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Low Back Pain and Depression: Cohort Study

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ClinicalTrials.gov Identifier: NCT02142972
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Josue Fernandez Carnero, Universidad Rey Juan Carlos

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.

Condition or disease
Low Back Pain Pelvic Pain Depression

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.

Study Type : Observational
Actual Enrollment : 236 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Low Back Pain Disability, Intensity and Widespread Pain and Relationship to Postpartum Depression
Study Start Date : October 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Post-Partum Depression [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pain Scores in the visual analogue scale [ Time Frame: 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)

  2. Low back pain disability [ Time Frame: 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).

  3. Pain drawing area [ Time Frame: 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. .



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The cohort comprised all pregnant women who were registered consecutively at this primary health care center
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142972


Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
Principal Investigator: Josue Fernandez-Carnero, PhD Rey Juan Carlos University

Responsible Party: Josue Fernandez Carnero, PhD, Associate Professor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02142972     History of Changes
Other Study ID Numbers: 2011/28
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by Josue Fernandez Carnero, Universidad Rey Juan Carlos:
Low back pain
Oswestry questionnaire
Post-partum Depression
Pelvic pain

Additional relevant MeSH terms:
Depression
Depressive Disorder
Back Pain
Low Back Pain
Pelvic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms