Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dynamometer tests
研究概览
简要总结
The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.
For years, research has been conducted on the effects of dynamic plaster and rigid plaster on muscle function. In many cases, reports from different authors are contradictory. Therefore, the planned study will use placebo paper plaster with no proven therapeutic effect.
详细描述
People's words can have a huge impact on how we interpret our surroundings, what we expect and experience, and how we behave. The placebo (and nocebo) effects are a clear example here. The way health professionals discuss, describe and inform patients about the characteristic effects of a given disease, its prevention, diagnosis and treatment influences patients' feelings and expectations, which in turn affects their psychobiological responses, subjective feelings and treatment outcomes.
The right choice of words by clinicians influences patients' response to medical treatments and procedures, both active and sham. The way in which information about the effects of treatment is communicated to patients can reinforce the outcomes of a particular treatment (placebo) or reverse clinically-proven effects of an active treatment, or even increase its adverse effects. The right messages can reduce the nocebo effect. And vice versa, the wrong choice of information provided may increase the patient's anxiety and disease symptoms.
The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.
Main hypothesis:
The use of a positive message will have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
- •age - 19-24 years,
- •written consent to participate in the study.
排除标准
- •subjects studying for a degree in physiotherapy,
- •subjects post surgery on the examined upper limb,
- •subjects with past bone fractures in the examined upper limb,
- •subjects who have had an injury to the examined upper limb within 6 months before the start of the study.
研究组 & 干预措施
Positive message
Group A - 30 subjects who will be told that positive message.
干预措施: Positive message - placebo (Behavioral)
Negative message
Group B - 30 subjects who will be told negative message.
干预措施: Negative message - nocebo (Behavioral)
Neutral message
Group C - 30 people who will be told neutral message.
干预措施: Neutral message (Behavioral)
结局指标
主要结局
Dynamometer tests
时间窗: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
Assessment of wrist and finger flexor muscle strength. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The patient squeezes the dynamometer for a period of 3-5 seconds.
次要结局
- Testing with Naroxon Ultimum EMG(Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.)
研究者
Kamil Zaworski
Director
John Paul II University in Biała Podlaska