Neurofeeback for Chronic Pain Project (NFB Project)
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Changes in pain ratings
研究概览
简要总结
This study evaluates the effectiveness of neurofeedback (teaching participants to gain control over their own brainwaves) in chronic pain. The study is made up of four pilot studies. Participants who take part will undergo the cold pressor test, submerging their hand in cold water in order to simulate chronic pain. Brain activity will be measured using electroencephalography (EEG).
详细描述
Chronic pain is a persisting pain which often exists in the absence of detectable tissue damage. It is also associated with feelings of depression, anxiety, and despair. Current treatments for chronic pain usually involves drug treatments, which often has unwanted side effects.
This study aims to assess the effectiveness of neurofeedback, which refers to teaching participants to gain control over their own brainwaves, as an intervention to treat chronic pain. It is believed that by teaching participants to gain control over a brain signal associated with pain resilience, the participant can reduce some of the negative effects associated with chronic pain.
Participants who take part in this study will have their brain activity recorded using electroencephalography (EEG), and have pain elicited using the cold pressor test (CPT), which involves the participant submerging their wrist in cold water to elicit a chronic pain-like sensation. This is a safe, regularly used method, and the participant is free to remove their hand early if the pain becomes too great.
Some participants who take part will undergo neurofeedback training, which will involve them viewing a signal associated with pain resilience, and learning to increase it over multiple sessions.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A number of the studies include double-blind neurofeedback, where half of the participants receive sham neurofeedback, and half receive actual neurofeedback from a region thought to increase pain resilience. The experimenter, participant, and care provider will all be blinded as to which condition the participant is in until the participant leaves the study.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for participation in the study
- •Must be aged 40 or older
排除标准
- •Current or planned hospitalisation during the period of study.
- •Non-English speaking participants
- •Participants already involved in clinical trials, if it is not possible to schedule around this
- •Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study.
- •Patients with chronic pain in both upper limbs
- •History of brain injury, stroke or neurosurgical procedures
- •An implanted neurostimulator (e.g., deep brain stimulator)
- •Damaged skin tissue on the head, or a skin condition such as severe eczema, or any skin allergies
- •Failure of cognitive test (Montreal Cognitive Assessment) will exclude participants from taking part in studies that use neurofeedback procedures
- •Some but not all of the study will be unavailable to participants currently undergoing psychotherapy (such as cognitive behavioural therapy).
结局指标
主要结局
Changes in pain ratings
时间窗: Throughout the participant's time in the study, approximately 8-16 weeks. (16 sessions which occur approximately twice per week,depending on participant's availability.).
The investigators will monitor changes in pain ratings, which are ratings of current pain level, given on a scale from 0-10 using a Visual Analogue Scale (VAS). These ratings will be given by participants while undergoing the experimental procedures in the study.
次要结局
- Self-report: participant's own ratings of pain experienced(through study completion, an average of 12 weeks.)
- Questionnaire: Hospital Anxiety and Depression Scale(through study completion, an average of 12 weeks.)
- Questionnaire: Brief Pain Inventory(through study completion, an average of 12 weeks.)
- Questionnaire: Medical history(Administered at initial session, one day only)
- Questionnaire: PANAS (Positive and Negative Affect Schedule)(through study completion, an average of 12 weeks.)
- Assessment: Tender Points Survey(through study completion, an average of 12 weeks.)
- Changes in brain activity caused by neurofeedback procedures(Throughout the participant's time in the study, an average of 12 weeks.)
- Smartphone app measures of changes in of chronic pain-related symptoms(Throughout the participant's time in the study, an average of 12 weeks.)
- Questionnaire: Participant Demographics(Administered at initial session, one day only)
- Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire)(through study completion, an average of 12 weeks.)
- Questionnaire: EQ5D (developed by EuroQol group)(through study completion, an average of 12 weeks.)
- Questionnaire: McGill Short Form(through study completion, an average of 12 weeks.)
- Assessment: Montreal Cognitive Assessment(through study completion, an average of 12 weeks.)
- Questionnaire: Pain Catastrophizing Scale(through study completion, an average of 12 weeks.)
研究者
Anthony Jones
Clinical Professor
University of Manchester