Topical Patches for Pain and Sleep Disorders
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if drug-free patches can aid in pain relief and improve sleep. Participants will receive either an active patch (FREEDOM or REM Patch) or a placebo (inactive) patch to compare effects. The study will assess how the patches affect pain and sleep over a short period. It suits individuals with acute, moderate pain, such as back or shoulder pain, who are willing to wear a patch during the trial. As an unphased trial, it offers participants the opportunity to explore innovative, medication-free pain relief methods.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this patch is safe for pain and sleep disorders?
Research has shown that drug-free, non-invasive patches like the FREEDOM or REM Patch are generally safe. One study found that similar patches did not cause any negative effects, suggesting they might be a good option for managing muscle and joint pain. However, a report noted a skin reaction, such as redness and itching, lasting two weeks after using a patch. Those with sensitive skin should consider this. While most people do not experience problems, there is a small chance of skin irritation.12345
Why are researchers excited about this trial?
Researchers are excited about these treatments because the FREEDOM and REM patches offer a drug-free, non-invasive way to address pain and sleep disorders. Unlike standard treatments that often involve medications like opioids for pain or sedatives for sleep issues, these patches provide a new delivery method that avoids potential side effects and dependency. The patches are applied topically, which is convenient and easy for users. Additionally, with the potential for quicker results — in just a few days — these patches could provide faster relief compared to traditional medications that might take longer to show effects.
What evidence suggests that this patch is effective for pain and sleep disorders?
This trial will evaluate the effectiveness of drug-free, non-invasive patches, specifically the FREEDOM or REM Patch, for pain relief and sleep improvement. Research has shown that similar patches may aid in pain relief and enhance sleep. Studies have found that people using similar patches experience less pain and find daily activities easier. Another study found that these patches can improve sleep quality and duration, leading to a better mood and reduced daytime tiredness. The patches use a special technology that gently stimulates the skin to help the body function better without drugs. This suggests that these patches could effectively manage pain and sleep problems.14678
Who Is on the Research Team?
Janet Fason, DO
Principal Investigator
Stein Medical Center
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Data collected at Baseline prior to first use of active or sham patch
Treatment
Participants receive either the active patch (FREEDOM or REM) or sham patch, with data collection at 7 and 14 days
Crossover
Control group subjects crossover to receive the active patch after completion of the control group study period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
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.
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.
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
Who Is Running the Clinical Trial?
SuperPatch Limited LLC
Lead Sponsor
Clarity Science LLC
Collaborator
Citations
Relieving Pain and Improving Sleep: Evaluating Topical ...
This IRB-approved, Randomized Controlled Trial (RCT) will measure effectiveness of the pain and sleep patches through assessment of validated scales and ...
Decreased anxiety through haptic technology patch usage
[44] This study evaluated an over-the-counter, noninvasive, drug-free patch (PEACE Patch; Super Patch Company, Srysty Holding Co, Toronto, ...
Reducing Pain and Improving Mobility Using Haptic Patch ...
The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active ...
Improving Sleep and Quality of Life after Use of a Haptic ...
This non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch improves sleep quality, duration, and quality-of-life ...
Improving Sleep and Quality of Life after Use of a ... - Abstract
Results also showed positive outcomes in Quality of Life (QoL) components with improvements in daytime fatigue, mood, ability to function at work/daily chores, ...
6.
scivisionpub.com
scivisionpub.com/pdfs/a-pilot-study-of-the-signal-relieftm-patch-for-the-treatment-of-musculoskeletal-pain-2872.pdfA Pilot Study of the Signal Relief™ Patch for the Treatment of ...
No adverse events were reported. Our findings suggest that the Signal Relief™ may be an effective non-invasive, drug-free option for the ...
NCT05288114 | Signal Relief Patch in Musculoskeletal Pain
The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries.
8.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20532950&pc=HXTMAUDE Adverse Event Report: THE SUPER PATCH ...
She is not overly sensitive, however after using the patch she experienced a severe skin reaction including redness and itching which persisted over 2 weeks ...
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