At a glance
ClinicalIndex Comparison Record- ✓Experience night-time leg cramps and spasms at least three times per week on average
- ✕Pregnancy
- ✕Previously diagnosed non-RLS sleep disorder
- ✕Schizophrenia or other neurological disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms Including Quality of Life, Depression and Sleep Quality
In Brief
A clinical study evaluating Theraworx and Placebo for Leg Cramp, Nocturnal. Completed, enrolled 57 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effect of Theraworx/\[pH\]uel on the frequency and severity of night-time cramps and spasms symptoms, including quality of life, depression and sleep quality when compared to a placebo.
Study Details
Timeline
Interventions
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.
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.