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

Primary Purpose

Cirrhosis, Muscle Cramp, Ascites

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Household Remedy
Tap water
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Liver disease, Nutrition, quality of life, sleep, non-pharmaceutical intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Household Remedy

Tap Water

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of cramp-days per person
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).
Number of cramps during study
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.

Full Information

First Posted
November 24, 2020
Last Updated
December 2, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04650295
Brief Title
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Official Title
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Muscle Cramp, Ascites
Keywords
Liver disease, Nutrition, quality of life, sleep, non-pharmaceutical intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Household Remedy
Arm Type
Experimental
Arm Title
Tap Water
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Household Remedy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tap water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps
Description
This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of cramp-days per person
Time Frame
28 days
Title
Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps
Description
This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
Time Frame
28 days
Title
Number of cramps during study
Time Frame
28 days
Title
Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
baseline, 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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