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Enrolling by Invitation

NCT Number: NCT06505005

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

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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Key information

Conditions

Pain, Back Acute Pain Back Pain Chronobiology Disorders Dyssomnias Insomnia Mental Disorders Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Occupational Diseases Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Sleep Deprivation Sleep Disorder Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stein Medical

Tyrone, Georgia, 30290, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Other names: Haptic Vibrotactile Trigger Technology, VTT

Sham Patch without haptic vibrotactile trigger technology (VTT)

Device

Sham Patch without haptic vibrotactile trigger technology (VTT)

Other names: Sham Comparator

Primary outcomes

  1. Changes in Pain Severity

    Time frame: 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.

  2. Changes in Pain Interference

    Time frame: 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.

  3. Changes in Range of Motion and Flexibility

    Time frame: 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).

  4. Changes in Range of Motion and Flexibility

    Time frame: 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 Goniometer measurement (degree of rotation/360 and cm).

  5. Changes in Range of Motion and Flexibility

    Time frame: 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 Bubble Inclinometer measurement (degree of rotation/360).

  6. Changes in Sleep Duration

    Time frame: 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.

  7. Changes in Sleep Duration

    Time frame: 14 days

    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.

  8. Changes in Sleep Quality

    Time frame: 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.

  9. Changes in Sleep Interference

    Time frame: 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 outcomes

  1. Changes in Pain Medication Use

    Time frame: 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.

  2. Changes in Sleep Medication Use

    Time frame: 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.

  3. Changes in Awakenings during sleep

    Time frame: 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.

Other outcomes

  1. Any side effects reported by patients will be documented and assessed by clinician and PI

    Time frame: 14 days

    Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator.

Sponsors and collaborators

Lead sponsor

SuperPatch Limited LLC

Industry

Collaborators

  • Clarity Science LLC

Registry information

Official study title

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

Acronym: RESTORE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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