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Completed

NCT Number: NCT05457322

The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis.

Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.

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Key information

Conditions

Cramps 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

Cedars-Sinai, Los Angeles, California, United States

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About this study

The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
  • Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
  • For Cirrhosis patients only: diagnosis of cirrhosis based upon:
  • liver biopsy, or
  • history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
  • 2 of the following 4 criteria:
  • Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
  • FibroScan liver stiffness score >13 kilopascal (kPa)
  • Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0
  • CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

Exclusion criteria

  • Non-English speaking
  • Unable or unwilling to provide consent
  • Pregnancy via self-report
  • Disorientation at the time of enrollment
  • History of multiple sclerosis
  • History of cerebral palsy
  • History of stroke with paralysis

Treatment and study plan

Behavioral intervention one

Behavioral

Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.

Behavioral intervention two

Behavioral

Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.

Primary outcomes

  1. Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps

    Time frame: baseline, 35 days

    This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.

Secondary outcomes

  1. Patient global impression of change (PGIC)

    Time frame: 35 days

    This is a one question survey in which the participants rate overall status as one of the following:

    Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. Comparison of PGIC scores at 35 days between both arms.

  2. Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).

    Time frame: baseline, 35 days

    This is a one question survey in which the participants rate overall sleep quality as one of the following: Very good, Good, Fair, Bad, Very bad.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: RELAX

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Sep 11, 2023

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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