Effects of a Motor Control Exercise Program on Lumbopelvic Pain Occurrence and Intensity in Pregnant Women With a History of Lumbopelvic Pain: a Study Protocol for a Randomized Controlled Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Adherence rate
研究概览
简要总结
This study protocol was designed to establish the feasibility of conducting a motor control exercise program with pregnant women presenting a history of lumbopelvic pain (LBPP) in order to reduce LBPP occurrence or limit its intensity. This randomized controlled trial also aims to preliminary assess the effectiveness of the program. To do so, 40 pregnant women with a history of LBPP will be recruited and randomly allocated to one of 2 groups: control (20 participants) or intervention (20 participants). The control group will receive standard care, including basic information on what to do when suffering from LBPP. The intervention group will participate in a weekly 40-minute group session and two more 40-minute weekly home exercise sessions. The motor control exercise program will be designed to target strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and protection of the spine and pelvis. Participants of this group will also receive standard care. Adequate prevention and treatment of LBPP, experienced by women during pregnancy, should help reduce LBPP occurrence or limit its intensity during pregnancy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being pregnant of one fetus
- •Being ≤ 20 weeks pregnant
- •Presenting a history of lumbopelvic pain
排除标准
- •Inflammatory rheumatic disease
- •Infectious disease
- •Neuromuscular disease
- •Vascular disease
- •Connective tissue disease
- •Severe disabling pain
- •Neurologic signs and symptoms
结局指标
主要结局
Adherence rate
时间窗: Baseline (Post-intervention)
Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Acceptability of the intervention
时间窗: Week 16 (Post-intervention)
Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)
Retention rate
时间窗: Baseline (Post-intervention)
Defined as the completion of follow-up questionnaire by ≥ 80% of women
Safety of the intervention
时间窗: Week 16 (Post-intervention)
Determined based on the number of adverse events and defined as nature of adverse events
Recruitment rate
时间窗: Baseline (Pre-intervention)
Defined as the ability to recruit 40 eligible women, willing to participate to the study
次要结局
- Depression(Baseline (Pre-intervention) and week 16 (Post-intervention))
- Lumbopelvic pain (incidence and frequency)(Week 16 (Post-intervention))
- Lumbopelvic pain (intensity)(Week 16 (Post-intervention))
- Functional disability(Baseline (Pre-intervention) and week 16 (Post-intervention))
- Fear avoidance behaviors(Baseline (Pre-intervention) and week 16 (Post-intervention))
- Level of anxiety(Baseline (Pre-intervention) and week 16 (Post-intervention))
- Physical activity levels(Baseline (Pre-intervention) and week 16 (Post-intervention))
研究者
Martin Descarreaux
Principal investigator
Université du Québec à Trois-Rivières