The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

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University of Michigan

Status

Completed

Conditions

Muscle Cramp
Cramps

Treatments

Behavioral: Behavioral intervention two
Behavioral: Behavioral intervention one

Study type

Interventional

Funder types

Other

Identifiers

NCT05457322
HUM00216488

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No 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:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

99 participants in 2 patient groups

Behavioral intervention one
Experimental group
Treatment:
Behavioral: Behavioral intervention one
Behavioral intervention two
Experimental group
Treatment:
Behavioral: Behavioral intervention two

Trial contacts and locations

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Central trial contact

Samantha Nikirk

Data sourced from clinicaltrials.gov

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