Low Back Pain and Depression: Cohort Study

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142972
• Other study ID #: 2011/28
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: May 16, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Depression
• Depressive Disorder
• Low Back Pain
• Pelvic Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Partum Depression	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	No
Secondary	Pain Scores in the visual analogue scale	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	No
Secondary	Low back pain disability	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	No
Secondary	Pain drawing area	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	No