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Low Back Pain and Depression: Cohort Study

16 de maio de 2014 atualizado por: Josue Fernandez Carnero, Universidad Rey Juan Carlos

Low Back Pain Disability, Intensity and Widespread Pain and Relationship to Postpartum Depression

The aims of this study are to investigate whether pelvic pain and low back pain disability are associated with postpartum depression and to compare the prevalence between women without Low back pain and disability and women with Low Back Pain (LBP) and disability every trimester, and correlate postpartum Depression and some clinical and biopsychosocial variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in a cohort of Spanish women at 2 months postpartum.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

295 pregnant women will formed the cohort, during all pregnancy and two months after delivery. The Edinburgh Postnatal Depression Scale was used to evaluate depressive symptoms at 2 months postpartum. The LBP will be evaluated based on self-administrated questionnaire, and the patients with LBP will be classified in to lumbopelvic groups according to mechanical assessment of the lumbar spine, pelvic pain provocation tests, standard history, pain intensity on visual analogue scale, spread of pain through pain drawings and Oswestry index was used to evaluated the disability. Logistics regression analysis will performed to explain the predictors of depression.

Tipo de estudo

Observacional

Inscrição (Real)

236

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

The cohort comprised all pregnant women who were registered consecutively at this primary health care center

Descrição

Inclusion Criteria:

Inclusion criteria were being pregnant between for 12 weeks to 16 weeks,
With an expected normal pregnancy (as determined by midwife),
Being able to understand and read Spanish.

Exclusion Criteria:

Exclusion criteria were end of pregnancy before gestational weeks 37 (delivery or abortion),
Serious intellectual impairment,
Having had a systemic disease (spondylitis, infectious, vascular, metabolic or endocrine related process), rheumatic disease, fibromyalgia, lumbopelvic pain or
Verified diagnosis of spinal problems in the previous 6 months, or
A history of fracture, neoplasm or previous spinal, pelvic or femur surgery.
Another exclusion criterion was a diagnosis of depression or anxiety in the previous year.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Post-Partum Depression Prazo: change from baseline in postpartum depression at 2 months after delivery	Depressive Symptoms is assessed through the Edinburgh Postnatal Depression Scale (EPDS) (translation - Spanish). It´s a 10-item self-report scale specifically designed to screen for postpartum depression. The scale rates the intensity of depressive symptoms present within the previous 7 days. A cutoff score of ≥10 in the tests is to be used for screening purposes in primary care. When selecting this threshold the sensitivity for detection of major depression increased to almost 100% and the specificity to 82%. The participants filled it in at the first visit and two months postpartum.	change from baseline in postpartum depression at 2 months after delivery

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Pain Scores in the visual analogue scale Prazo: Participants will be followed for the duration of pregnant up to 36 weeks	The Visual Analog Scale (VAS) is used to assess pain intensity (0-100 mm, where "0" corresponded to "no pain" and "10" to the worst imaginable pain).All participants were evaluated during all their pregnancy: in the first trimester (for 12 to 16 weeks), in the second trimester (for 22 weeks) and in the third trimester (for 36 weeks)	Participants will be followed for the duration of pregnant up to 36 weeks
Low back pain disability Prazo: Participants will be followed for the duration of pregnant up to 36 weeks	Disability is measured with the Oswestry Low Back Pain and Disability Questionnaire (ODQ) to compare the prevalence between women without LBP and disability and women with LBP pain and disability every trimester. All participants were evaluated of low back disability during all their pregnancy: in the first trimester (for 12 to 16 weeks), in the second trimester (for 22 weeks) and in the third trimester (for 36 weeks).	Participants will be followed for the duration of pregnant up to 36 weeks
Pain drawing area Prazo: Participants will be followed for the duration of pregnant up to 36 weeks	Participants completed detailed pain drawings representing a human body (American Academy in Physical Medicine and Rehabilitation. 2001) to assess pain location (lumbar, pelvic and symphysis pubis). To score the spread of pain, these human body views are uniformly divided into a total of 220 squares, each measuring 0.5 x 0.5 cm. .	Participants will be followed for the duration of pregnant up to 36 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universidad Rey Juan Carlos

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2011

Conclusão Primária (Real)

1 de fevereiro de 2014

Conclusão do estudo (Real)

1 de maio de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de maio de 2014

Primeira postagem (Estimativa)

20 de maio de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)