Efficacy of an Online Pain Neuroscience Education Intervention in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Pain intensity measured by the 11-point Numeric Rating Scale (NRS)
研究概览
简要总结
Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Pain neuroscience education (PNE) has shown positive effects in musculoskeletal conditions but has not yet been studied in women with primary dysmenorrhea. This study aims to evaluate the effect of an online PNE intervention combined with lifestyle recommendations, compared to lifestyle recommendations alone
详细描述
This randomized controlled trial will compare an online pain neuroscience education (PNE) program plus lifestyle recommendations with lifestyle recommendations alone in women with primary dysmenorrhea. Participants will be randomized (1:1) to either the intervention group (4-week online PNE modules plus lifestyle recommendations) or the control group (lifestyle recommendations only). The program is based on Butler and Moseley's pain neuroscience principles, adapted to menstrual pain. Outcomes will be assessed at baseline and at 6 months. The primary outcome is pain intensity. Secondary outcomes include anxiety, depression, kinesiophobia and pain catastrophizing,
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)
盲法说明
Outcome assessors and data analysts will be blinded to group allocation. Participants and intervention providers will not be masked due to the nature of the educational program. Allocation will be concealed using a computer-generated randomization sequence managed by an independent researcher.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women aged 18 to 35 years.
- •Clinical diagnosis of primary dysmenorrhea.
- •History of moderate to severe menstrual pain for at least six consecutive menstrual cycles.
- •Pain intensity score greater than 5 on a numerical rating scale (0-10).
- •No prior use of pain neuroscience education (PNE).
- •No history of pregnancy.
排除标准
- •History of lower abdominal surgery.
- •Presence of severe mental health disorders.
- •Current use of hormonal contraceptives.
研究组 & 干预措施
Online Pain Neuroscience Education (PNE)
Participants in this arm will receive an online pain neuroscience education (PNE) program plus usual lifestyle recommendations. The PNE intervention consists of four weekly audiovisual and written modules adapted to the context of primary dysmenorrhea, focusing on the neurobiology and biopsychosocial aspects of pain, with practical strategies to reduce maladaptive beliefs, kinesiophobia, and catastrophizing.
干预措施: PNE online + lifestyle recommendations. (Other)
Active Comparator
Participants in this arm will receive the usual lifestyle recommendations for primary dysmenorrhea. These recommendations include general advice on healthy habits and self-management strategies typically provided in clinical practice.
干预措施: Lifestyle recommendations (Other)
结局指标
主要结局
Pain intensity measured by the 11-point Numeric Rating Scale (NRS)
时间窗: pre-intervention and 6 months post-intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average menstrual pain intensity over the previous cycle, from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
次要结局
- Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)(pre-intervention and 6 months post-intervention)
- Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)(pre-intervention and 6 months post-intervention)
- Kinesiophobia measured by the Tampa Scale for Kinesiophobia-11 (TSK-11)(pre-intervention and 6 months post-intervention)
研究者
Juan F. Lisón Párraga, Dr
Dr
Cardenal Herrera University