Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Change in Pain Levels
研究概览
简要总结
This blinded randomized comparative trial aims to determine the effectiveness of a customized Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in: a) reducing pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in pregnant women with PGP, c) improving quality of life for pregnant women with PGP d) cost effectiveness.
详细描述
Pelvic girdle pain (PGP) occurs in an estimated 70% of pregnant women, of whom 25% have severe pain and 8% significant disability. Current methods of management, such as the use of rigid pelvic belts, are limited in their effectiveness. The Dynamic Elastomeric Fabric Orthoses (DEFO) has recently proven beneficial in managing PGP in athletes. There is a need to explore the potential use of DEFO for managing PGP during pregnancy. The primary aim of the study is to compare the effectiveness of a DEFO to a rigid 'off the shelf' pelvic support belt in terms of its effectiveness in reducing PGP during pregnancy. The secondary aims of the study are to compare the effectiveness of the DEFO to the rigid 'off the shelf' pelvic support belt in (a) optimizing activity levels in pregnant women with PGP, (b)improving quality of life for pregnant women with PGP. The relative cost effectiveness of these two interventions will also be compared.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 20-36 weeks pregnant, who:
- •report intermittent PGP (commenced or aggravated during pregnancy) which causes walking and/or stair climbing to be bothersome and
- •are positive on at least 3 out of 7 pain provocation tests
排除标准
- •recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory, infective, traumatic, neoplastic, degenerative or metabolic, i.e. trauma, unexplained weight loss, history of cancer, steroid use, drug abuse, HIV infection, immunosuppressed state, neurological symptoms/signs such as: bowel, bladder, sensory, motor, reflex involvement (cauda equina, lumbar disk lesion, spinal stenosis,)
- •systemically unwell
- •obstetric complications
- •pain that does not improve with rest/severe disabling pain
- •history of chronic back or pelvic pain requiring surgery
- •focal inflammatory signs/tenderness of spine (spondylolisthesis)
- •known skin allergy to lycra
- •>36 weeks pregnant (production of customized DEFO will take approximately 1 week)
结局指标
主要结局
Change in Pain Levels
时间窗: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.
次要结局
- Change in Activity Levels(Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum))
- Change in Quality of Life(Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum))
研究者
Jenny Freeman
Associate Professor (Reader) in Physiotherapy
University of Plymouth