Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches (RESTORE)

SuperPatch Limited LLC

Status

Invitation-only

Conditions

Pain, Back

Sleep Disorder

Insomnia

Pain, Acute

Sleep Disorders, Circadian Rhythm

Sleep Deprivation

Sleep

Treatments

Device: Sham Patch without haptic vibrotactile trigger technology (VTT)

Device: Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06505005

RESTORE-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

150 participants in 3 patient groups

Active/Treatment

Active Comparator group

Description:

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.

Treatment:

Device: Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:

Non-Active/Control

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Patch without haptic vibrotactile trigger technology (VTT)

Crossover

Active Comparator group

Description:

Treatment:

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)