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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT04650295
Collaborator
(none)
82
1
2
10.4
7.8

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
  • Other: Household Remedy
  • Other: Tap water
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Actual Study Start Date :
Jan 18, 2021
Actual Primary Completion Date :
Dec 2, 2021
Actual Study Completion Date :
Dec 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Household Remedy

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.

Placebo Comparator: Tap Water

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Number of cramp-days per person [28 days]

  2. 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).

  3. Number of cramps during study [28 days]

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Elliot B. Tapper, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT04650295
Other Study ID Numbers:
  • HUM00185598
First Posted:
Dec 2, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elliot B. Tapper, Assistant Professor of Internal Medicine, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021