Cirrhosis Clinical Trial
Official title:
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Verified date | December 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | December 2, 2021 |
Est. primary completion date | December 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of cramp-days per person | 28 days | ||
Secondary | 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 | |
Secondary | Number of cramps during study | 28 days | ||
Secondary | 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 |
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