Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Neurophysiological measures
研究概览
简要总结
The purpose of the study is to identify non-invasive strategies that will optimize the neurobiological environment and improve learning and memory in the treatment of chronic pain. The overall aims of the current proposal are to determine if food restriction and/or glucose administration in conjunction with a relaxation/guided imagery exercise will result in neurophysiological changes and functional improvements compared to the relaxation/guided imagery exercise alone.
详细描述
Up to sixty adults with chronic knee pain with or/at risk of knee osteoarthritis will be randomized to one of three groups: food restriction (20 participants), glucose administration (20 participants), or control (20 participants). Participants will attend four sessions over a two to three week period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with chronic knee pain with or/at risk of knee osteoarthritis
排除标准
- •Concurrent medical condition that could confound outcome measures or limit the ability to participate completely in the protocol including: neurological conditions (Parkinson's disease, multiple sclerosis, and/or seizures)
- •History of a head injury or stroke
- •Diabetes or taking medications to control blood sugar
- •Mental health issues resulting in hospitalization or outpatient treatment in the past year, and/or psychotropic medication use
- •Current issue or history of treatment for alcohol or other substance abuse
- •Cognitive function < or = 22 on the Mini-Mental Status Exam
- •Pregnancy
- •A baseline fasting blood sugar (plasma glucose > 7mmol/L) or persisting blood pressure >150/
- •Heart condition such as a prior heart attack, heart surgery (including a stent), frequent chest pain or heart failure
- •Inability to complete the EEG portion of the study
研究组 & 干预措施
Control
For sessions 2 through 4, maintain normal eating patterns.
干预措施: Control (Other)
Glucose Administration
For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.
干预措施: Glucose Administration (Other)
Intermittent Fasting
For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).
干预措施: Intermittent Fasting (Other)
结局指标
主要结局
Change in Neurophysiological measures
时间窗: baseline and 3 weeks
Electroencephalogram (EEG) amplitude measures.
次要结局
- Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli(baseline and 3 weeks)
- Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline and 3 weeks)
- Change in Level of Distress measure - Perceived Stress Scale(baseline and 3 weeks)
- Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)(baseline and 3 weeks)