Your session is about to expire
← Back to Search
Other
Topical Patches for Pain and Sleep Disorders (RESTORE Trial)
N/A
Waitlist Available
Led By Janet Fason, DO
Research Sponsored by SuperPatch Limited LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Ages 18-64
* Received a study patch (active or sham) from their treating clinician (randomized) for back, shoulder, and other musculoskeletal pain.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Summary
This trial will test a drug-free patch called FREEDOM or REM Patch to see if it helps with pain relief and sleep improvement. The study is approved by an ethics committee and will use validated scales
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the patches are drug-free and non-invasive, side effects may be minimal but could include skin irritation at the site of application or discomfort from wearing the patch.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Select...
I received a study patch for pain from my doctor.
Select...
I have been diagnosed with moderate, short-term pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Pain Interference
Changes in Pain Severity
Changes in Range of Motion and Flexibility
+3 moreSecondary study objectives
Changes in Awakenings during sleep
Changes in Pain Medication Use
Changes in Sleep Medication Use
Other study objectives
Any side effects reported by patients will be documented and assessed by clinician and PI
Trial Design
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 Location
Who is running the clinical trial?
SuperPatch Limited LLCLead Sponsor
2 Previous Clinical Trials
250 Total Patients Enrolled
Clarity Science LLCUNKNOWN
2 Previous Clinical Trials
250 Total Patients Enrolled
Janet Fason, DOPrincipal InvestigatorStein Medical Center