Low-back Pain During Pregnancy and Its Psycho-social Implications
2020年12月20日 更新者：Come Collaboration
Low-back Pain During Pregnancy and Its Psycho-social Implications. The Role of the Osteopathic Manipulative Treatment Within Its Multi-disciplinary Management. A Randomised Controlled Study
Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related lumbar pain (PLBP) are two distinct symptoms, which can occur together as lumbar-pelvic pain.The primary objective is to measure the impact of osteopathic manipulative treatment on pregnancy-related lumbar and pelvic pain.
The secondary objective is to study the interaction between pain and psycho-social factors during the gestational period.
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
75
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 44年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women aged 18-44
- Primiparae
- Single pregnancy
- Spontaneous pregnancy - fisiological pregnancy
- pregnancy >= 12 weeks
- low-back pain (between the 12th rib and the lumbo-pelvic region) and/or pelvic (in the pubic region and/or in one or both of the sacro-iliac joint and/or of the gluteal region) non specific
- consent to treatment
- absence of linguistic barriers
Exclusion Criteria:
- Women aged <18 o >44
- Pathological pregnancy, twins
- Metabolic pathologies
- Obstetrician's emergencies
- Pre-term birth
- Specific lumbar and/or pelvic pain - Genetics disorders
- Major congenital anomalies
- Absence of consent to treatment
- Presence of linguistic barriers
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：OMT + multidisciplinary path
Patients in the experimental group will follow the obstetrician's and multidisciplinary path which provides osteopathic treatments, mindfulness, yoga, clinical nutrition, coaching and usual obstetric care.
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OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment.
The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator.
A "black-box" type of treatment is undertaken.
Mindfulness group weekly meetings.
Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy.
Weekly yoga group meetings.
Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation.
In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances.
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
There will be five personalized coaching sessions during the pregnancy.
|
|
其他：Usual care
Patients in control group will continue the routine obstetrical care as established by international guidelines
|
Administration of routine care based on international guidelines
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in VAS at 6 months
大体时间：6 months
|
Change from Visual Analogue Scale (VAS) of pain at 6 months.
VAS values range from 0-10, where 10 means highest pain and 0 no pain
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6 months
|
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Change in ODI at 6 months
大体时间：6 months
|
Change from Oswestry disability index 2.1° - Italian version (ODI) of the score at 6 months.
The ODI represents a ten 6-point questionnaire.
The first section rates the intensity of pain and the remaining ones cover the disabling effect of pain on typical daily activities: personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling.
Each item ranges from 0 to 5 and the sum of the 10 scores is expressed as a percentage of the maximum scores, varying from 0 (no disability) to 100 (maximum disability)
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6 months
|
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Change in PMI at 6 months
大体时间：6 months
|
Change from Pregnancy mobility index (PMI) of the score at 6 months.
PMI is a self-report questionnaire to assess mobility in relation to back and pelvic girdle pain.
The PMI consists of three scales: daily mobility in the house, household activities and mobility outdoors.
Every item has a score option from 0-3 (respectively 'no problems performing this task', 'some effort performing this task', 'much effort performing this task', 'performing this task is impossible or only possible with the aid of others'), which was transformed to a 0-100 scale.
Each domain score is the mean of all included items.
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6 months
|
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Change in PGQ at 6 months
大体时间：6 months
|
Change from Pelvic-girdle pain questionnaire (PGQ) of the score at 6 months.
The PGQ is a condition-specific, patient-reported outcome measure designed to measure pregnancy-related back pain and pelvic girdle pain for use both during pregnancy and postpartum in research and clinical practice.
The questionnaire includes items relating to 2 scales (activity/ participation and body functions [symptoms]).
Self-report questionnaire of 20 activity items and 5 symptom items scored on a 4-point response scale.
Each question is scored from 'Not at all' (0) to 'To a large extent' (3).
Questions on the activity sub-scale range from difficulty with dressing, climbing stairs, doing housework, rolling in bed to pushing a shopping cart.
Item scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in PWB at 6 months
大体时间：6 months
|
Change from Ryff's Psychological Well-Being Scales (PWB) of the score at 6 months.
Ryff, the 42-item Psychological Wellbeing (PWB) Scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Respondents rate how strongly they agree or disagree with 42 statements using a 7-point scale (1 = strongly agree; 7 = strongly disagree).
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Niccolò Giovanni, MD、Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年12月15日
初级完成 (预期的)
2021年2月28日
研究完成 (预期的)
2021年8月30日
研究注册日期
首次提交
2020年12月15日
首先提交符合 QC 标准的
2020年12月20日
首次发布 (实际的)
2020年12月23日
研究记录更新
最后更新发布 (实际的)
2020年12月23日
上次提交的符合 QC 标准的更新
2020年12月20日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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