Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial

Study Overview
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Brief Summary
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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.

Official Title
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Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial

Conditions
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Cirrhosis, Muscle Cramp, Ascites

Intervention / Treatment
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* Other: Household Remedy
* Other: Tap water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

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: Household Remedy<br> | Other: Household Remedy<br>* If the participant experiences a muscle cramp one tablespoon (one sip) of the household product will be taken. The treatment phase of the study will be for 28 days.<br>|
| Placebo Comparator: Tap Water<br> | Other: Tap water<br>* If the participant experiences a muscle cramp one tablespoon (one sip) of tap water will be taken. The treatment phase of the study will be for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps | This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cramp-days per person |  | 28 days | 
| Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps | This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable). | 28 days | 
| Number of cramps during study |  | 28 days | 
| Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) | This study uses one question from the Pittsburgh Sleep Quality Index (PSQI) in which the participants reply how their sleep quality during the past month has been. Responses include: Very Good (0), Good (1), Fair (2), Bad (3), and Very Bad (4) the higher the score the worse the quality of sleep. | baseline, 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver disease, Nutrition, quality of life, sleep, non-pharmaceutical intervention