The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Completed · Not applicable

Conditions studied: Cramps, Muscle Cramp

In brief

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.

Key facts

Study ID

NCT05457322

Run by

University of Michigan

People needed

99

Starts

2022-08-30

Expected to finish

2023-08-14

Last updated by the study team

2023-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai — Los Angeles, California, United States
• University of Miami Health System — Miami, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Baylor — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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