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| Name | Class |
|---|---|
| Clarity Science LLC | UNKNOWN |
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This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.
Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The FREEDOM and REM patch (SuperPatch Company, Toronto, Canada and Florida, USA) that also incorporates this technology has shown promise to improve relieve pain and improve sleep. This IRB-approved, Randomized Controlled Trial (RCT) will measure effectiveness of the pain and sleep patches through assessment of validated scales and functional measurements such as the Brief Pain Inventory (BPI), the Schober Test, the Bubble Inclinometer Measurement, and the Flexion Finger-Floor Measurement for the pain patch, and Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), and a sleep wearable monitor for the Sleep patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active/Treatment | Active Comparator | Data will be collected at Baseline prior to first use of active patch (FREEDOM or REM) and then 7 days, and then at 14 days after use with the active patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline. |
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| Non-Active/Control | Sham Comparator | Data will be collected at Baseline prior to first use of sham patch and then 7 days, and then at 14 days after use with the sham patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline. Control group subjects will be crossed over to crossover group after completion of control group study period. |
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| Crossover | Active Comparator | Data will be collected at Baseline prior to first use of active patch (FREEDOM or REM) and then 7 days, and then at 14 days after use with the active patch. Baseline and Follow-up functional measurements will also be taken at 7 and 14 days after baseline for all arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names: | Device | Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Severity | Changes in Pain Severity Score based on Brief Pain Inventory (BPI) for those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch. (PAIN SEVERITY SCORE: 0-10 Scale). Decrease in Severity Score indicates a decrease in pain severity. | 14 days |
| Changes in Pain Interference | Changes in Pain Interference Score based on Brief Pain Inventory (BPI) or those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch. (PAIN INTERFERENCE SCORE: 0-10 Scale). Decrease in Interference Score indicates a decrease in pain interference. | 14 days |
| Changes in Range of Motion and Flexibility | Changes in Range of Motion and Flexibility based on subject and clinician reporting for those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch. Subjects will be evaluated with a Schober test measurement (cm). | 14 days |
| Changes in Range of Motion and Flexibility | Changes in Range of Motion and Flexibility based on subject and clinician reporting for those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch. Subjects will be evaluated with a Goniometer measurement (degree of rotation/360 and cm). | 14 days |
| Changes in Range of Motion and Flexibility | Changes in Range of Motion and Flexibility based on subject and clinician reporting for those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch. Subjects will be evaluated with a Bubble Inclinometer measurement (degree of rotation/360). | 14 days |
| Changes in Sleep Duration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Medication Use | Changes in Number of Pain Medications Used based on subject and clinician reporting for those subjects in Pain Arm and receiving the active patch (FREEDOM) or Control Sham patch during study period. | 14 days |
| Changes in Sleep Medication Use |
| Measure | Description | Time Frame |
|---|---|---|
| Any side effects reported by patients will be documented and assessed by clinician and PI | Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator. | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Fason, DO | Stein Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stein Medical | Tyrone | Georgia | 30290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057672 | Derived | Fason J, Hurwitz P, Gudin J. Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study. Pain Ther. 2025 Dec;14(6):1797-1807. doi: 10.1007/s40122-025-00780-0. Epub 2025 Oct 8. |
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Randomized, double-blind, placebo controlled, crossover trial with functional measurements
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| Sham Patch without haptic vibrotactile trigger technology (VTT) | Device | Sham Patch without haptic vibrotactile trigger technology (VTT) |
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Changes in Sleep Duration based on Pittsburgh Quality Sleep Index (PSQI) for those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch. |
| 14 days |
| Changes in Sleep Duration | Changes in Sleep Duration based on a measurement from a wearable device) for those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch. | 14 days |
| Changes in Sleep Quality | Changes in Sleep Quality based on Pittsburgh Quality Sleep Index (PSQI) for those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch. | 14 days |
| Changes in Sleep Interference | Changes in Sleep Interference Score based on Insomnia Severity Index (ISI) or those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch. | 14 days |
Changes in Number of Sleep Medication Used based on subject and clinician reporting for those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch during the study period. |
| 14 days |
| Changes in Awakenings during sleep | Changes in awakenings Use based on subject and clinician reporting for those subjects in Sleep Arm and receiving the active patch (REM) or Control Sham patch. | 14 days |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D059787 | Acute Pain |
| D012893 | Sleep Wake Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| D012892 | Sleep Deprivation |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D021081 | Chronobiology Disorders |
| D020920 | Dyssomnias |
| D009784 | Occupational Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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