Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches
NCT Number: NCT06505005
Acronym: RESTORE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Back|Pain, Acute|Sleep Disorder|Sleep Disorders, Circadian Rhythm|Sleep|Sleep Deprivation|Insomnia
Interventions: DEVICE: Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:|DEVICE: Sham Patch without haptic vibrotactile trigger technology (VTT)
Sponsor: SuperPatch Limited LLC
Collaborators: Clarity Science LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-02-01

Summary:
This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational 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.

Primary Outcome Measures: 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, 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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