Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Largest Change From Baseline on Clinical Pain Rating
研究概览
简要总结
This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.
详细描述
This study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. Subjects will complete two screening sessions before completing four study sessions that will occur once weekly. Participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Within-subjects design. Two pills will be administered at each study visit. Participants and study staff will be blind to the drug(s) administered.
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 knee osteoarthritis
- •Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
- •Medically cleared to take study medications
- •Are not pregnant or breast feeding
- •Willing to comply with the study protocol.
排除标准
- •Pain other than Knee Osteoarthritis
- •Taking opioids for pain
- •Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
- •Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
- •Known allergy to the blinded study medications
研究组 & 干预措施
Arm 1
Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
干预措施: Blinded study medication (Drug)
Arm 2
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
干预措施: Blinded study medication (Drug)
Arm 3
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
干预措施: Blinded study medication (Drug)
Arm 4
Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
干预措施: Blinded study medication (Drug)
结局指标
主要结局
Largest Change From Baseline on Clinical Pain Rating
时间窗: 8 hour study session
The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.
次要结局
未报告次要终点