The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 12
- 主要终点
- Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
研究概览
简要总结
The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis.
Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.
详细描述
The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.
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
- •Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
- •Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
- •For Cirrhosis patients only: diagnosis of cirrhosis based upon:
- •liver biopsy, or
- •history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
- •2 of the following 4 criteria:
- •Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- •FibroScan liver stiffness score >13 kilopascal (kPa)
- •Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0
- •CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
排除标准
- •Non-English speaking
- •Unable or unwilling to provide consent
- •Pregnancy via self-report
- •Disorientation at the time of enrollment
- •History of multiple sclerosis
- •History of cerebral palsy
- •History of stroke with paralysis
结局指标
主要结局
Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
时间窗: baseline, 35 days
This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.
次要结局
- Patient global impression of change (PGIC)(35 days)
- Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).(baseline, 35 days)
研究者
Elliot B. Tapper
Associate Professor of Internal Medicine
University of Michigan