The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Conditions
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Cramps, Muscle Cramp

Intervention / Treatment
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* Behavioral: Behavioral intervention one
* Behavioral: Behavioral intervention two


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral intervention one<br> | Behavioral: Behavioral intervention one<br>* Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.<br>|
| Experimental: Behavioral intervention two<br> | Behavioral: Behavioral intervention two<br>* Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps | This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable. | baseline, 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global impression of change (PGIC) | This is a one question survey in which the participants rate overall status as one of the following: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. Comparison of PGIC scores at 35 days between both arms. | 35 days | 
| Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). | This is a one question survey in which the participants rate overall sleep quality as one of the following: Very good, Good, Fair, Bad, Very bad. | baseline, 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nighttime muscle cramps, Cirrhosis, Liver disease, Qualify of life, Sleep, Non-Pharmaceutical intervention