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NCT Number: NCT04650295

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

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.

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Key information

Conditions

Cirrhosis Ascites Digestive System Diseases Fibrosis Liver Diseases Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps

    Time frame: 28 days

    This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).

Secondary outcomes

  1. Number of cramp-days per person

    Time frame: 28 days

  2. Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps

    Time frame: 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

    Time frame: 28 days

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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