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NCT06505005

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

Enrolling by Invitation
NAAges 18–65InterventionalTreatment
SuperPatch Limited LLC
~150 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:Sham Patch without haptic vibrotactile trigger technology (VTT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Pain Severity
Measured over 14 days
+8 more outcomes measured

Conditions

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

Explore related trials

Acute PainBack PainMusculoskeletal PainShoulder Pain

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Janet Fason, DO · PRINCIPAL_INVESTIGATOR · Stein Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Changes in Pain Severity14 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 Interference14 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 Flexibility14 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 Range of Motion and Flexibility14 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).

  • Changes in Range of Motion and Flexibility14 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).

  • Changes in Sleep Duration14 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 Duration14 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.

  • Changes in Sleep Quality14 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 Interference14 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.