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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650295
• Other study ID #: HUM00185598
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Muscle Cramp
• Spasm

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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