A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Index
研究概览
简要总结
This study compares three treatments for low back pain that started during pregnancy. The study hypothesizes that exercise, spinal manipulation, and a mind-body technique called neuroemotional technique (NET) equally affect pain intensity and disability associated with pregnancy-related low back pain. The study also hypothesizes that pain intensity and disability levels do not influence maternal heart rate variability (a measure of stress) and intrauterine attachment (a measure of relationship quality). Ten women will additionally provide blood and salivary oxytocin samples during pregnancy and periodically for three months after birth. These women and their babies will also be videotaped playing for 5 minutes at 2 weeks, 6 weeks, and 3 months postpartum.
详细描述
Pregnancy-related low back pain is experienced by over half of all pregnant women. In the United States it is thought of as a normal constituent of pregnancy. However, in Europe low back pain associated with pregnancy is treated. In the United States pregnancy-related low back pain is thought to resolve with birth. However about 1/3 of women who experience pregnancy-related low back pain continue to experience back pain for one year postpartum. Those women whose low back pain persists into the postpartum period are more at risk of experiencing comorbidities such as postpartum depression.
In the extrauterine life maternal pain limits a mother's ability to securely attach with her child. Furthermore, interpretation of pain intensity is influenced by the type of attachment the individual has with her parents. Little is known how maternal pain may influence intrauterine attachment. Similarly, heart rate variability is influenced by pain and by spinal manipulation in non-pregnant populations. However, normal non-pregnant patterns of heart rate variability are altered during the second and third trimesters of pregnancy, and little is known about why this happens or what this means.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20-49 years old
- •Pregnant with a singleton
- •Low back pain began during pregnancy and has lasted more than one week
- •Low back pain is reproducible with palpation
排除标准
- •Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.
- •Pain radiates below knee
- •Cannot read English
- •Plans to move away from Portland area during pregnancy
- •Not willing to be randomized to one of the three arms of the study
研究组 & 干预措施
Neuroemotional technique (NET)
Neuroemotional technique (NET) is a mind-body technique which combines elements of chiropractic medicine, Chinese medicine, and behavioral psychology. Muscle response testing, a form of functional neurology, and visceral somatic reflexes are used to ascertain whether the pain or dysfunction experienced by the participant has an emotional component. If an emotional component is present, it is identified and the original "triggering" occurrence is identified. The participant creates a snapshot of that original occurrence and while she holds that image in her mind spinal levels which innervate the associated organ are adjusted.
干预措施: Neuroemotional Technique (NET) (Procedure)
Exercise
Specific strengthening exercises demonstrated to improve pregnancy-related low back pain are taught to participants of this arm. Additionally, each participant will be evaluated and additional exercises will be prescribed relevant to her particular needs. Study participants of this arm are asked to perform the exercises at home at least once a day. Exercise is recorded in a diary. Participants follow the same study visit schedule as the two other arms.
干预措施: Exercise (Behavioral)
Spinal Manipulation
Women randomized to this arm will be evaluated for spinal subluxations and, if appropriate, treated with chiropractic manipulation. Type of manipulation is determined by presentation. Woman may be manipulated with high velocity low amplitude thrust, blocking, activator, or other appropriate means of manipulating.
干预措施: Spinal Manipulation (Procedure)
结局指标
主要结局
Roland Morris Disability Index
时间窗: Last study visit prior to birth
次要结局
- Pain Visual Analog Scale(Last Study Visit Before Birth)