The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Pain intensity
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia
详细描述
All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
- •Chronic widespread musculoskeletal pain symptoms (>1 location using the Widespread Pain Index).
- •High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
- •If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
- •Over 18 and less than 65 years old (labour active).
- •Ability to speak and understand English or Spanish.
排除标准
- •Acute or temporal pain
- •Severe cognitive impairment, detected by the Mini-Mental State Examination (score <24 out of 30 points)
- •Severe mental disorders in acute phase or symptomatic phase
- •Behavioural alterations as this may interfere in their participation
- •Severe intellectual disability
- •Other severe or medically unstable diseases interfering with the project participation
- •Co-occurrence of neuropathic pain
- •Other disorders that may cause pain
- •Pregnant or breast-feeding
- •Drug abuse within the past year.
结局指标
主要结局
Pain intensity
时间窗: Change from baseline pain intensity after 30 minutes
Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10
Cold pain thresholds
时间窗: Change from baseline cold pain thresholds after 30 minutes
Cold pressor test will be used
Punctate mechanical hyperalgesia
时间窗: Change from baseline mechanical hyperalgesia after 30 minutes
Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used
Wind-up phenomenon
时间窗: Change from baseline temporal summation of pain perception after 30 minutes
Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception.
Pressure pain thresholds
时间窗: Change from baseline pressure pain thresholds after 30 minutes
The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold
次要结局
未报告次要终点
研究者
José Manuel Pérez Mármol
Principal Investigator / Associate professor
Universidad de Granada