Trial Outcomes & Findings for A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome (NCT NCT02526277)
NCT ID: NCT02526277
Last Updated: 2021-01-28
Results Overview
Participants answer a series of 10 questions each of which have values ranging from 0 to 4, the points are then added together. Higher values are associated with more severe symptoms; up to a maximum severity score of 40 points and a minimum severity of 0 points.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
MMF07 Foot Massager Device
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
Heat Therapy
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device and Heat Therapy
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
Participants receiving no intervention will be asked to not alter their nighttime routine.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
8
|
6
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Baseline characteristics by cohort
| Measure |
MMF07 Foot Massager Device
n=8 Participants
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
Heat Therapy
n=6 Participants
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device and Heat Therapy
n=7 Participants
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
n=7 Participants
Participants receiving no intervention will be asked to not alter their nighttime routine.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.8 years
n=5 Participants
|
59.6 years
n=7 Participants
|
59.9 years
n=5 Participants
|
52.7 years
n=4 Participants
|
59.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Married
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
RLS Severity
Mild/moderate
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
RLS Severity
Severe/very severe
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksParticipants answer a series of 10 questions each of which have values ranging from 0 to 4, the points are then added together. Higher values are associated with more severe symptoms; up to a maximum severity score of 40 points and a minimum severity of 0 points.
Outcome measures
| Measure |
Heat Therapy
n=6 Participants
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device
n=8 Participants
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
MMF07 Foot Massager Device and Heat Therapy
n=7 Participants
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
n=7 Participants
Participants who received no intervention
|
|---|---|---|---|---|
|
The International Restless Legs Severity Scale
|
17.3 score on a scale
Standard Deviation 8.1
|
12.3 score on a scale
Standard Deviation 4.2
|
16.9 score on a scale
Standard Deviation 6.2
|
21.3 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 4 weeksParticipants answer a series of 18 questions that are scored such that lower scores indicate worse quality of life. The scoring process for the RLSQoL is relatively complicated. Items 1-5, 7-10, and 13 use scales ranging from 1 to 5, with lower scores indicating a greater frequency and interference of restless legs syndrome. The total score for these items is converted to a value between 0 and 100 using an algorithm provided along with the scale. Items 6 and 16-18 require respondents to indicate how many days in the previous month or hours in the previous day they have been able to complete certain activities or have had their daily functioning interfered with. These items are scored as continuous variables (for example, ranging from 0 to 28 days for questions regarding the number of days per month). Items 11, 12, 14, and 15 are categorical variables, where a response of "yes" receives (a 1), a response of "no" receives (a 2), and a response of "not applicable receives (3a).
Outcome measures
| Measure |
Heat Therapy
n=8 Participants
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device
n=6 Participants
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
MMF07 Foot Massager Device and Heat Therapy
n=7 Participants
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
n=7 Participants
Participants who received no intervention
|
|---|---|---|---|---|
|
The Restless Legs Quality of Life Questionnaire
|
82.4 score on a scale
Standard Deviation 20.9
|
66.7 score on a scale
Standard Deviation 25.6
|
74.2 score on a scale
Standard Deviation 19.1
|
57.1 score on a scale
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: 4 weeksParticipants answered a series of 12 questions assessing sleep, with values ranging from 1 to 6, and an additional dichotomous indicator of optimal sleep. All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is then converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. Reference: Spritzer, K. L. \& Hays, R. D. (2003, November). MOS Sleep Scale: A Manual for Use and Scoring, Version 1.0. Los Angeles, CA.
Outcome measures
| Measure |
Heat Therapy
n=8 Participants
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device
n=6 Participants
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
MMF07 Foot Massager Device and Heat Therapy
n=7 Participants
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
n=7 Participants
Participants who received no intervention
|
|---|---|---|---|---|
|
Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4
|
26.6 score on a scale
Standard Deviation 9.9
|
31.2 score on a scale
Standard Deviation 15.8
|
37.0 score on a scale
Standard Deviation 3.7
|
48.6 score on a scale
Standard Deviation 18.4
|
Adverse Events
MMF07 Foot Massager Device
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Heat Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMF07 Foot Massager Device and Heat Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MMF07 Foot Massager Device
n=8 participants at risk
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
MMF07 Foot Massager
|
Heat Therapy
n=6 participants at risk
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
Heat Therapy
|
MMF07 Foot Massager Device and Heat Therapy
n=7 participants at risk
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
MMF07 Foot Massager
Heat Therapy
|
No Treatment
n=7 participants at risk
Participants receiving no intervention will be asked to not alter their nighttime routine.
|
|---|---|---|---|---|
|
Nervous system disorders
Tingling
|
0.00%
0/8 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
14.3%
1/7 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Respiratory, thoracic and mediastinal disorders
influenza
|
0.00%
0/8 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
14.3%
1/7 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Nervous system disorders
migraine
|
0.00%
0/8 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
14.3%
1/7 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Skin and subcutaneous tissue disorders
itching
|
12.5%
1/8 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Nervous system disorders
sciatica
|
0.00%
0/8 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
14.3%
1/7 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Musculoskeletal and connective tissue disorders
jerking
|
12.5%
1/8 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Nervous system disorders
neuropathy
|
12.5%
1/8 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
|
Metabolism and nutrition disorders
low folic acid level
|
0.00%
0/8 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/6 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
14.3%
1/7 • Number of events 1 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
0.00%
0/7 • Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place