The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps (RELAX)

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.

Study Overview

• Status: Completed
• Conditions: Muscle Cramp; Cramps
• Intervention / Treatment: Behavioral: Behavioral intervention one; Behavioral: Behavioral intervention two

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Nikirk; Phone Number: 734-232-4182; Email: samjwalk@med.umich.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral intervention one	Behavioral: Behavioral intervention one; 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.
Experimental: Behavioral intervention two	Behavioral: Behavioral intervention two; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient global impression of change (PGIC)	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.	35 days
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).	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.	baseline, 35 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elliot Tapper, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Cirrhosis; Liver disease; Nighttime muscle cramps; Qualify of life; Non-Pharmaceutical intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Spasm; Muscle Cramp
• Other Study ID Numbers: HUM00216488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No