NCT04220567Unknown不适用
Is a Combined Programme of Exercise and Patient-centred Education More Effective Than Exercise Alone in Individuals With Fibromyalgia? A Randomised Controlled Trial
Instituto Politécnico de Setúbal. Escola Superior de Saúde.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
This study aims to compare the effects of an eight-week exercise and patient-centred education programme with eight-week exercise alone programme on disability, pain intensity, health-related quality of life and patient global impression of change.
A prospective, parallel, double-blinded and multi-centre randomised controlled trial will be carried out.
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)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)
排除标准
- •Presence of uncontrolled medical disorders (cardiovascular/ metabolic/ neurological/ renal)
- •Presence of active oncological disease (or until 5 years and undergoing treatment)
- •Presence of inflammatory rheumatic diseases other than fibromyalgia
- •Presence of inflammatory osteoarticular disease or severe osteoarthritis (grade IV de Kellgren - Lawrence Classification of Osteoarthritis)
- •Previous orthopaedic (column or lower limb) or cardiothoracic surgery in the year before;
- •Disability not compatible with the exercise practice required
- •Pregnancy
- •Attendance to a physiotherapy programme including exercise in the previous three months
- •Difficulty in written communication that prevent the fulfilment of self-reported questionnaires.
结局指标
主要结局
Pain intensity
时间窗: Follow-up 3 months
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Disability and Impact of Fibromyalgia
时间窗: Follow-up 3 months
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
次要结局
- Neuropathic components in pain(Baseline)
- Patients' perception of improvement or decline in clinical status(Follow-up 3 months)
- Health-related Quality of Life(Follow-up 3 months)
研究者
研究点 (2)
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