Clinical trial NCT02142972: Low Back Pain and Depression: Cohort Study
Official title: Low Back Pain Disability, Intensity and Widespread Pain and Relationship to Postpartum Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Pelvic Pain
Depression
Keywords: Low back pain
Oswestry questionnaire
Post-partum Depression
Pelvic pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort comprised all pregnant women who were registered consecutively at this primary health care center

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.

Eligibility 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.

Primary outcomes:
measure: Post-Partum Depression
timeFrame: change from baseline in postpartum depression at 2 months after delivery
Secondary outcomes:
measure: Pain Scores in the visual analogue scale
timeFrame: Participants will be followed for the duration of pregnant up to 36 weeks
measure: Low back pain disability
timeFrame: Participants will be followed for the duration of pregnant up to 36 weeks
measure: Pain drawing area
timeFrame: Participants will be followed for the duration of pregnant up to 36 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernandez-Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References: