Low Back Pain and Depression: Cohort Study
2014年5月16日 更新者：Josue Fernandez Carnero、Universidad Rey Juan Carlos
Low Back Pain Disability, Intensity and Widespread Pain and Relationship to Postpartum Depression
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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
236
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～45年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
The cohort comprised all pregnant women who were registered consecutively at this primary health care center
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-Partum Depression
時間枠：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.
|
change from baseline in postpartum depression at 2 months after delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Scores in the visual analogue scale
時間枠：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)
|
Participants will be followed for the duration of pregnant up to 36 weeks
|
|
Low back pain disability
時間枠：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).
|
Participants will be followed for the duration of pregnant up to 36 weeks
|
|
Pain drawing area
時間枠：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. .
|
Participants will be followed for the duration of pregnant up to 36 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年10月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年5月1日
試験登録日
最初に提出
2014年5月7日
QC基準を満たした最初の提出物
2014年5月16日
最初の投稿 (見積もり)
2014年5月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年5月20日
QC基準を満たした最後の更新が送信されました
2014年5月16日
最終確認日
2014年5月1日
詳しくは
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