Low Back Pain and Depression: Cohort Study

NCT ID: NCT02142972

Last Updated: 2014-05-20

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

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain Pelvic Pain Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* With an expected normal pregnancy (as determined by midwife),
* Being able to understand and read Spanish.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josue Fernandez-Carnero, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Other Identifiers

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2011/28

Identifier Type: -

Identifier Source: org_study_id

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