Clinical trial NCT05457322: The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
Official title: The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cramps
Muscle Cramp
Keywords: Nighttime muscle cramps
Cirrhosis
Liver disease
Qualify of life
Sleep
Non-Pharmaceutical intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

  1. liver biopsy, or
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
  3. 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

Primary outcomes:
measure: Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
timeFrame: baseline, 35 days
Secondary outcomes:
measure: Patient global impression of change (PGIC)
timeFrame: 35 days
measure: Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: baseline, 35 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Dallas
country: United States
facility: Baylor
state: Texas
Study officials:
affiliation: University of Michigan
name: Elliot Tapper, MD
role: PRINCIPAL_INVESTIGATOR
References: