Trial Outcomes & Findings for Effect of Theraworx/[pH]Uel on Night-time Leg Cramps and Spasm Symptoms (NCT NCT03159260)
NCT ID: NCT03159260
Last Updated: 2019-03-25
Results Overview
Restless Legs Syndrome Quality of Life Instrument (RLSQoL) assesses the impact of restless legs symptoms on daily life, emotional well-being, social life and work life in adults 21 years and over. Each subsection is totaled separately and summed to form a total score from 0-100. Higher scores on the RLSQoL overall life impact score indicate a better quality of life. The subsections include Social Life, Daily Function, Sleep Quality, and Emotional Well-being. Each subsection questions are summed, divided by total score, and multiplied by 100 to form a scale of 0 (worst outcome) to 100 (best outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline, 2 weeks, and 4 weeks
Results posted on
2019-03-25
Participant Flow
Participant milestones
| Measure |
Theraworx
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
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|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Theraworx
n=28 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=29 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
n=28 Participants
|
52.1 years
n=29 Participants
|
49.8 years
n=57 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=28 Participants
|
16 Participants
n=29 Participants
|
39 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=28 Participants
|
13 Participants
n=29 Participants
|
18 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, and 4 weeksPopulation: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section.
Restless Legs Syndrome Quality of Life Instrument (RLSQoL) assesses the impact of restless legs symptoms on daily life, emotional well-being, social life and work life in adults 21 years and over. Each subsection is totaled separately and summed to form a total score from 0-100. Higher scores on the RLSQoL overall life impact score indicate a better quality of life. The subsections include Social Life, Daily Function, Sleep Quality, and Emotional Well-being. Each subsection questions are summed, divided by total score, and multiplied by 100 to form a scale of 0 (worst outcome) to 100 (best outcome).
Outcome measures
| Measure |
Theraworx
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
|---|---|---|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Daily Week 4
|
81.50 units on a scale
Standard Error 3.64
|
85.50 units on a scale
Standard Error 3.64
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Sleep Baseline
|
29.56 units on a scale
Standard Error 4.16
|
37.11 units on a scale
Standard Error 4.16
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Sleep Week 2
|
35.33 units on a scale
Standard Error 3.91
|
42.04 units on a scale
Standard Error 3.91
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Sleep Week 4
|
47.55 units on a scale
Standard Error 4.59
|
53.89 units on a scale
Standard Error 4.59
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Emotional Baseline
|
58 units on a scale
Standard Error 5.98
|
67 units on a scale
Standard Error 5.98
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Emotional Week 2
|
64.33 units on a scale
Standard Error 5.51
|
72.33 units on a scale
Standard Error 5.51
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Emotional Week 4
|
77 units on a scale
Standard Error 4.5
|
82.37 units on a scale
Standard Error 4.5
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_QoL Week 2
|
61.30 units on a scale
Standard Error 3.9
|
68.29 units on a scale
Standard Error 3.9
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Social Baseline
|
78.92 units on a scale
Standard Error 4.36
|
80.75 units on a scale
Standard Error 4.36
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Social Week 2
|
77.75 units on a scale
Standard Error 3.92
|
83.16 units on a scale
Standard Error 3.92
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Social Week 4
|
87 units on a scale
Standard Error 3.47
|
87.03 units on a scale
Standard Error 3.47
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Daily Baseline
|
65.33 units on a scale
Standard Error 4.97
|
73.17 units on a scale
Standard Error 4.97
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_Daily Week 2
|
69.50 units on a scale
Standard Error 4.39
|
77.49 units on a scale
Standard Error 4.39
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_QoL Baseline
|
58.02 units on a scale
Standard Error 4.28
|
64.51 units on a scale
Standard Error 4.28
|
|
Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks
RLS_QoL Week 4
|
72.82 units on a scale
Standard Error 3.61
|
76.29 units on a scale
Standard Error 3.61
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, and 4 weeksPopulation: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
The Beck Depression Scale is one of the most widely used psychometric tests for measuring the severity of depression. The score is calculated by adding up the score for each of the twenty-one questions by counting the number to the right of each question marked. The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero. The level of depression is evaluated by: 0-10 (These ups and downs are considered normal);11-16 (Mild mood disturbance); 17-20 (Borderline clinical depression); 21-30 (Moderate depression); 31-40 (Severe depression); over 40 (Extreme depression).
