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

NCT04650295 | Completed

• 1 other identifier: HUM00185598
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Muscle Cramp; Ascites

Keywords

Liver disease; Nutrition; quality of life; sleep; non-pharmaceutical intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Number of cramps during study

  28 days

• Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)

  baseline, 28 days

Study Arms (2)

Household Remedy

EXPERIMENTAL

Other: Household Remedy

Tap Water

PLACEBO COMPARATOR

Other: Tap water

Interventions

Household Remedy OTHER

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.

Household Remedy

Tap water OTHER

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.

Tap Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Fibrosis; Muscle Cramp; Ascites; Liver Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Digestive System Diseases

Study Officials

• Elliot Tapper, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 18, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)