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

NCT06505005 | Enrolling By Invitation

• 1 other identifier: RESTORE-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

musculoskeletal pain; sleep disorder; insomnia; back pain; acute pain; sleep

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Changes in Pain Medication Use

  14 days

• Changes in Sleep Medication Use

  14 days

• Changes in Awakenings during sleep

  14 days

Other Outcomes (1)

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

  14 days

Study Arms (3)

Active/Treatment

ACTIVE COMPARATOR

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.

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

Non-Active/Control

SHAM COMPARATOR

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.

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

Crossover

ACTIVE COMPARATOR

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.

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)

Interventions

Sham Patch without haptic vibrotactile trigger technology (VTT) DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Also known as: Sham Comparator

Crossover; Non-Active/Control

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)

Also known as: Haptic Vibrotactile Trigger Technology, VTT

Active/Treatment; Crossover

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• Clarity Science LLC: collaborator

Study Sites (1)

Stein Medical

Tyrone, Georgia, 30290, United States

Location

Related Publications (1)

• Fason J, Hurwitz P, Gudin J. Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study. Pain Ther. 2025 Dec;14(6):1797-1807. doi: 10.1007/s40122-025-00780-0. Epub 2025 Oct 8.

  PMID: 41057672 DERIVED

MeSH Terms

Conditions

Back Pain; Acute Pain; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Dyssomnias; Occupational Diseases; Sleep Disorders, Intrinsic; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Janet Fason, DO

  Stein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: September 20, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

US (1)