The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Not Applicable

Completed

• Conditions: Muscle Cramp; Cramps
• Interventions: Behavioral: Behavioral intervention one; Behavioral: Behavioral intervention two

• Registration Number: NCT05457322
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-14
• Study Start: 2022-08-30
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention one	Behavioral intervention one	-
Behavioral intervention two	Behavioral intervention two	-

Primary Outcome Measures

Name	Time	Method
Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps	baseline, 35 days	This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.

Secondary Outcome Measures

Name	Time	Method
Patient global impression of change (PGIC)	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.
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).	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.

Trial Locations

Locations (6)

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Miami Health System; 🇺🇸 Miami, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Baylor; 🇺🇸 Dallas, Texas, United States