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Low Back Pain and Depression: Cohort Study

16. mai 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

236

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Post-Partum Depression Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain Scores in the visual analogue scale Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad Rey Juan Carlos

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2011

Primær fullføring (Faktiske)

1. februar 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

7. mai 2014

Først innsendt som oppfylte QC-kriteriene

16. mai 2014

Først lagt ut (Anslag)

20. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)