A Randomised, Double-blind, Evaluation of the Effects of Paracetamol on the BOLD fMRI Response to Painful Stimuli in Subjects With Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]
研究概览
简要总结
Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.
详细描述
The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of osteoarthritis of at least one knee for 3 months
- •Male or female at least 45 years of age
- •Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening
排除标准
- •If female, is pregnant, lactating, or breast feeding
- •Has secondary cause of knee arthritis
- •Lower extremity surgery in the last 6 months
- •Prior injury in the last twelve months to the index knee
- •Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start
- •Recently used oral or injected glucocorticoids
研究组 & 干预措施
Paracetamol caplets
Two 665 mg sustained release paracetamol caplets administered orally with water.
干预措施: Paracetamol (Drug)
Placebo caplets
Two placebo caplets administered orally with water.
干预措施: Placebo (Drug)
结局指标
主要结局
Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]
时间窗: Baseline to 2-5 hours post last dose administration
BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.
次要结局
- BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)](Baseline to 2-5 hours post last dose administration)
- Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)](Baseline and post-dose before stimulus)
- Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)](Baseline and post-dose pre-scan after stimulus)
- Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)](Baseline and post-dose pre-scan after stimulus)
- Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)](Baseline and post-dose post-scan after stimulus)
- Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)](Baseline and post-dose post-scan after stimulus)