Prevalence of Low Back and Pelvic Pain in Pregnant Women

NCT ID: NCT00883428

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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

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Low Back Pain Pelvic Pain

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pergnant women

Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study.

Set of questionnaires

Intervention Type OTHER

A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.

Interventions

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Set of questionnaires

A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Francisco M. Kovacs

Director of Scientific Department, Kovacs Foundation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco M Kovacs, MD, PhD

Role: STUDY_DIRECTOR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Betina Nishishinya, MD

Role: PRINCIPAL_INVESTIGATOR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Locations

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Centro de Salud de Ciudad Jardín

Málaga, Andalusia, Spain

Site Status

Centro de Salud El Limonar

Málaga, Andalusia, Spain

Site Status

Centro de Salud de Andratx

Andraxt, Balearic Islands, Spain

Site Status

Centro de Salud de Campos

Campos, Balearic Islands, Spain

Site Status

Centro de Salud Lluchmajor - Mitjorn

Lluchmajor, Balearic Islands, Spain

Site Status

Centro de Salud de La Vileta

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud del Col dén Rabassa

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud del Rafal Nou

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud Son Rullán

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud del Campo Redó

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud de Son Pisá

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, Spain

Site Status

Kovacs Foundation

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud de Santa Catalina

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud de Valldargent

Palma de Mallorca, Balearic Islands, Spain

Site Status

Centro de Salud de Santa Ponsa

Santa Ponsa, Balearic Islands, Spain

Site Status

Centro de Salud de Bembibre

Bembibre, León, Spain

Site Status

Depto. de Enfermería y Fisioterapia, Universidad de León

Ponferrada, León, Spain

Site Status

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status

Centro de Salud Benita de Avila

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 2956698 (View on PubMed)

Mens 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.

Reference Type BACKGROUND
PMID: 8725930 (View on PubMed)

Orvieto 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.

Reference Type BACKGROUND
PMID: 8122500 (View on PubMed)

Other Identifiers

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FK 28

Identifier Type: -

Identifier Source: org_study_id

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