Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Household Remedy
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Other: Household Remedy
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.
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Placebo Comparator: Tap Water
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Other: Tap water
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.
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Outcome Measures
Primary Outcome Measures
- 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
- Number of cramp-days per person [28 days]
- 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]
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of cirrhosis (criteria per protocol will be used)
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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:
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Non-English speaking
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Unable or unwilling to provide consent
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History of liver transplant
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History of multiple sclerosis
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History of cerebral palsy
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History of stroke with paralysis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Elliot Tapper, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00185598