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NCT00883428 Clinical Trial

Prevalence of Low Back and Pelvic Pain in Pregnant Women

Low Back Pain Clinical Trial

Official title:
Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00883428
Other study ID # FK 28
Secondary ID
Status Completed
Phase N/A
First received April 16, 2009
Last updated March 11, 2014
Start date June 2009
Est. completion date June 2011

Study information
Verified date March 2014
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Etico de Investigación Clínica de la Fundación KovacsSpain: Comité Ético de Investigación Clínica de las Islas Baleares
Study type Observational

Clinical 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. Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1158
Est. completion date June 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 48 Years
Eligibility 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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Spain Centro de Salud de Andratx Andraxt Balearic Islands
Spain Centro de Salud de Bembibre Bembibre León
Spain Centro de Salud de Campos Campos Balearic Islands
Spain Centro de Salud Lluchmajor - Mitjorn Lluchmajor Balearic Islands
Spain Centro de Salud Benita de Avila Madrid
Spain Fundación Jiménez Díaz Madrid
Spain Centro de Salud de Ciudad Jardín Málaga Andalucía
Spain Centro de Salud El Limonar Málaga Andalucía
Spain Centro de Salud de La Vileta Palma de Mallorca Balearic Islands
Spain Centro de Salud de Santa Catalina Palma de Mallorca Balearic Islands
Spain Centro de Salud de Son Pisá Palma de Mallorca Balearic Islands
Spain Centro de Salud de Valldargent Palma de Mallorca Balearic Islands
Spain Centro de Salud del Campo Redó Palma de Mallorca Balearic Islands
Spain Centro de Salud del Col dén Rabassa Palma de Mallorca Balearic Islands
Spain Centro de Salud del Rafal Nou Palma de Mallorca Balearic Islands
Spain Centro de Salud Son Rullán Palma de Mallorca Balearic Islands
Spain Hospital Son Dureta Palma de Mallorca Balearic Islands
Spain Kovacs Foundation Palma de Mallorca Balearic Islands
Spain Depto. de Enfermería y Fisioterapia, Universidad de León Ponferrada León
Spain Centro de Salud de Santa Ponsa Santa Ponsa Balearic Islands

Sponsors (1)
Lead Sponsor Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy. 24 months No
Secondary The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women. 30 months No
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