Topical Patches for Pain and Sleep Disorders

(RESTORE Trial)

Overseen By Peter Hurwitz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SuperPatch Limited LLC

Must not be taking: Drugs of abuse

Disqualifiers: Government healthcare, Implanted device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Janet Fason, DO

Principal Investigator

Stein Medical Center

Eligibility Criteria

This trial is for adults aged 18-64 with moderate musculoskeletal pain, such as back or shoulder pain. Participants must be able to consent and agree to wear an adhesive study patch. It's not specified who can't join, but typically those with certain health conditions or sensitivities might be excluded.

Inclusion Criteria

* Ability to provide Informed Consent

* Agrees to wear an adhesive study patch during the study period

I received a study patch for pain from my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Data collected at Baseline prior to first use of active or sham patch

1 day

1 visit (in-person)

Treatment

Participants receive either the active patch (FREEDOM or REM) or sham patch, with data collection at 7 and 14 days

2 weeks

2 visits (in-person)

Crossover

Control group subjects crossover to receive the active patch after completion of the control group study period

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Drug-free, non-invasive patch (FREEDOM or REM Patch)

Trial Overview The study tests a drug-free, non-invasive patch using haptic vibrotactile trigger technology (VTT) against a sham patch without VTT. The goal is to see if the active patch can relieve pain and improve sleep in participants compared to the placebo.

Participant Groups

Group I: Active/Treatment Active Control 1 Intervention

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 II: Crossover Active Control 2 Interventions

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 III: Non-Active/Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

SuperPatch Limited LLC

Lead Sponsor

Trials

3

Recruited

400+

Clarity Science LLC

Collaborator

Trials

3

Recruited

400+