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

NACompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

November 1, 2016

Primary Completion Date

June 1, 2017

Study Completion Date

December 30, 2017

Conditions
Leg Cramp, Nocturnal
Interventions
DEVICE

Theraworx

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.

OTHER

Placebo

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.

Trial Locations (1)

20852

Sport and Spine Rehab, Rockville

All Listed Sponsors
lead

Sport and Spine Rehab Clinical Research Foundation

OTHER

NCT03159260 - Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms | Biotech Hunter | Biotech Hunter