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

Not Applicable

Completed

• Conditions: Muscle Cramp; Cirrhosis; Ascites
• Interventions: Other: Tap water; Other: Household Remedy

• Registration Number: NCT04650295
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-01-18
• Status Verified: 2021-12
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tap Water	Tap water	-
Household Remedy	Household Remedy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps	28 days	This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
Number of cramps during study	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	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States