Clinical trial NCT06505005: Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches
Official title: RESTORE (Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches to Optimize Effectiveness)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain, Back
Pain, Acute
Sleep Disorder
Sleep Disorders, Circadian Rhythm
Sleep
Sleep Deprivation
Insomnia
Keywords: musculoskeletal pain
sleep disorder
insomnia
back pain
acute pain
sleep
Lead sponsor: SuperPatch Limited LLC
Sponsor class: INDUSTRY
Collaborators: name: Clarity Science LLC
First posted: 2024-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo controlled, crossover trial with functional measurements
Primary purpose: TREATMENT

Brief 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 functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Pain Severity
timeFrame: 14 days
measure: Changes in Pain Interference
timeFrame: 14 days
measure: Changes in Range of Motion and Flexibility
timeFrame: 14 days
measure: Changes in Range of Motion and Flexibility
timeFrame: 14 days
measure: Changes in Range of Motion and Flexibility
timeFrame: 14 days
measure: Changes in Sleep Duration
timeFrame: 14 days
measure: Changes in Sleep Duration
timeFrame: 14 days
measure: Changes in Sleep Quality
timeFrame: 14 days
measure: Changes in Sleep Interference
timeFrame: 14 days
Secondary outcomes:
measure: Changes in Pain Medication Use
timeFrame: 14 days
measure: Changes in Sleep Medication Use
timeFrame: 14 days
measure: Changes in Awakenings during sleep
timeFrame: 14 days
Other outcomes:
measure: Any side effects reported by patients will be documented and assessed by clinician and PI
timeFrame: 14 days
Locations:
city: Tyrone
country: United States
facility: Stein Medical
state: Georgia
Study officials:
affiliation: Stein Medical Center
name: Janet Fason, DO
role: PRINCIPAL_INVESTIGATOR
References: