Muscle Cramp Clinical Trial
— RELAXOfficial title:
The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
Verified date | September 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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 |
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