kovacs Foundation at 20 sites in Spain.
Trial summary
The purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women. The results should allow for the identification of factors associated with a greater risk of having it during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pelvic Pain
- What is being tested?
- Set of questionnaires
- How many people
- 1,158 participants
- Where
- 20 sitesSpain
- Study dates
- Jun 2009to Jun 2011
- Phase
- Observational
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).
Who may be able to join
- A pregnancy of 28 weeks or more
- Able to understand, read and write Spanish
- Seen at participating health centers or hospitals in the study
- Signs informed consent form
Who cannot join
- Refusal to participate in the study
- Being under 18 years of age or legally mentally incapacitated
- Having a diagnosis of illnesses that can cause back pain
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Centro de Salud de Andratx
Andraxt, Balearic Islands, 07150
Centro de Salud de Bembibre
Bembibre, León, 24300
Centro de Salud de Campos
Campos, Balearic Islands, 07630
Centro de Salud Lluchmajor - Mitjorn
Lluchmajor, Balearic Islands, 07620
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Centro de Salud Benita de Avila
Madrid, Madrid, 28043
Centro de Salud de Ciudad Jardín
Málaga, Andalusia, 29014
Centro de Salud El Limonar
Málaga, Andalusia, 29016
Centro de Salud de La Vileta
Palma de Mallorca, Balearic Islands, 07000
Centro de Salud del Col dén Rabassa
Palma de Mallorca, Balearic Islands, 07007
Centro de Salud del Rafal Nou
Palma de Mallorca, Balearic Islands, 07008
Centro de Salud Son Rullán
Palma de Mallorca, Balearic Islands, 07008
Centro de Salud del Campo Redó
Palma de Mallorca, Balearic Islands, 07010
Centro de Salud de Son Pisá
Palma de Mallorca, Balearic Islands, 07011
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07012
Kovacs Foundation
Palma de Mallorca, Balearic Islands, 07012
Centro de Salud de Santa Catalina
Palma de Mallorca, Balearic Islands, 07013
Centro de Salud de Valldargent
Palma de Mallorca, Balearic Islands, 07013
Depto. de Enfermería y Fisioterapia, Universidad de León
Ponferrada, León, 24400
Centro de Salud de Santa Ponsa
Santa Ponsa, Balearic Islands, 07180
About this study
Official title: Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it
The purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women. The results should allow for the identification of factors associated with a greater risk of having it during pregnancy. Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.
Read the detailed description
Validated methods were used to gather data on the prevalence of LBP, LP and PGP, anthropometric and socio-demographic characteristics, history of LBP, obstetrical history, physical activity before and during pregnancy, mattress and sleep characteristics, disability, anxiety, and depression. Separate multiple logistic regression models were developed to identify the variables associated with LBP, LP and PGP.
- Conditions
- Low Back Pain, Pelvic Pain
- Being tested
- Set of questionnaires
- Keywords
- low back pain, pelvic pain, pregnancy
- 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.
Set of questionnairesOther
A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Pergnant women | Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study. Receives: Other: Set of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.
Measured: 24 months
Secondary outcomes (1)
The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainBetina Nishishinya, MD, Principal investigator, Kovacs Foundation, Palma de Mallorca, 07012, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883428
- Sponsor's protocol ID
- FK 28
- Status last verified
- Mar 2014
- First submitted
- 16 Apr 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fast A, Shapiro D, Ducommun EJ, Friedmann LW, Bouklas T, Floman Y. Low-back pain in pregnancy. Spine (Phila Pa 1976). 1987 May;12(4):368-71. doi: 10.1097/00007632-198705000-00011.
PubMed 2956698Mens JM, Vleeming A, Stoeckart R, Stam HJ, Snijders CJ. Understanding peripartum pelvic pain. Implications of a patient survey. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1363-9; discussion 1369-70. doi: 10.1097/00007632-199606010-00017.
PubMed 8725930Orvieto R, Achiron A, Ben-Rafael Z, Gelernter I, Achiron R. Low-back pain of pregnancy. Acta Obstet Gynecol Scand. 1994 Mar;73(3):209-14. doi: 10.3109/00016349409023441.
PubMed 8122500
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it
- ClinicalTrials.gov ID
- NCT00883428
- Acronym / sponsor ID
- FK 28
- Conditions
- Low Back Pain, Pelvic Pain
- Keywords
- low back pain, pelvic pain, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,158 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Apr 2009 (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 purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women. The results should allow for the identification of factors associated with a greater risk of having it during pregnancy. Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.
Detailed description
Validated methods were used to gather data on the prevalence of LBP, LP and PGP, anthropometric and socio-demographic characteristics, history of LBP, obstetrical history, physical activity before and during pregnancy, mattress and sleep characteristics, disability, anxiety, and depression. Separate multiple logistic regression models were developed to identify the variables associated with LBP, LP and PGP.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pergnant women | – | Other: Set of questionnairesPregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).
Key inclusion criteria (4 listed)
- A pregnancy of 28 weeks or more
- Able to understand, read and write Spanish
- Seen at participating health centers or hospitals in the study
- Signs informed consent form
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Being under 18 years of age or legally mentally incapacitated
- Having a diagnosis of illnesses that can cause back pain
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 |
|---|---|---|
| Set of questionnairesA set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors. | Other | Pergnant women |
Primary outcome
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy.
Time frame: 24 months
1 secondary outcome
The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women.
Time frame: 30 months
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 Mar 2014.
- Background: PubMed 2956698Fast A, Shapiro D, Ducommun EJ, Friedmann LW, Bouklas T, Floman Y. Low-back pain in pregnancy. Spine (Phila Pa 1976). 1987 May;12(4):368-71. doi: 10.1097/00007632-198705000-00011.
- Background: PubMed 8725930Mens JM, Vleeming A, Stoeckart R, Stam HJ, Snijders CJ. Understanding peripartum pelvic pain. Implications of a patient survey. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1363-9; discussion 1369-70. doi: 10.1097/00007632-199606010-00017.
- Background: PubMed 8122500Orvieto R, Achiron A, Ben-Rafael Z, Gelernter I, Achiron R. Low-back pain of pregnancy. Acta Obstet Gynecol Scand. 1994 Mar;73(3):209-14. doi: 10.3109/00016349409023441.
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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.
Francisco M Kovacs, MD, PhD study director
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Betina Nishishinya, MD principal investigator
Kovacs Foundation, Palma de Mallorca, 07012, Spain
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Pelvic Pain, run by Kovacs Foundation at 20 sites in Spain.
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 4 inclusion and 3 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy. (time frame: 24 months). 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 NCT00883428, which also lists 3 linked publications.
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 Mar 2014.