A Neurofeedback Treatment for Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study evaluates the effects of a novel neurofeedback treatment on pain specific brainwaves in adults.
Chronic pain patients enrolled in this study will be randomized into a treatment group and a sham group.
详细描述
Recent research has underlined that central nervous system structures play a key role in the development of pain with significant maladaptive plasticity occurring in several brain areas. Non-pharmacological treatments, such as neurofeedback, are designed to restore normal brain function alongside with relieving pain symptoms. With a neurofeedback approach, the patient is provided with a feedback on specific brain waves recorded using non-invasive recording techniques (electroencephalography - EEG) and visualized on a screen.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from chronic pain due to tennis elbow for at least 3 months
- •A clinical diagnosis of chronic lateral epicondylalgia,
- •Pain associated with functional activities such as gripping and pain with resisted contraction of the wrist extensors or extensor carpi radialis brevis, or with passive stretching of the wrist extensors.
排除标准
- •Clinical diagnosis of chronic lateral epicondylalgia on both sides, cervicothoracic spinal pathology, other upper limb musculoskeletal disorders or neurological disorders
- •Pregnancy
- •Drug addiction defined as the use of cannabis, opioids or other drugs
- •Previous or current neurologic, musculoskeletal or mental illnesses defined as an on-going systemic condition
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial e.g. analgesics, anti- inflammatory drugs
- •Consumption of alcohol, caffeine, nicotine or painkillers throughout the study period
- •Past history of chronic pain, neurological or psychiatric conditions
- •Participation in other pain trials throughout the study period and one month prior to participation
- •Participation in more than two sessions of muscle training exercises per week involving the upper limb and/or lower back
- •Evidence of other sources of elbow pain such as exacerbation of pain with neck movement or manual examination
- •Sensory disturbances
- •History of fractures
- •Elbow surgery
- •Contraindications to the use of TMS
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Up to three months
Numerical pain scale ranging from 0 being no pain to 10 being worst imaginable pain (significant change in VAS score will be set to 1 at P = 0.05)
次要结局
- Electromyographic (EMG) measurement.(Up to three months)
- Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested.(Up to three months)
研究者
Natalie Mrachacz-Kersting
Associate Professor
Aalborg University