Insomnia, Pain, Acute, Pain, Back, Sleep, Sleep Deprivation, Sleep Disorder, Sleep Disorders, Circadian Rhythm
Conditions
Keywords
musculoskeletal pain, sleep disorder, insomnia, back pain, acute pain, sleep
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDrug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:
Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)
DEVICESham Patch without haptic vibrotactile trigger technology (VTT)
Sham Patch without haptic vibrotactile trigger technology (VTT)
Sponsors
SuperPatch Limited LLC
Clarity Science LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo controlled, crossover trial with functional measurements
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-64 * Ability to provide Informed Consent * Received a study patch (active or sham) from their treating clinician (randomized) for back, shoulder, and other musculoskeletal pain. * Has been diagnosed with an acute, moderate pain condition * Agrees to wear an adhesive study patch during the study period
Exclusion criteria
* Patients who are beneficiaries of a government-funded healthcare program * Use of drugs of abuse (illicit or prescription) * Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Severity | 14 days | 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. |
| Changes in Pain Interference | 14 days | 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. |
| Changes in Range of Motion and Flexibility | 14 days | 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). |
| Changes in Sleep Duration | 14 days | 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. |
| Changes in Sleep Quality | 14 days | 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. |
| Changes in Sleep Interference | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Medication Use | 14 days | 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. |
| Changes in Sleep Medication Use | 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. |
| Changes in Awakenings during sleep | 14 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJanet Fason, DO
Stein Medical Center
Outcome results
None listed