Outcome measures
| Measure |
Theraworx
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
|---|---|---|
|
Change in Beck Depression Scale Over 4 Weeks
2 Weeks
|
9.56 units on a scale
Standard Error 1.6
|
6.92 units on a scale
Standard Error 1.6
|
|
Change in Beck Depression Scale Over 4 Weeks
4 Weeks
|
6.88 units on a scale
Standard Error 1.3
|
5.6 units on a scale
Standard Error 1.3
|
|
Change in Beck Depression Scale Over 4 Weeks
Baseline
|
12.4 units on a scale
Standard Error 1.75
|
8.48 units on a scale
Standard Error 1.75
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, and 4 weeksPopulation: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
The Pittsburgh Sleep Quality Index is used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The seven component scores are added together for a global score ranging from 0 to 21, 0 indicating no difficulty and 21 indicating severe difficulties.
Outcome measures
| Measure |
Theraworx
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index Over 4 Weeks
Pittsburgh Sleep Quality Baseline
|
10.72 units on a scale
Standard Error 0.84
|
10.12 units on a scale
Standard Error 0.84
|
|
Change in Pittsburgh Sleep Quality Index Over 4 Weeks
Pittsburgh Sleep Quality Week 2
|
11 units on a scale
Standard Error 0.83
|
9.52 units on a scale
Standard Error 0.83
|
|
Change in Pittsburgh Sleep Quality Index Over 4 Weeks
Pittsburgh Sleep Quality Week 4
|
9.12 units on a scale
Standard Error 0.85
|
7.8 units on a scale
Standard Error 0.85
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, and 4 weeksPopulation: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
The Modified Patient Specific Functional Scale is used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition. Three important activities that are unable to be done or are having difficulty are rated from 0 to 10, 0 being unable to perform and 10 being able to perform activity at the same level as before injury or problem. The total score is the sum of the activity scores divided by the number of activities, ranging from 0 (worst outcome) to 10 (best outcome).
Outcome measures
| Measure |
Theraworx
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
|---|---|---|
|
Change in Modified Patient Specific Functional Scale Over 4 Weeks
Baseline
|
4.53 units on a scale
Standard Error 0.58
|
5.76 units on a scale
Standard Error 0.58
|
|
Change in Modified Patient Specific Functional Scale Over 4 Weeks
2 Weeks
|
4.99 units on a scale
Standard Error 0.55
|
6.59 units on a scale
Standard Error 0.55
|
|
Change in Modified Patient Specific Functional Scale Over 4 Weeks
4 Weeks
|
6.47 units on a scale
Standard Error 0.58
|
7.4 units on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4Population: Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section
Patients will track the number of times their leg cramps/spasms for the first 2 weeks without intervention and then how many times during the two weeks using the intervention.
Outcome measures
| Measure |
Theraworx
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
Placebo
n=25 Participants
Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control).
Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting 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.
|
|---|---|---|
|
Change in Symptom Log Over 4 Weeks
Week 1
|
5.12 Leg Cramps and Spasm
Standard Error 0.34
|
4.72 Leg Cramps and Spasm
Standard Error 0.34
|
|
Change in Symptom Log Over 4 Weeks
Week 2
|
4.72 Leg Cramps and Spasm
Standard Error 0.42
|
4.8 Leg Cramps and Spasm
Standard Error 0.42
|
|
Change in Symptom Log Over 4 Weeks
Week 3
|
4.44 Leg Cramps and Spasm
Standard Error 0.45
|
3.32 Leg Cramps and Spasm
Standard Error 0.45
|
|
Change in Symptom Log Over 4 Weeks
Week 4
|
3.92 Leg Cramps and Spasm
Standard Error 0.59
|
3.92 Leg Cramps and Spasm
Standard Error 0.59
|
Adverse Events
Theraworx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jena Slaski
Sport and Spine Rehab Clinical Research Foundation
Phone: 301-251-2777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place