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临床试验/NCT05976854
NCT05976854已完成不适用

Effects of an Online Intervention Based on Pain Neuroscience Education for Women with Pregnancy-related Lumbopelvic Pain

Cardenal Herrera University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.

详细描述

60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial origin makes it difficult to establish an appropriate treatment for pain control. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. This type of education is based on reconceptualizing pain through teaching the neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in pregnant women with pregnancy-related low back and pelvic pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women older than 18 years, who are in the early third trimester of pregnancy;
  • minimum score of 3/10 on the numerical pain scale over the past week.

排除标准

  • multiple pregnancy;
  • previous spinal surgery;
  • presence of psychiatric disorders;
  • women who have participated in similar programs or interventions before enrollment.

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 \[no pain\] to 10 \[worst pain imaginable\]).

次要结局

  • Disability(4 weeks)
  • Kinesiophobia(4 weeks)
  • Pain catastrophizing(4 weeks)
  • Anxiety and depression(4 weeks)
  • Level of physical activity(4 weeks)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan F. Lisón Párraga, Dr

Professor

Cardenal Herrera University

研究点 (2)

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