Evaluating the Management of Chronic Pelvic Girdle Pain Following Pregnancy (EMaPP): A Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline pain intensity (Numerical Rating Pain Scale) at 24 weeks
研究概览
简要总结
Evaluating the Management of chronic Pelvic girdle pain following Pregnancy (EMaPP)
During pregnancy pelvic girdle pain is common. This pain will often reduce following childbirth, however almost 20% of women continue to suffer significant pain for at least three months afterwards. When pain is severe it will affect everyday activities and quality of life. Usual treatment typically involves Physiotherapy (advice and exercise) and provision of an "off the shelf" rigid pelvic support belt. Women often find these uncomfortable and difficult to use. A customised pelvic orthotic (referred to as pelvic support shorts) is an alternative that on initial testing has shown promising results in women with chronic pelvic girdle pain.This feasibility study aims to obtain the data and operational experience necessary to inform the conduct and finalise the design of a future large randomised controlled trial. The investigators will also gather women's views about the support shorts and the trial. It is vital to understand what treatments are beneficial to this group of women and this is the main driver for this National Institute of Health Research funded trial.
Following screening and consent, 60 women aged > 18 years, with severe, persistent post-partum pelvic girdle pain will be recruited into the trial. They will be randomised to receive either usual care (advice and exercise) or usual care and the customised pelvic support shorts. All women will receive 2 web-based sessions with a physiotherapist who will provide this intervention. All will complete web-based self-report questionnaires (pain, function, quality of life, continence, depression) at baseline, 3 and 6 months. Fortnightly scoring of pain and medication usage throughout the trial timeline complements this. Fifteen women and five clinicians will be interviewed at the end of the trial to explore their experiences of wearing/providing the "support shorts" and participating in the trial.
详细描述
The investigators will undertake a multi-centre feasibility RCT, randomising participants to receive either the "pelvic support shorts" plus standardised information and exercises (intervention) or standardised information and exercises alone (control).
The investigators will recruit 60 women from the South West of England who are experiencing chronic (≥3 months) and severe pelvic girdle pain following pregnancy.
Following screening and consent, baseline assessment will be undertaken using a range of patient-reported measures: pain, depression, continence, function, quality of life, health/social care and patient resource use. Women will randomly allocated to intervention or control. Two weeks following randomisation, all participants will attend a physiotherapy session via web-conference to receive standardised information and suggested exercises. In addition, intervention group participants will receive two pairs of the pelvic support shorts. In line with usual physiotherapy practice, all participants will receive a follow-up review session via web-conference, approximately 10 days later.
Throughout the study timeframe, medication usage and pain rating scale scores will be completed by the women, on a fortnightly basis, via web-based self-report questionnaires. Additionally, at 12 and 24 weeks all baseline patientreported measures will again be collected. A qualitative sub- study, involving interviews (telephone or web-based) will explore participant experiences of wearing (patient) and providing (physiotherapists) the support shorts, and of the study itself.
The Population
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
All outcomes measures are collected via self report means. This will enable the investigators to be blinded to the outcomes measures reported. Treating clinicians are also blinded to the outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged greater than or equal to 18
- •Able and willing to provide informed consent
- •Self reported Persistent pelvic girdle pain (PGP) (≥3 months post partum)
- •Self reported severe PGP (causing walking or stair climbing to be bothersome)
- •Diagnosed with PGP in line with European guidelines
- •PGP must have started or been aggravated during pregnancy, as determined by self report
排除标准
- •known allergy to lycra
- •age < 18
- •currently pregnant
- •PGP for > 2 years post partum
- •Self reported history of pathologies causative of lumbo pelvic pain(e.g. Infection, trauma, cancer)
- •Participating in concurrent interventional research which may over-burden the patient or confound data collection
- •There are no special arrangements made for participants who are unable to adequately understand verbal and/or written English. There is no intention to exclude patients, therefore, if they have regular access to a friend or family member who is able to translate for them they would be able to participate
- •Participants who lack capacity to provide informed consent
结局指标
主要结局
Change from baseline pain intensity (Numerical Rating Pain Scale) at 24 weeks
时间窗: up to 24 weeks
Numerical pain rating scale. This is to assess pain levels across the course of the study period of 24 weeks. Women will be asked to rate their pain experience over the past fortnight, using the NPRS, in four categories: * Worst level of pelvic pain during the day * Average level of pelvic pain during the day * Worst level of pelvic pain during the night * Average level of pelvic pain during the night Scale runs between 0-10. Higher scores represent greater pain intensity.
次要结局
- iciq-ui sf(Baseline, 12 weeks, 24 weeks)
- SF36(Baseline, 12 weeks, 24 weeks)
- Support shorts wear time(24 weeks)
- Health resource use questionnaire(Baseline, 12 weeks, 24 weeks)
- Pelvic girdle questionnaire(Baseline, 12 weeks, 24 weeks)
- EPDS(Baseline, 12 weeks, 24 weeks)
- EQ-5D-5L(Baseline, 12 weeks, 24 weeks)
研究者
Bradley Halliday
Teaching and research associate
University of Plymouth