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| Name | Class |
|---|---|
| MedMassager | UNKNOWN |
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The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS. Participants will be randomly assigned to one of four treatment groups;
Few clinical trials have looked into non-pharmacological, non-invasive treatments for restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy is associated with improved severity of RLS symptoms.
For this study the investigator will enroll 40 participants who have been diagnosed with restless legs syndrome, who will be followed over the course of four weeks and asked to complete two in person study visits. In the study the investigator is comparing the use of the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if the symptoms of RLS improve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF07 Foot Massager device | Active Comparator | 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. |
|
| Heat therapy | Active Comparator | 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. |
|
| MMF07 Foot Massager device and heat therapy | Active Comparator | 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. |
|
| No treatment | No Intervention | Participants receiving no intervention will be asked to not alter their nighttime routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMF07 Foot Massager | Device |
| ||
| Heat Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The International Restless Legs Severity Scale | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Restless Legs Quality of Life Questionnaire | Participants 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariane Park, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43221 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | No Treatment | Participants receiving no intervention will be asked to not alter their nighttime routine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The International Restless Legs Severity Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
Participants were seen at a Baseline visit and then followed up approximately 4 weeks later for a maximum of 31 days participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Nervous system disorders | MeSH | Non-systematic Assessment | Tingling in bilateral feet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariane Park, MD | The Ohio State University | 614.293.4969 | Ariane.Park@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2015 | Dec 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Device |
|
| 4 weeks |
| Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 | Participants 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. | 4 weeks |
| 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 |
| BG002 | 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 |
| BG003 | No Treatment | Participants receiving no intervention will be asked to not alter their nighttime routine. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Married | Number of participants who classified themselves as being married while enrolled in the study. | Count of Participants | Participants |
|
| RLS Severity | The severity of restless legs syndrome discomfort is measured by using the International Restless Legs Severity Scale. It is a 40 point scale measuring severity of restless leg symptoms. Patients are asked to answer a series of 10 questions each of which have values ranging from 0 to 4 and the points are then added. Higher values are associated with more severe symptoms. | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | No Treatment | Participants who received no intervention |
|
|
| Secondary | The Restless Legs Quality of Life Questionnaire | Participants 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). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 | Participants 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 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 | 0 | 7 | 0 | 7 | 4 | 7 |
| EG003 | No Treatment | Participants receiving no intervention will be asked to not alter their nighttime routine. | 0 | 7 | 0 | 7 | 1 | 7 |
|
| influenza | Respiratory, thoracic and mediastinal disorders | MeSH | Non-systematic Assessment |
|
| migraine | Nervous system disorders | MeSH | Non-systematic Assessment | migraine headache |
|
| itching | Skin and subcutaneous tissue disorders | MeSH | Non-systematic Assessment | intermittent itching of bilateral feet and ankles |
|
| sciatica | Nervous system disorders | MeSH | Non-systematic Assessment |
|
| jerking | Musculoskeletal and connective tissue disorders | MeSH | Non-systematic Assessment | right leg jerking |
|
| itching | Skin and subcutaneous tissue disorders | MeSH | Non-systematic Assessment | bilateral itching on bottom of each foot |
|
| neuropathy | Nervous system disorders | MeSH | Non-systematic Assessment | worsening of neuropathy |
|
| low folic acid level | Metabolism and nutrition disorders | MeSH | Non-systematic Assessment |
|
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |