Catastrophizing and Virtual Reality's Impact on the Pain Threshold During a Cold Pressor Test in Patients With Fibromyalgia: A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand, read and speak Danish
- •Able to independently answer a questionnaire
- •Able to give informed consent
- •Fibromyalgia group:
- •Confirmed diagnosed with fibromyalgia
- •Healthy participants
排除标准
- •Applies for both groups:
- •Signs of anxiety, depression and post-traumatic stress syndrome that require treatment
- •Neurologic, musculoskeletal or mental illnesses that could influence the results.
- •Parallel participating in other studies, that can influence this study
- •Pregnancy
- •Fibromyalgia group:
- •Regulation in medication
- •Anticonvulsivant use the last week
- •Serotonin-norepinephrine reuptake Inhibitor (SNRI) the last two weeks
- •Tricykliske antidepressants (TCA) the last four weeks
- •No regular use of pain medication
- •No current or previous history of subacute or ongoing pain
研究组 & 干预措施
Fibromyalgia
Individuals with fibromyalgia.
干预措施: Cold Pressor Test (Other)
Fibromyalgia
Individuals with fibromyalgia.
干预措施: Cold Pressor Test + Virtual Reality (Other)
Healthy controls
Healthy, pain-free individuals
干预措施: Cold Pressor Test (Other)
Healthy controls
Healthy, pain-free individuals
干预措施: Cold Pressor Test + Virtual Reality (Other)
结局指标
主要结局
Pain intensity
时间窗: through study completion, an average of 90minutes
Pain intensity during the interventions is scored using a Visual Analog Scale or Numeric Rating Scale (0 = no pain and 10 = worst known pain)
Pain threshold
时间窗: through study completion, an average of 90minutes
Pain threshold is defined as when the participants feel the sensation changing from an unpleasant feeling to a painful experience (measured in seconds)
Pain tolerance
时间窗: through study completion, an average of 90minutes
Pain tolerance is when the participants no longer are able to withstand the pain (measured in seconds).
次要结局
- Pain catastrophizing(through study completion, an average of 90minutes)
研究者
Steffan Wittrup Christensen
Associate professor
Aalborg University