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

Primary Purpose

Cramps, Muscle Cramp

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral intervention one
Behavioral intervention two
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cramps focused on measuring Nighttime muscle cramps, Cirrhosis, Liver disease, Qualify of life, Sleep, Non-Pharmaceutical intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai
  • University of Miami Health System
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Mayo Clinic
  • Baylor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Behavioral intervention one

Behavioral intervention two

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 9, 2022
Last Updated
September 8, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05457322
Brief Title
The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
Acronym
RELAX
Official Title
The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cramps, Muscle Cramp
Keywords
Nighttime muscle cramps, Cirrhosis, Liver disease, Qualify of life, Sleep, Non-Pharmaceutical intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral intervention one
Arm Type
Experimental
Arm Title
Behavioral intervention two
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention one
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention two
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps
Description
This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.
Time Frame
baseline, 35 days
Secondary Outcome Measure Information:
Title
Patient global impression of change (PGIC)
Description
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.
Time Frame
35 days
Title
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).
Description
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.
Time Frame
baseline, 35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: liver biopsy, or history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Baylor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

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