Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms

50 subjects who claim to have experienced night-time cramps and spasms on average at least
three times per week will be recruited. Eligible individuals will be scheduled to attend a
"consent and baseline assessment" (T1). During this visit, the study will be described by a
member of the research team and the subjects will be asked to provide written consent to
participate in the protocol. Following providing informed consent, the subjects will be asked
to complete a series of questionnaires about their demographic characteristics, presence and
severity of night-time cramps and spasms symptoms, including quality of life, depression and
sleep quality. Once these questionnaires are completed all subjects will complete a 14-day no
treatment period in which they will be told to engage in their usual activities and
treatments. Subjects will return following this two week period (T2) and complete the same
questionnaires. Variables that will be collected at T2 include presence and severity of
night-time cramps and spasm symptoms, including quality of life, depression and sleep
quality. Subjects will be asked to refer their responses on these instruments to the previous
2 weeks following completion of the baseline assessment. Once the subjects have completed
these instruments they will be randomly assigned to one of two study groups with 25 of in
"Foam A" and 25 in"Foam B." 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.
Subjects will be instructed to apply the topical foam they have been assigned to their entire
upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh
to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps
or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the
affected area in response to each event. Each morning during the 14 days in which subjects
apply the foam they will be asked to complete the Compliance and Symptom Log that documents
the incidence and severity of night-time cramps and spasms their use of the foam and any
other therapies they used to treat their night-time cramps and spasm. Following 14
consecutive days of applying the assigned foam, subjects will return to SSR (T3) and return
the completed Treatment Compliance Log to the research staff. During this final visit
subjects will again complete the same questionnaires that were completed during the T2 visit,
referring the responses to the previous 2 weeks when the subjects were applying the assigned
foam to the legs.

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