Pain, BackRESTORENCT06505005

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

A study testing Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names: in people with Pain, Back and Pain, Acute, run by SuperPatch Limited LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain, Back, Pain, Acute, Sleep Disorder
What is being tested?: Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2024to 1 Aug 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Stein Medical
Tyrone, Georgia, 30290

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Pain, Back, Pain, Acute, Sleep Disorder, Sleep Disorders, Circadian Rhythm, Sleep, Sleep Deprivation
Being 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)
Keywords: musculoskeletal pain, sleep disorder, insomnia, back pain, acute pain, sleep
Medical subject headings: Back Pain, Acute Pain, Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:Device
Also called Haptic Vibrotactile Trigger Technology, VTT
Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)
Sham Patch without haptic vibrotactile trigger technology (VTT)Device
Also called Sham Comparator
Sham Patch without haptic vibrotactile trigger technology (VTT)

Study groups in NCT06505005
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days

Secondary outcomes (3)

Changes in Pain Medication Use
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.
Measured: 14 days
Changes in Sleep Medication Use
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.
Measured: 14 days
Changes in Awakenings during sleep
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.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20241 Aug 2026

First posted17 Jul 2024
Study start20 Sep 2024
Primary completion1 Aug 2026
Study completion1 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, BackStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized, double-blind, placebo controlled, crossover trial with functional measurements
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06505005
Sponsor's protocol ID: RESTORE-001
Acronym: RESTORE
Status last verified: Aug 2026
First submitted: 10 Jul 2024
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 41057672

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RESTORE (Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches to Optimize Effectiveness)
ClinicalTrials.gov ID: NCT06505005
Acronym / sponsor ID: RESTORE / RESTORE-001
Conditions: Pain, Back, Pain, Acute, Sleep Disorder, Sleep Disorders, Circadian Rhythm, Sleep, Sleep Deprivation
Keywords: musculoskeletal pain, sleep disorder, insomnia, back pain, acute pain, sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: SuperPatch Limited LLCIndustry (pharma, biotech, devices)
Collaborators: Clarity Science LLC
Study start: 20 Sep 2024 (actual)
Primary completion: 1 Aug 2026 (actual)
Study completion: 1 Aug 2026 (actual)
First posted: 17 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3
Model description: Randomized, double-blind, placebo controlled, crossover trial with functional measurements

Arm	Type	Receives
Active/Treatment	Active comparator	Device: Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names: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.
Non-Active/Control	Sham comparator	Device: Sham Patch without haptic vibrotactile trigger technology (VTT)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.
Crossover	Active comparator	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)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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:Also: Haptic Vibrotactile Trigger Technology, VTTDrug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT)	Device	Active/Treatment, Crossover
Sham Patch without haptic vibrotactile trigger technology (VTT)Also: Sham ComparatorSham Patch without haptic vibrotactile trigger technology (VTT)	Device	Crossover, Non-Active/Control

Primary outcome

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.
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.
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).
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).
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).
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.
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.
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.
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.

3 secondary outcomes

Changes in Pain Medication Use
Time frame: 14 days
Changes in Sleep Medication Use
Time frame: 14 days
Changes in Awakenings during sleep
Time frame: 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Derived from this study: PubMed 41057672Fason 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.

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Fason, DO principal investigator

Stein Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain Severity (time frame: 14 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06505005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.