Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps
研究概览
简要总结
This clinical trial is evaluating the feasibility of using a non-pharmaceutical treatment to improve the symptoms and severity of muscle cramps in patients with cirrhosis.
Eligible participants will be randomized to the treatment arm or control group. The treatment phase of the study will last 28 days. Information about participants will be collected including surveys and assessments throughout the study. Please note that only the participants randomized to experimental intervention group (Household Remedy) will be told what the treatment is during the study period. At the conclusion of the study (time of the final follow-up assessments), all participants will be debriefed on the use of concealment in this study as outlined in the protocol regarding the 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cirrhosis (criteria per protocol will be used)
- •History of painful muscle spasms, cramps, or charley horses that come on while resting (they had to have happened 4 times in the past month and bother the participant)
排除标准
- •Non-English speaking
- •Unable or unwilling to provide consent
- •History of liver transplant
- •History of multiple sclerosis
- •History of cerebral palsy
- •History of stroke with paralysis
结局指标
主要结局
Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps
时间窗: 28 days
This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
次要结局
- Number of cramps during study(28 days)
- Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps(28 days)
- Number of cramp-days per person(28 days)
- Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)(baseline, 28 days)
研究者
Elliot B. Tapper
Assistant Professor of Internal Medicine
University of Michigan