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.
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
I am between 18 and 64 years old.
I received a study patch for pain from my doctor.
I have been diagnosed with moderate, short-term pain.
Treatment Details
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.
3Treatment groups
Active Control
Placebo Group
Group I: Active/TreatmentActive Control1 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: CrossoverActive Control2 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/ControlPlacebo Group1 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stein MedicalTyrone, GA
Loading ...
Who is running the clinical trial?
SuperPatch Limited LLCLead Sponsor
Clarity Science LLCCollaborator