Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms
Leg Cramp, Nocturnal
About this trial
This is an interventional treatment trial for Leg Cramp, Nocturnal focused on measuring night-time leg cramps, topical, spasm
Eligibility Criteria
Inclusion Criteria:
- Subjects who claim to have experienced night-time cramps and spasms on average at least three times per week
Exclusion Criteria:
- Individuals will be excluded from the study if they are pregnant, have been previously diagnosed with a non-RLS sleep disorder, previously diagnosed with schizophrenia or any other neurological disorder
Sites / Locations
- Sport and Spine Rehab
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Theraworx
Placebo
Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control).
Subjects will receive two 3 ounce foam dispensers corresponding to their group assignment (Foam A or Foam B) and a 2-week Compliance and Symptom Log. The contents of these two foams will remain blind to the subjects and the data collectors until all 50 subjects complete the study protocol. One of the foams will contain Theraworx/[pH]uel (treatment) and the other will contain a physiologically inert substance (placebo control).