Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Changes in Pain Perception
研究概览
简要总结
This clinical investigation will be carried out as a randomized controlled trial conducted at the Northern Regional Hospital, Hjørring. This investigation will enrol 36 patients suffering from severe knee osteoarthritis pain, primarily from the orthopaedic ward at Hjørring Hospital, where potential participants will be identified during routine consultations.
The RELEARN intervention consists of encephalography (EEG) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception. This investigation is carried out to analyse the clinical performance and safety of the RELEARN neurofeedback software.
详细描述
The participants will be randomized into treatment group A and control group B, 1:1 and be stratified based on age, sex, and ethnicity. Group A participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session, and group B participants will be asked to attend eight sessions with no intervention and serve as no-treatment controls with an approximate duration of 5 minutes per session. Both groups (A and B) will undergo three follow-up sessions: one month, three months, and five months post intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
- •24h VAS ≥ 4
- •Ongoing pain, lasting more than three months
排除标准
- •Participants who meet any of the below criteria will be excluded from the investigation:
- •Pregnant or lactating woman
- •Use of opioids or cannabis
- •Active drug addiction defined as the use of cannabis, opioids, or other drugs
- •Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease.
- •Rheumatoid arthritis
- •Evidence of other pain types such as visceral, neuropathic, or malignant pain.
- •Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation
- •Severe inflammation in the area of interest
- •Blindness or deafness
- •Consumption of alcohol, caffeine, nicotine on test day
- •Recent history of fractures or surgery in the area of interest
- •Participation in other clinical trials throughout the study period and one month prior to participation
- •History of epilepsy
- •Obesity class III and above. I.e. BMI > 39,9
结局指标
主要结局
Changes in Pain Perception
时间窗: Up to 6 month
Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)
次要结局
- Change in consumption of analgesics(Up to 6 month)
- Change in quality of life(Up to 6 month)
- Change in pain characteristics(Up to 6 month)
- Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies(Up to 6 month)