The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Muscle Cramp Clinical Trial

— RELAX  

Official title:

The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457322
• Other study ID #: HUM00216488
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cramps
• Muscle Cramp
• Spasm

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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