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Musculoskeletal and Obstetric Management Study (MOMS)

2009年5月19日 更新者:Logan College of Chiropractic

Musculoskeletal and Obstetric Management Study (MOMS)

The investigators propose such a trial to compare a Musculoskeletal and Obstetric Management (MOM) program to standard obstetric care alone for lower back pain/pelvic pain (LBP/PP) during and after pregnancy.

研究概览

详细说明

Initially patients will have a Baseline Musculoskeletal Exam (BME) at 24-28 weeks pregnancy at which point self reported tests/questionnaires will be administered as well as functional testing (see below "procedures for research") performed. At this point patients will be randomized into either Standard Obstetric Management or Musculoskeletal and Obstetric Care (MOMS) groups:

Standard Obstetric Management : All patients (both groups) will be seen for standard obstetric care typically once every month. Complicated cases may need to be seen more frequently. There is no standard obstetric care approach to LBP/PP in pregnancy, thus, patients in the standard obstetric care group will receive limited, although realistic interventions for LBP/PP. In addition, patients will attend one-on-one educational sessions on pre-natal care. The women in this group will have a minimum of 4 pre-natal care sessions. These visits will be timed to match the additional time and care given to the MOM group. The timed sessions will be compared with the MOMS group at monthly intervals to maintain treatment attention equality. Patients will have a complete medical assessment including history and physical examination administered by their obstetrical provider. As part of their intervention for LBP/PP, evaluation of lifestyle and work activities may be taken into consideration. Modification of lifestyle may be recommended including, rest and general aerobic exercise. Short-lived heat treatment (i.e. heating pad for no more than 10 minutes) is another possibility. Use of analgesia may be prescribed, including acetaminophen and NSAID preparations, or narcotics if deemed necessary by the provider. Narcotic use and centrally acting muscle relaxants are typically not encouraged, but at times maybe necessary to help control pain. For pain that is debilitating and worsening, consultation with orthopedic or neurological services may be considered.

Musculoskeletal and Obstetric Management (MOM): In addition to their standard obstetric visits, patients in this group will see the MOM team every one to two weeks depending on severity of symptoms. We have found through treating pregnancy-related pain that visits every one to two weeks is sufficient as the majority of the cases are mild to moderate presentations of non-inflammatory pain. A standard history will be taken and the patient will be assessed for musculoskeletal conditions to identify signs of serious illness, neurological deficit and/or orthopedic instability. If any of these conditions are evident, the patient will be immediately referred for specialist consultation. The patients in this MOM group will be treated with biobehavioral management, manual therapy and spinal stabilization exercise as described in detail below. The obstetric physician and chiropractic physician will have coordinated schedules at each clinic. For pain that is debilitating and worsening, consultation with orthopedic or neurological services will be considered.

Patients will be assessed at 33 weeks gestation and 3 months post-partum and research end-points collected. Please see next cell for detailed description of these functional and endurance tests as well as self reported test.

研究类型

介入性

注册 (实际的)

160

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。

学习地点

    • Missouri
      • St Louis、Missouri、美国、63110
        • Center for Advanced Medicine
      • St. Louis、Missouri、美国、63110
        • Barnes-Jewish Hospital
      • St. Louis、Missouri、美国、63131
        • Missouri Baptist Medical Center

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

15年 至 45年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female Patients 15-45 years of age
  • Pregnant - 24-28 weeks gestation
  • LBP and/or PP

Exclusion Criteria:

  • History of fracture, neoplasm, previous surgery of lumbar spine, pelvis, hip or femur
  • Acute inflammatory or infectious disease
  • Chronic pain prior to pregnancy (pain persisting for > 8 weeks prior to pregnancy)
  • Mental health disorder requiring medication/treatment
  • Back pain from visceral diseases
  • Peripheral vascular disease and/or cardiac disease requiring medical treatment
  • Severe disabling health problems
  • Substance abuse
  • Ongoing treatment for back pain by other health care providers
  • Pending or current litigation
  • Multiple birth pregnancies

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:MOMS
Receives manual therapy, stabilization exercise and patient education
Receives manual therapy, stabilization exercise and patient education
有源比较器:STOB
Receive standard obstetrical care
Receive standard obstetrical care

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Quebec Task Force Disability Scale Questionnaire (QDQ)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum

次要结果测量

结果测量
大体时间
Numerical Rating Scale (NRS)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Personal Pain History (PPH)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Straight Leg Raise (SLR)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Active Straight Leg Raise (ASLR)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Long Dorsal Ligament Test (LDLT)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Posterior Pelvic Pain in Pregnancy Test (P4)
大体时间:Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum
Extensor Endurance Test (EET)
大体时间:3 months postpartum
3 months postpartum
Flexor Endurance Test (FET)
大体时间:3 months postpartum
3 months postpartum
Side Bridge (SB)
大体时间:3 months postpartum
3 months postpartum

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。

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

2006年10月1日

初级完成 (预期的)

2009年6月1日

研究完成 (预期的)

2009年6月1日

研究注册日期

首次提交

2009年5月18日

首先提交符合 QC 标准的

2009年5月19日

首次发布 (估计)

2009年5月20日

研究记录更新

最后更新发布 (估计)

2009年5月20日

上次提交的符合 QC 标准的更新

2009年5月19日

最后验证

2009年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 06-0998
  • 417 (DRD)
  • 1 R18HP07640-01-00 (Award #)
  • R18HP07640 (Grant #)
  • RD1012060046 (Logan IRB #)

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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