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Low Back Pain and Depression: Cohort Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02142972
Enrollment
236
Registered
2014-05-20
Start date
2011-10-31
Completion date
2014-05-31
Last updated
2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Low Back Pain, Pelvic Pain

Keywords

Low back pain, Oswestry questionnaire, Post-partum Depression, Pelvic pain

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Universidad Rey Juan Carlos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Post-Partum Depressionchange from baseline in postpartum depression at 2 months after deliveryDepressive 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.

Secondary

MeasureTime frameDescription
Pain Scores in the visual analogue scaleParticipants will be followed for the duration of pregnant up to 36 weeksThe 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)
Low back pain disabilityParticipants will be followed for the duration of pregnant up to 36 weeksDisability 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).
Pain drawing areaParticipants will be followed for the duration of pregnant up to 36 weeksParticipants 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. .

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026