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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)
Sham Patch without haptic vibrotactile trigger technology (VTT)
Stein Medical
Tyrone, Georgia, United States
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 14 days
Changes in Sleep Duration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
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.
Time frame: 14 days
Changes in Sleep Medication Use
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.
Time frame: 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.
Time frame: 14 days
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