Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Status
Conditions
Treatments
Details and patient eligibility
About
This clinical trial is evaluating the feasibility of using a non-pharmaceutical treatment to improve the symptoms and severity of muscle cramps in patients with cirrhosis.
Eligible participants will be randomized to the treatment arm or control group. The treatment phase of the study will last 28 days. Information about participants will be collected including surveys and assessments throughout the study. Please note that only the participants randomized to experimental intervention group (Household Remedy) will be told what the treatment is during the study period. At the conclusion of the study (time of the final follow-up assessments), all participants will be debriefed on the use of concealment in this study as outlined in the protocol regarding the intervention.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of cirrhosis (criteria per protocol will be used)
- History of painful muscle spasms, cramps, or charley horses that come on while resting (they had to have happened 4 times in the past month and bother the participant)
Exclusion criteria
- Non-English speaking
- Unable or unwilling to provide consent
- History of liver transplant
- History of multiple sclerosis
- History of cerebral palsy
- History of stroke with paralysis
Trial design
Primary purpose
Allocation
Interventional model
Masking
82 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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