The Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms Including Quality of Life, Depression and Sleep Quality
Phase: NA
Conditions: Leg Cramp, Nocturnal
Sponsor: Sport and Spine Rehab Clinical Research Foundation

The Effect of Theraworx/[pH]uel on night-time cramps and spasm symptoms including quality 
of life, depression and sleep quality  
 
NCT03159260 
 
Date of Document: 2/1/2018 
 

Protocol 
Potential subjects were recruited through various targeted methods including newspaper ads, fliers in 
pharmacies and physician offices, social media, sleep disorder support groups and word of mouth.  
Individuals were excluded from the study if they were pregnant, have been previously diagnosed with a 
Restless Leg Syndrome (RLS), previously diagnosed with schizophrenia or any other neurological 
disorder. Individuals were included in the study if they reported experiencing night-time leg cramps on 
average at least three times per week. Eligible individuals were scheduled to attend an initial 
assessment (Baseline) at a community-based physical therapy clinic. During this visit the study was 
described by a member of the research team and the individual was asked to provide written consent to 
participate in the protocol (RB#: SSR.2016.3). Following providing informed consent, the subjects were 
asked to complete a series of questionnaires about their demographic characteristics, symptoms 
associated with NLC including sleep quality, quality of life and depression. Once these questionnaires 
were completed all subjects engaged in a 14-day no treatment period in which they were told not to 
change their usual activities and treatments.  Each morning during the 14 day no treatment period 
subjects were asked to complete a Symptom Log on which they documented the frequency and severity 
of night-time cramps they experienced the previous night.   
 
Subjects returned to clinic following this 14-day no treatment period (Post Control) and completed the 
same questionnaires excluding the demographic questions, since these demographic characteristics 
were not expected to change during the trial.  Variables that were collected at the Post Control data 
collection point included the same measures of sleep quality, quality of life and depression as were 
collected at Baseline.  Subjects were asked to refer their responses on these instruments to the previous 
2 weeks following completion of the Baseline assessment.  Once the subjects completed these 
instruments they were randomly assigned to one of two study groups by selecting 1 of 50 shuffled 
envelopes.  Within 25 of these envelopes a card indicated “Foam A” and the remaining 25 envelopes 
contained a card indicating “Foam B.”  Subjects received 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 remained blind to the subjects and the data collectors throughout the duration of 
the study until analysis.  One of the foams contained Theraworx Relief™ (treatment) and the other 
contained a physiologically inert substance (placebo).  Subjects were instructed to apply the foam they 
had 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 a subject 
experienced leg cramps after applying their assigned foam, they were instructed to reapply 2 pumps of 
the foam to the affected area in response to each event.  Each morning during the 14 days in which 
subjects applied the foam they were asked to complete the Compliance and Symptom Log that 
documented the frequency and severity of night-time cramps and their use of the assigned foam they 
used to treat their night-time cramps the previous evening.   Following 14 consecutive evenings of 
applying their assigned foam, subjects returned to the community clinic (Post Treatment), and return 
their completed Compliance and Symptom Log to the research staff.  During this final visit subjects again 
completed the same measures of sleep quality, quality of life and depression that they completed during 
their Baseline and Post Control visits, referring their responses to the previous 2 weeks when they were 
applying the assigned foam to their legs.  Subjects were compensated for completing the Baseline and 
Post Control and Post Treatment data collection visits.   
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis: 
Once all of the data were collected the contents of the foams were disclosed as Foam A containing the 
Placebo and Foam B containing the Treatment. The analysis was conducted in two phases. During phase 
1 descriptive statistics were calculated to describe the demographic characteristics of the sample in 
order to assess the external validity of the results and the application of the findings to the larger 
population of patients suffering with NLC. Further descriptive analysis determined if the outcome 
variables met the assumptions of parametric statistics. The second phase of the analysis involved 
addressing the study hypotheses. Repeated measures analysis of variance (R-ANOVA) were calculated to 
determine if any of the outcome variables significantly (p<.05) differed between or within the two study 
groups over the duration of the study. Main or interaction effects detected by the R-ANOVA were 
explored further through calculating Tukey’s post hoc comparisons. Finally, univariate comparisons (e.g. 
t-tests) determined if compliance rates or reported benefits differed between the study groups.  
 
Patients with night-time cramps and spasm 
14-day 
Foam B 
14-day     
Foam A 
T2 Data Collection 
T3 Data Collection 
Consent & Baseline Assessment (T1) 
14-day     
No 
Treatment