Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Back Pain, Acute Sleep Disorder Sleep Disorders, Circadian Rhythm Sleep Sleep Deprivation Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blind, placebo controlled, crossover trial with functional measurements

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active/Treatment

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Non-Active/Control

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.

Group Type SHAM_COMPARATOR

Sham Patch without haptic vibrotactile trigger technology (VTT)

Intervention Type DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Crossover

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Sham Patch without haptic vibrotactile trigger technology (VTT)

Intervention Type DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Interventions

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Drug- 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)

Intervention Type DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Intervention Type DEVICE

Other Intervention Names

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Haptic Vibrotactile Trigger Technology VTT Sham Comparator

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No